JP7634160B2 - Solid preparations - Google Patents
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- JP7634160B2 JP7634160B2 JP2020172258A JP2020172258A JP7634160B2 JP 7634160 B2 JP7634160 B2 JP 7634160B2 JP 2020172258 A JP2020172258 A JP 2020172258A JP 2020172258 A JP2020172258 A JP 2020172258A JP 7634160 B2 JP7634160 B2 JP 7634160B2
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- 238000002360 preparation method Methods 0.000 title claims description 49
- 239000007787 solid Substances 0.000 title claims description 44
- 244000134552 Plantago ovata Species 0.000 claims description 49
- 235000003421 Plantago ovata Nutrition 0.000 claims description 49
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 claims description 40
- 239000000203 mixture Substances 0.000 claims description 31
- 239000000395 magnesium oxide Substances 0.000 claims description 27
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims description 27
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims description 27
- 238000009472 formulation Methods 0.000 claims description 26
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 claims description 26
- 239000000347 magnesium hydroxide Substances 0.000 claims description 26
- 229910001862 magnesium hydroxide Inorganic materials 0.000 claims description 26
- 239000003826 tablet Substances 0.000 claims description 24
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims description 20
- 239000001095 magnesium carbonate Substances 0.000 claims description 20
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims description 20
- 229910052943 magnesium sulfate Inorganic materials 0.000 claims description 20
- 235000019341 magnesium sulphate Nutrition 0.000 claims description 20
- 239000008147 saline laxative Substances 0.000 claims description 10
- 239000008187 granular material Substances 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 7
- 239000007910 chewable tablet Substances 0.000 claims description 6
- 239000006191 orally-disintegrating tablet Substances 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 6
- 150000007524 organic acids Chemical class 0.000 claims description 5
- 229940068682 chewable tablet Drugs 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 235000019640 taste Nutrition 0.000 description 38
- 238000000034 method Methods 0.000 description 22
- KHOITXIGCFIULA-UHFFFAOYSA-N Alophen Chemical compound C1=CC(OC(=O)C)=CC=C1C(C=1N=CC=CC=1)C1=CC=C(OC(C)=O)C=C1 KHOITXIGCFIULA-UHFFFAOYSA-N 0.000 description 15
- 229960000503 bisacodyl Drugs 0.000 description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 12
- 210000000214 mouth Anatomy 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 7
- 159000000003 magnesium salts Chemical class 0.000 description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 229940079593 drug Drugs 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 238000005469 granulation Methods 0.000 description 6
- 230000003179 granulation Effects 0.000 description 6
- 239000004615 ingredient Substances 0.000 description 5
- 239000008141 laxative Substances 0.000 description 5
- 230000002475 laxative effect Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 239000000796 flavoring agent Substances 0.000 description 4
- 235000013373 food additive Nutrition 0.000 description 4
- 239000002778 food additive Substances 0.000 description 4
- 239000011812 mixed powder Substances 0.000 description 4
- 230000008961 swelling Effects 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 229940069428 antacid Drugs 0.000 description 3
- 239000003159 antacid agent Substances 0.000 description 3
- 235000003599 food sweetener Nutrition 0.000 description 3
- 239000000546 pharmaceutical excipient Substances 0.000 description 3
- 239000003765 sweetening agent Substances 0.000 description 3
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 2
- 206010013911 Dysgeusia Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 2
- -1 acidulants Substances 0.000 description 2
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 2
- 230000001458 anti-acid effect Effects 0.000 description 2
- 235000015165 citric acid Nutrition 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 235000019634 flavors Nutrition 0.000 description 2
- 235000013355 food flavoring agent Nutrition 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 210000001156 gastric mucosa Anatomy 0.000 description 2
- 229940093915 gynecological organic acid Drugs 0.000 description 2
- 230000000968 intestinal effect Effects 0.000 description 2
- 210000000936 intestine Anatomy 0.000 description 2
- 210000002429 large intestine Anatomy 0.000 description 2
- 229940125722 laxative agent Drugs 0.000 description 2
- 239000001630 malic acid Substances 0.000 description 2
- 235000011090 malic acid Nutrition 0.000 description 2
- 235000005985 organic acids Nutrition 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 230000009747 swallowing Effects 0.000 description 2
- 239000011975 tartaric acid Substances 0.000 description 2
- 235000002906 tartaric acid Nutrition 0.000 description 2
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 description 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
- 239000009223 Psyllium Substances 0.000 description 1
- 244000228451 Stevia rebaudiana Species 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- 239000004376 Sucralose Substances 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 235000011054 acetic acid Nutrition 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000001361 adipic acid Substances 0.000 description 1
- 235000011037 adipic acid Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 229940124579 cold medicine Drugs 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 230000013872 defecation Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 239000007938 effervescent tablet Substances 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000004088 foaming agent Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- 235000011087 fumaric acid Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000000174 gluconic acid Substances 0.000 description 1
- 235000012208 gluconic acid Nutrition 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 230000008855 peristalsis Effects 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 229940070687 psyllium Drugs 0.000 description 1
- HELXLJCILKEWJH-NCGAPWICSA-N rebaudioside A Chemical compound O([C@H]1[C@H](O)[C@@H](CO)O[C@H]([C@@H]1O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HELXLJCILKEWJH-NCGAPWICSA-N 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 235000019600 saltiness Nutrition 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Description
本発明は、固形製剤に関し、不快味を有する有効成分を配合した優れた服用性を有する製剤に関する。 The present invention relates to a solid preparation that contains an active ingredient that has an unpleasant taste and has excellent swallowability.
酸化マグネシウムや水酸化マグネシウム、硫酸マグネシウム、炭酸マグネシウム等の塩類下剤は、大腸において水分の吸収を抑制し、腸内で便に水分を含ませ膨大・軟化させることで排便を促す作用があり、副作用の少ない緩下剤として広く用いられている。また、医薬品分野において制酸作用等を有するため、制酸剤や胃粘膜保護成分として、胃腸薬、瀉下薬、かぜ薬などの経口内服薬に広く利用されている。 Saline laxatives such as magnesium oxide, magnesium hydroxide, magnesium sulfate, and magnesium carbonate have the effect of suppressing water absorption in the large intestine and promoting bowel movements by absorbing water into the stool, swelling it, and softening it in the intestine, and are widely used as laxatives with few side effects. In addition, because they have antacid effects in the pharmaceutical field, they are widely used as antacids and gastric mucosa protective ingredients in oral medications such as gastrointestinal medicines, laxatives, and cold medicines.
ビサコジルは大腸粘膜に直接作用し、腸のぜん動運動を促進して排便を促す瀉下剤として、主に経口投与で広く使われている（特許文献１）。経口投与では、胃内で分解されて効果が低下したり、胃粘膜に無用な刺激をもたらすのを避けるため、腸内で溶けるように錠剤がコーティング等された腸溶製剤が多い。また腸溶製剤の場合、胃内でビサコジルが溶け出すおそれがあるため、服用前後１時間以内は制酸成分を含む胃腸薬の服用や牛乳の摂取を避けることとされている。 Bisacodyl acts directly on the mucous membrane of the large intestine, promoting intestinal peristalsis and encouraging defecation, and is widely used, primarily by oral administration (Patent Document 1). For oral administration, many enteric-coated tablets are used, in which the tablet is coated to dissolve in the intestine, to avoid degradation in the stomach, which reduces its effectiveness, or to avoid unnecessary irritation to the gastric mucosa. In the case of enteric-coated preparations, there is also the risk that bisacodyl may dissolve in the stomach, so it is recommended that patients avoid taking gastrointestinal medicines containing antacid ingredients or ingesting milk within one hour before or after taking the preparation.
これらの有効成分は広く使用されている一方で、特有の不快味（苦味、塩味等）を有することが報告されている（特許文献２、特許文献３）。 While these active ingredients are widely used, they have been reported to have a particular unpleasant taste (bitterness, saltiness, etc.) (Patent Document 2, Patent Document 3).
経口投与製剤の不快味は、その服用感を損なわせ、服薬コンプライアンスを低下させる原因となる（特許文献４）。特に、散剤、顆粒剤や口腔内崩壊錠、チュアブル錠、素錠等の剤形の経口剤の場合、経口剤の成分と舌との接触が多くなるため、不快味による服用感の悪化は顕著となる。 The unpleasant taste of an orally administered formulation impairs the feeling of taking the formulation and reduces compliance (Patent Document 4). In particular, in the case of oral preparations in the form of powders, granules, orally disintegrating tablets, chewable tablets, plain tablets, etc., there is a lot of contact between the components of the oral preparation and the tongue, so the deterioration of the feeling of taking the preparation due to the unpleasant taste is significant.
今までに、酸化マグネシウム、水酸化マグネシウム、ビサコジルの不快味を抑制する方法はいくつか報告されている。例えば、酸化マグネシウム、水酸化マグネシウムの不快味抑制方法としては、ステビアを組み合わせることにより、服用感、風味及び後味の改善された経口用組成物が得られたことが報告されている（特許文献５）。また、特許文献２では酸化マグネシウムや水酸化マグネシウム、炭酸マグネシウムのような塩基性無機塩類の不快味抑制方法として、乳酸塩及びスクラロースを組み合わせることにより、服用感、風味及び後味の改善された経口用組成物が得られたことが報告されている。またビサコジルにおいては、不快味のマスキング法として特定の賦形剤を含有したコーティング方法が報告されている（特許文献６）。しかし、これらの方法は、特定の甘味剤や特定の賦形剤の使用が必須になること及びコーティング工程を必要とすることから、原料コストの増大や工程時間の延長になり、未だ検討の余地がある。 Up to now, several methods have been reported for suppressing the unpleasant taste of magnesium oxide, magnesium hydroxide, and bisacodyl. For example, as a method for suppressing the unpleasant taste of magnesium oxide and magnesium hydroxide, it has been reported that an oral composition with improved swallowing comfort, flavor, and aftertaste was obtained by combining stevia (Patent Document 5). In addition, Patent Document 2 reports that an oral composition with improved swallowing comfort, flavor, and aftertaste was obtained by combining lactate and sucralose as a method for suppressing the unpleasant taste of basic inorganic salts such as magnesium oxide, magnesium hydroxide, and magnesium carbonate. In addition, for bisacodyl, a coating method containing a specific excipient has been reported as a method for masking the unpleasant taste (Patent Document 6). However, these methods require the use of a specific sweetener or specific excipient and require a coating process, which increases the cost of raw materials and extends the process time, and there is still room for further study.
本発明の目的は、塩類下剤のマグネシウム塩又はビサコジルの不快味を改善した固形製剤を提供することである。 The object of the present invention is to provide a solid preparation that improves the unpleasant taste of magnesium salt or bisacodyl, which is a saline laxative.
本発明者らは、上記課題を解決すべく種々の検討を行った結果、驚くべきことに、膨潤性下剤であるプランタゴ・オバタを配合すると、不快味を改善することができ、さらには口腔内でのざらつきも改善することを見出し、服用性をさらに向上させることができ本発明を完成するに至った。 The inventors conducted various studies to solve the above problems, and surprisingly found that adding the swelling laxative Plantago ovata improved the unpleasant taste and also reduced the roughness in the mouth, further improving ease of administration and leading to the completion of the present invention.
すなわち、本発明は、
（１）（Ａ）塩類下剤のマグネシウム塩、及びビサコジルからなる群から選ばれる少なくとも１種、及び（Ｂ）プランタゴ・オバタを含有し、
成分（Ａ）が酸化マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）酸化マグネシウム１質量部に対して１０～２０質量部であり、
成分（Ａ）が水酸化マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）水酸化マグネシウム１質量部に対して２～２０質量部であり、
成分（Ａ）が硫酸マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）硫酸マグネシウム１質量部に対して０．１～５質量部
であることを特徴とする固形製剤、
（２）（Ａ）塩類下剤のマグネシウム塩が酸化マグネシウム、水酸化マグネシウム、硫酸マグネシウム、及び炭酸マグネシウムからなる群より選ばれる少なくとも１種である（１）に記載の固形製剤。
（３）成分（Ａ）が炭酸マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）炭酸マグネシウム１質量部に対して０．１～１０質量部であることを特徴とする（１）又は（２）に記載の固形製剤、
（４）（Ｂ）プランタゴ・オバタの含有量が、固形製剤全体に対して１０～９５質量％である、（１）～（３）のいずれかに記載の固形製剤、
（５）（Ａ）酸化マグネシウムの含有量が、固形製剤全体に対して１～９質量％である、（１）、（２）又は（４）のいずれかに記載の固形製剤、
（６）（Ａ）水酸化マグネシウムの含有量が、固形製剤全体に対して５～４０質量％である、（１）、（２）又は（４）のいずれかに記載の固形製剤、
（７）さらに有機酸を含む（１）～（６）のいずれかに記載の固形製剤、
（８）剤形が口腔内崩壊錠、チュアブル錠、素錠、顆粒剤、又は散剤である（１）～（７）のいずれかに記載の固形製剤、
（９）（Ｂ）プランタゴ・オバタが、プランタゴ・オバタ種子、又はプランタゴ・オバタ種皮である、（１）～（８）のいずれかに記載の固形製剤、
である。
That is, the present invention provides
(1) A laxative comprising (A) at least one selected from the group consisting of magnesium salt of saline laxative and bisacodyl, and (B) Plantago ovata;
When component (A) is magnesium oxide, the content of component (B) is 10 to 20 parts by mass per part by mass of magnesium oxide (A),
When component (A) is magnesium hydroxide, the content of component (B) is 2 to 20 parts by mass per part by mass of magnesium hydroxide (A),
A solid preparation characterized in that, when component (A) is magnesium sulfate, the content of component (B) is 0.1 to 5 parts by mass per 1 part by mass of magnesium sulfate (A).
(2) (A) The solid preparation according to (1), wherein the magnesium salt of the saline laxative is at least one selected from the group consisting of magnesium oxide, magnesium hydroxide, magnesium sulfate, and magnesium carbonate.
(3) The solid preparation according to (1) or (2), wherein when the component (A) is magnesium carbonate, the content of the component (B) is 0.1 to 10 parts by mass per 1 part by mass of the magnesium carbonate (A).
(4) (B) The solid formulation according to any one of (1) to (3), wherein the content of Plantago ovata is 10 to 95% by mass based on the total mass of the solid formulation.
(5) The solid preparation according to any one of (1), (2) and (4), wherein the content of magnesium oxide (A) is 1 to 9% by mass based on the total mass of the solid preparation.
(6) (A) The solid preparation according to any one of (1), (2) and (4), wherein the content of magnesium hydroxide is 5 to 40% by mass based on the total mass of the solid preparation.
(7) The solid formulation according to any one of (1) to (6), further comprising an organic acid.
(8) The solid preparation according to any one of (1) to (7), which has a dosage form of an orally disintegrating tablet, a chewable tablet, a plain tablet, a granule, or a powder.
(9) (B) The solid formulation according to any one of (1) to (8), wherein the Plantago ovata is a Plantago ovata seed or a Plantago ovata seed coat.
It is.
本発明により、塩類下剤のマグネシウム塩又はビサコジルの不快味が抑制され、服用感が良好な固形製剤の提供が可能となった。 The present invention makes it possible to provide a solid preparation that is easy to swallow by suppressing the unpleasant taste of magnesium salt or bisacodyl, which are saline laxatives.
本発明における塩類下剤のマグネシウム塩としては、酸化マグネシウム、水酸化マグネシウム、炭酸マグネシウム、硫酸マグネシウム等が挙げられる。 Examples of magnesium salts in the saline laxative of the present invention include magnesium oxide, magnesium hydroxide, magnesium carbonate, magnesium sulfate, etc.
本発明に用いられる酸化マグネシウムは、日本薬局方又は食品添加物に準拠した酸化マグネシウムであり、公知の方法により製造できるほか、市販のものを用いることができる。本発明の酸化マグネシウムの含有量は、服用性の観点から、本発明の固形製剤全体に対して、１～９質量％が好ましく、５～９質量％がより好ましい。 The magnesium oxide used in the present invention is magnesium oxide that complies with the Japanese Pharmacopoeia or food additives, and can be produced by known methods, or commercially available products can be used. From the viewpoint of ingestibility, the content of magnesium oxide in the present invention is preferably 1 to 9% by mass, and more preferably 5 to 9% by mass, based on the total mass of the solid preparation of the present invention.
本発明における水酸化マグネシウムは日本薬局方外医薬品規格又は食品添加物に準拠した水酸化マグネシウムであり、公知の方法により製造できるほか、市販のものを用いることができる。本発明の水酸化マグネシウムの含有量は、服用性の観点から本発明の固形製剤全体に対して、１～５０質量％が好ましく、５～４０質量％がより好ましく、５～３３質量％がさらに好ましい。 The magnesium hydroxide in the present invention is magnesium hydroxide that complies with the Japanese Pharmacopoeia Pharmaceutical Standards or Food Additives Standards, and can be produced by known methods, or commercially available products can be used. From the viewpoint of ease of administration, the content of the magnesium hydroxide in the present invention is preferably 1 to 50% by mass, more preferably 5 to 40% by mass, and even more preferably 5 to 33% by mass, based on the total mass of the solid preparation of the present invention.
本発明に用いられる炭酸マグネシウムは、日本薬局方又は食品添加物に準拠した炭酸マグネシウムであり、公知の方法により製造できるほか、市販のものを用いることができる。本発明の炭酸マグネシウムの含有量は、服用性の観点から、本発明の固形製剤全体に対して、１０～９０質量％が好ましく、１２～８６質量％がより好ましい。 The magnesium carbonate used in the present invention is magnesium carbonate that complies with the Japanese Pharmacopoeia or food additives, and can be produced by known methods, or commercially available products can be used. From the viewpoint of ease of administration, the content of magnesium carbonate in the present invention is preferably 10 to 90% by mass, and more preferably 12 to 86% by mass, based on the total mass of the solid preparation of the present invention.
本発明に用いられる硫酸マグネシウムは、日本薬局方又は食品添加物に準拠した硫酸マグネシウムであり、公知の方法により製造できるほか、市販のものを用いることができる。本発明の硫酸マグネシウムの含有量は、服用性の観点から、本発明の固形製剤全体に対して、１０～９０質量％が好ましく、２０～８６質量％がより好ましい。 The magnesium sulfate used in the present invention is magnesium sulfate conforming to the Japanese Pharmacopoeia or food additives, and can be produced by known methods, or commercially available products can be used. From the viewpoint of ingestibility, the content of magnesium sulfate in the present invention is preferably 10 to 90% by mass, and more preferably 20 to 86% by mass, based on the total mass of the solid preparation of the present invention.
本発明におけるビサコジルは日本薬局方に準拠したビサコジルであり、公知の方法により製造できるほか、市販のものを用いることができる。本発明のビサコジルの含有量は、服用性及びの観点から本発明の固形製剤全体に対して、０．０００１～１質量％が好ましく、０．０００１～０．８５質量％がより好ましい。 The bisacodyl used in the present invention is bisacodyl that conforms to the Japanese Pharmacopoeia and can be produced by known methods, or commercially available products can be used. From the viewpoint of ease of administration, the content of bisacodyl in the present invention is preferably 0.0001 to 1% by mass, and more preferably 0.0001 to 0.85% by mass, based on the total mass of the solid preparation of the present invention.
本発明におけるプランタゴ・オバタは、種子、茎、葉、根等、使用部位は限定しないが、膨潤性瀉下成分（サイリウムガム）を多く含む種子が好ましい。また種子を使用する場合は、種子全体、種皮のみのいずれを用いてもよいが、種皮又は種皮末がより好ましい。プランタゴ・オバタは、水分を吸収して膨潤することにより腸壁を物理的に刺激すると共に、便量を増やすことで瀉下作用をもたらすものである。本発明のプランタゴ・オバタの１日あたりの服用量は、１０５０～１０５００ｍｇが好ましく、２１００～１０５００ｍｇがより好ましい。本発明のプランタゴ・オバタの含有量は、瀉下作用を発揮する観点から、本発明の固形製剤全体に対して１０～９５質量％が好ましい。
本発明において酸化マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、６０～９５質量％が好ましく、８４～９２質量％がより好ましい。水酸化マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、４０～９５質量％が好ましく、５０～９４質量％がより好ましく、５５～９２質量％がさらに好ましい。炭酸マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、５～８５質量％が好ましく、１０～８５質量％がより好ましい。硫酸マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、５～８５質量％が好ましく、１０～７７質量％が好ましい。ビサコジルを配合する場合、プランタゴ・オバタの配合量は、７５～９０質量％が好ましい。
The parts of Plantago ovata used in the present invention are not limited to seeds, stems, leaves, roots, etc., but seeds containing a large amount of swelling laxative component (psyllium gum) are preferred. When seeds are used, either the whole seed or only the seed coat may be used, but seed coat or seed coat powder is more preferred. Plantago ovata physically stimulates the intestinal wall by absorbing water and swelling, and also increases the amount of stool, thereby exerting a laxative effect. The daily dose of Plantago ovata of the present invention is preferably 1050 to 10500 mg, more preferably 2100 to 10500 mg. From the viewpoint of exerting a laxative effect, the content of Plantago ovata of the present invention is preferably 10 to 95% by mass based on the total mass of the solid preparation of the present invention.
In the present invention, when magnesium oxide and Plantago ovata are blended, the blending amount of Plantago ovata is preferably 60 to 95% by mass, more preferably 84 to 92% by mass. When magnesium hydroxide and Plantago ovata are blended, the blending amount of Plantago ovata is preferably 40 to 95% by mass, more preferably 50 to 94% by mass, and even more preferably 55 to 92% by mass. When magnesium carbonate and Plantago ovata are blended, the blending amount of Plantago ovata is preferably 5 to 85% by mass, more preferably 10 to 85% by mass. When magnesium sulfate and Plantago ovata are blended, the blending amount of Plantago ovata is preferably 5 to 85% by mass, and more preferably 10 to 77% by mass. When bisacodyl is blended, the blending amount of Plantago ovata is preferably 75 to 90% by mass.
また、本発明において、酸化マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、酸化マグネシウムの不快味抑制又は口腔内でのざらつき改善の点から、酸化マグネシウム１質量部に対して１０～２０質量部であり、更に好ましくは１２～２０質量部であり、より好ましくは１２～１７．５質量部である。
本発明の固形製剤において、水酸化マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、水酸化マグネシウムの不快味抑制又は及び口腔内でのざらつき改善の点から、水酸化マグネシウム１質量部に対して２～２０質量部であり、好ましくは２～１６．７質量部、より好ましくは３．３～１６．７質量部である。
本発明の固形製剤において、硫酸マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、硫酸マグネシウムの不快味抑制又は及び口腔内でのざらつき改善の点から、硫酸マグネシウム１質量部に対して０．１～５質量部であり、好ましくは０．１４～３．５質量部である。
本発明の固形製剤において、炭酸マグネシウムとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、炭酸マグネシウムの不快味抑制又は及び口腔内でのざらつき改善の点から、炭酸マグネシウム１質量部に対して０．１～１０質量部であり、好ましくは０．１～７質量部である。
In addition, in the present invention, when magnesium oxide and Plantago ovata are combined, the amount of Plantago ovata combined is 10 to 20 parts by mass, more preferably 12 to 20 parts by mass, and even more preferably 12 to 17.5 parts by mass per part by mass of magnesium oxide, in order to suppress the unpleasant taste of magnesium oxide or improve roughness in the oral cavity.
When magnesium hydroxide and Plantago ovata are combined in the solid preparation of the present invention, the amount of Plantago ovata to be combined is 2 to 20 parts by mass, preferably 2 to 16.7 parts by mass, and more preferably 3.3 to 16.7 parts by mass, per part by mass of magnesium hydroxide, from the viewpoint of suppressing the unpleasant taste of magnesium hydroxide and improving roughness in the oral cavity.
When magnesium sulfate and Plantago ovata are combined in the solid preparation of the present invention, the amount of Plantago ovata to be combined is 0.1 to 5 parts by mass, preferably 0.14 to 3.5 parts by mass, per part by mass of magnesium sulfate in order to suppress the unpleasant taste of magnesium sulfate and/or improve roughness in the oral cavity.
When magnesium carbonate and Plantago ovata are blended in the solid preparation of the present invention, the amount of Plantago ovata blended is 0.1 to 10 parts by mass, preferably 0.1 to 7 parts by mass, per part by mass of magnesium carbonate, from the viewpoint of suppressing the unpleasant taste of magnesium carbonate and improving roughness in the oral cavity.
また、本発明において、ビサコジルとプランタゴ・オバタを配合する場合、プランタゴ・オバタの配合量は、ビサコジル１質量部に対して１０５～５２５質量部が好ましい。 In addition, in the present invention, when bisacodyl and Plantago ovata are combined, the amount of Plantago ovata combined is preferably 105 to 525 parts by mass per 1 part by mass of bisacodyl.
本発明の固形製剤には、可食性の酸として有機酸を使用することができる。例えば、クエン酸、コハク酸、アスコルビン酸、酢酸、グルコン酸、リンゴ酸、酒石酸、フマル酸、アジピン酸等の有機酸が挙げられ、これらは単独で又は２種以上を組み合わせて用いることができる。なかでもクエン酸、リンゴ酸、酒石酸が好ましい。これら有機酸の含有量は、本発明の固形製剤全体に対して、１～７０質量％が好ましく、１～５０質量％がより好ましく、１～３０質量％が更に好ましく、２．４～２７質量％が最も好ましい。
本発明の固形製剤は特に制限されるものではないが、例えば医薬品、医薬部外品、食品等が挙げられる。好ましくは医薬品、医薬部外品である。
In the solid preparation of the present invention, an organic acid can be used as an edible acid. Examples of the organic acids include citric acid, succinic acid, ascorbic acid, acetic acid, gluconic acid, malic acid, tartaric acid, fumaric acid, adipic acid, etc., which can be used alone or in combination of two or more. Among them, citric acid, malic acid, and tartaric acid are preferred. The content of these organic acids is preferably 1 to 70% by mass, more preferably 1 to 50% by mass, even more preferably 1 to 30% by mass, and most preferably 2.4 to 27% by mass, based on the total mass of the solid preparation of the present invention.
The solid preparation of the present invention is not particularly limited, and examples thereof include medicines, quasi-drugs, foods, etc. Preferred are medicines and quasi-drugs.
本発明の製剤には、本発明の効果に支障のない限り、一般に用いられる種々の添加剤を含んでいてもよい。このような添加剤として、例えば、賦形剤、崩壊剤、結合剤、流動化剤、滑沢剤、酸味剤、発泡剤、甘味剤、嬌味剤、香料、着色剤、界面活性剤、可塑剤等が挙げられるが、不快味の観点からは甘味剤、矯味剤を含有することがより好ましい。 The formulation of the present invention may contain various commonly used additives as long as they do not impair the effects of the present invention. Examples of such additives include excipients, disintegrants, binders, flow agents, lubricants, acidulants, foaming agents, sweeteners, flavoring agents, flavorings, colorants, surfactants, plasticizers, etc., but from the viewpoint of preventing unpleasant tastes, it is more preferable to contain sweeteners and flavoring agents.
本製剤の剤形は、例えば、錠剤、顆粒剤、散剤が挙げられる。これらは、水に溶かして服用するタイプの固形製剤であってもよい。本発明の錠剤には、日本薬局方の製剤通則に規定されている口腔内崩壊錠、チュアブル錠、素錠、発泡錠、分散錠及び溶解錠が含まれる。 The dosage form of the present preparation may be, for example, a tablet, a granule, or a powder. These may be solid preparations that are dissolved in water and taken. The tablets of the present invention include orally disintegrating tablets, chewable tablets, plain tablets, effervescent tablets, dispersible tablets, and dissolving tablets as specified in the General Rules for Preparations of the Japanese Pharmacopoeia.
また、本発明の固形製剤が水に溶かして服用するタイプの固形製剤であっても、塩類下剤のマグネシウム塩の不快味は改善される。また、本発明の固形製剤が、口腔内崩壊錠やチュアブル錠のように水なしでそのまま服用する製剤、あるいは口に含めてから水と一緒に飲み込む製剤の場合、口腔内でのざらつきも改善できる。 In addition, even if the solid preparation of the present invention is a type that is dissolved in water and taken, the unpleasant taste of the magnesium salt of a saline laxative is improved. In addition, if the solid preparation of the present invention is a preparation that is taken as is without water, such as an orally disintegrating tablet or a chewable tablet, or a preparation that is placed in the mouth and then swallowed with water, the roughness in the oral cavity can also be improved.
本発明の錠剤に割線や識別性向上のためのマーク、刻印を設けることができる。さらに、本製剤の錠剤は、丸錠であってもよいし、異型錠であってもよい。また、本発明においては、味を感じる観点から、口腔内崩壊錠、チュアブル錠、素錠、顆粒剤、散剤で実施する意義がより大きい。
本発明の錠剤には、従来行われている錠剤の製造方法により、製造することができる。すなわち、本製剤は、医薬有効成分と上述のような添加剤を混合機などの適当な混合機で混合して錠剤用混合末を製造した後、当該混合末を直接圧縮打錠する方法、または、顆粒を圧縮打錠する方法等により製造することができる。顆粒の製造方法は、乾式造粒法（スラッグ法、ローラーコンパクター法）、湿式造粒法により製造することができ、造粒装置としては、ローラーコンパクター、撹拌造粒法、流動層造粒法、押し出し造粒法、転動造粒法、噴霧造粒法等で製造すればよい。錠剤用混合末または当該混合末の顆粒を圧縮打錠する機械としては、単発打錠機、ロータリー式打錠機等を用いることができる。
The tablet of the present invention may be provided with a score line, a mark for improving identification, or a stamp. Furthermore, the tablet of the present preparation may be a round tablet or an irregular tablet. In addition, in the present invention, from the viewpoint of taste, it is more significant to carry out the present invention in the form of an orally disintegrating tablet, a chewable tablet, a plain tablet, a granule, or a powder.
The tablet of the present invention can be manufactured by a conventional tablet manufacturing method. That is, the present preparation can be manufactured by mixing the medicamentous active ingredient and the additives as described above in an appropriate mixer such as a mixer to manufacture a mixed powder for tablets, and then directly compressing the mixed powder into tablets, or by compressing and tableting granules. Granules can be manufactured by dry granulation (slug method, roller compactor method) or wet granulation, and the granulation device may be a roller compactor, stirring granulation method, fluidized bed granulation method, extrusion granulation method, rolling granulation method, spray granulation method, etc. As a machine for compressing and tableting the mixed powder for tablets or the granules of the mixed powder, a single punch tablet machine, a rotary tablet machine, etc. can be used.
以下に実施例及び比較例を挙げ、本発明をより詳しく説明するが、本発明はこれら実施例等に限定されるものではない。 The present invention will be described in more detail below with reference to examples and comparative examples, but the present invention is not limited to these examples.
（製剤の調製）
（実施例１～１２、比較例１～８）
表１～２に記載の配合組成で各原料成分を秤量した後、均一に混合した。混合物と適量の水及びエタノールの混液を加え乳鉢で練合、造粒した後、十分に乾燥させた。その後全量を篩（目開き５００μｍ）に通過させ造粒物を得た後、これを３包分とした。
Preparation of Formulations
(Examples 1 to 12, Comparative Examples 1 to 8)
Each raw material component was weighed according to the composition shown in Tables 1 and 2, and then mixed uniformly. The mixture was mixed with an appropriate amount of a mixture of water and ethanol, kneaded in a mortar, granulated, and then thoroughly dried. The entire amount was then passed through a sieve (mesh opening 500 μm) to obtain granules, which were then divided into three packets.
＜服用性試験＞
実施例１～１２、及び比較例１～８の各製剤について、専門パネル２名による官能評価を行った。
服用方法は、製剤１包を口に含んでから水と一緒に服用する方法（服用方法１）と、水に溶かしてから服用する方法（服用方法２）の２パターンを行い、服用にはコップ１杯の水を用いた。
服用方法１については不快味とざらつきの評価を行い、服用方法２については不快味の評価を行った。不快味及びざらつきについて、下記に示す判断基準に従って評価を行い、専門パネルの平均値を算出した。
<Usability test>
For each of the preparations of Examples 1 to 12 and Comparative Examples 1 to 8, a sensory evaluation was carried out by two expert panelists.
The dosage was administered in two ways: by placing a packet of the formulation in the mouth and then taking it with water (Method 1), and by dissolving the formulation in water and then taking it (Method 2).A full glass of water was used for administration.
The unpleasant taste and roughness were evaluated for Method 1, and the unpleasant taste was evaluated for Method 2. The unpleasant taste and roughness were evaluated according to the following criteria, and the average scores of the expert panel were calculated.
＜不快味＞
０：不快味を感じない
１：不快味をわずかに感じる
２：不快味をやや感じる
３：不快味を感じる
４：不快味を強く感じる
＜ざらつき＞
０：ざらつきを感じない
１：ざらつきをわずかに感じる
２：ざらつきをやや感じる
３：ざらつきを感じる
４：ざらつきを強く感じる
＜Unpleasant taste＞
0: No unpleasant taste 1: Slightly unpleasant taste 2: Slightly unpleasant taste 3: Unpleasant taste 4: Strongly unpleasant taste <Roughness>
0: No roughness felt 1: Slightly roughness felt 2: Slightly roughness felt 3: Roughness felt 4: Strong roughness felt
結果を表１に示す。 The results are shown in Table 1.
表１～２に示すように、水酸化マグネシウム１質量部に対してプランタゴ・オバタを配合しない製剤及びプランタゴ・オバタを１質量部配合した製剤では不快味及びざらつきが感じられた（比較例１～３）。これに対し、水酸化マグネシウム１質量部に対してプランタゴ・オバタの配合比が２質量部である本発明品は不快味が軽減し、ざらつきも軽減した（実施例３、４）。また、製剤を水に溶かして飲むと不快味は全く感じられなかった（実施例３、４）。水酸化マグネシウム１質量部に対してプランタゴ・オバタの配合量を２５．４質量部まで増量すると、不快味は改善されたもののざらつきが生じた。さらに、服用時に口の中で製剤が一塊になってしまい、飲み込むことができなくなった（比較例４）。 As shown in Tables 1 and 2, the formulations without Plantago ovata and with 1 part by mass of Plantago ovata per part by mass of magnesium hydroxide had an unpleasant taste and roughness (Comparative Examples 1 to 3). In contrast, the product of the present invention, in which the ratio of Plantago ovata to magnesium hydroxide was 2 parts by mass, had a reduced unpleasant taste and roughness (Examples 3 and 4). Furthermore, when the formulation was dissolved in water and taken, no unpleasant taste was felt at all (Examples 3 and 4). When the amount of Plantago ovata per part by mass of magnesium hydroxide was increased to 25.4 parts by mass, the unpleasant taste was improved but roughness occurred. Furthermore, the formulation became a lump in the mouth when taken, making it impossible to swallow (Comparative Example 4).
また、表１に示すように、ビサコジルにおいてもプランタゴ・オバタを配合することにより不快味を改善できた（実施例５、６）。 As shown in Table 1, the unpleasant taste of bisacodyl could also be improved by adding Plantago ovata (Examples 5 and 6).
酸化マグネシウムについて、ざらつきはいずれの処方においても２以下であったが、不快味はプランタゴ・オバタの配合量の増大に伴い軽減する傾向が示された。酸化マグネシウム１質量部に対しプランタゴ・オバタを３．５質量部配合した製剤及び９質量部配合した製剤は、両者とも不快味は感じた。一方、酸化マグネシウム１質量部に対してプランタゴ・オバタを１０質量部以上配合すると不快味は改善された（実施例７～９、比較例６～７）。 For magnesium oxide, the roughness was 2 or less in all formulations, but the unpleasant taste tended to decrease with increasing amounts of Plantago ovata. Both formulations containing 3.5 parts by mass of Plantago ovata per part by mass of magnesium oxide and formulations containing 9 parts by mass of Plantago ovata per part by mass of magnesium oxide produced an unpleasant taste. On the other hand, the unpleasant taste was improved when 10 parts by mass or more of Plantago ovata were added per part by mass of magnesium oxide (Examples 7-9, Comparative Examples 6-7).
（製剤例）
（製剤例１、２、４、５）
１２錠中に下記成分および分量をとり、日局製剤総則に準じ製造した。
（製剤例３、６）
６包中に下記成分および分量をとり、日局製剤総則に準じ製造した。
（製剤例７、８）
２４錠中に下記成分および分量をとり、日局製剤総則に準じ製造した。
(Formulation example)
(Formulation Examples 1, 2, 4, and 5)
The following ingredients and amounts were used in 12 tablets, and the tablets were produced in accordance with the General Provisions of the Japanese Pharmacopoeia.
(Formulation Examples 3 and 6)
The following ingredients and amounts were placed in 6 packets and prepared in accordance with the General Provisions of the Japanese Pharmacopoeia.
(Formulation Examples 7 and 8)
The following ingredients and amounts were used in 24 tablets, and the tablets were produced in accordance with the General Provisions of the Japanese Pharmacopoeia.
本発明の製剤例を以下表４に示す。 Examples of formulations of the present invention are shown in Table 4 below.
本発明によれば、塩類下剤のマグネシウム塩又はビサコジルの不快味を改善した固形製剤を提供することができる。 The present invention provides a solid preparation that improves the unpleasant taste of magnesium salt or bisacodyl, a saline laxative.
Claims (8)
成分（Ａ）が酸化マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）酸化マグネシウム１質量部に対して１０～２０質量部であり、
成分（Ａ）が水酸化マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）水酸化マグネシウム１質量部に対して２～２０質量部であり、
成分（Ａ）が硫酸マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）硫酸マグネシウム１質量部に対して０．１～５質量部であり、
成分（Ａ）が炭酸マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）炭酸マグネシウム１質量部に対して０．１～１０質量部
であることを特徴とする経口用固形製剤。 (A) at least one saline laxative selected from magnesium oxide, magnesium hydroxide, magnesium sulfate, and magnesium carbonate ; and (B) Plantago ovata,
When component (A) is magnesium oxide, the content of component (B) is 10 to 20 parts by mass per part by mass of magnesium oxide (A),
When component (A) is magnesium hydroxide, the content of component (B) is 2 to 20 parts by mass per part by mass of magnesium hydroxide (A),
When component (A) is magnesium sulfate, the content of component (B) is 0.1 to 5 parts by mass per part by mass of magnesium sulfate (A),
When component (A) is magnesium carbonate, the content of component (B) is 0.1 to 10 parts by mass per part by mass of magnesium carbonate (A).
1. A solid formulation for oral administration , comprising:
成分（Ａ）が酸化マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）酸化マグネシウム１質量部に対して１０～２０質量部であり、When component (A) is magnesium oxide, the content of component (B) is 10 to 20 parts by mass per part by mass of magnesium oxide (A),
成分（Ａ）が水酸化マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）水酸化マグネシウム１質量部に対して２～２０質量部であり、When component (A) is magnesium hydroxide, the content of component (B) is 2 to 20 parts by mass per part by mass of magnesium hydroxide (A),
成分（Ａ）が硫酸マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）硫酸マグネシウム１質量部に対して０．１～５質量部であり、When component (A) is magnesium sulfate, the content of component (B) is 0.1 to 5 parts by mass per part by mass of magnesium sulfate (A),
成分（Ａ）が炭酸マグネシウムの場合、（Ｂ）成分の含有量は（Ａ）炭酸マグネシウム１質量部に対して０．１～１０質量部When component (A) is magnesium carbonate, the content of component (B) is 0.1 to 10 parts by mass per part by mass of magnesium carbonate (A).
である経口用固形製剤の製造方法であって、A method for producing a solid preparation for oral administration, comprising the steps of:
前記（Ａ）成分、及び（Ｂ）プランタゴ・オバタを混合する工程を有する、前記固形製剤の製造方法。A method for producing the solid formulation, comprising a step of mixing the component (A) and the Plantago ovata (B).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2019195376 | 2019-10-28 | ||
| JP2019195376 | 2019-10-28 |
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| Application Number | Title | Priority Date | Filing Date |
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| JP2024213029A Division JP2025023304A (en) | 2019-10-28 | 2024-12-06 | Solid preparations |
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| JP2021070685A JP2021070685A (en) | 2021-05-06 |
| JP2021070685A5 JP2021070685A5 (en) | 2023-10-13 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001199894A (en) | 2000-01-19 | 2001-07-24 | Taisho Pharmaceut Co Ltd | Laxative |
| JP2001220352A (en) | 2000-02-08 | 2001-08-14 | Taisho Pharmaceut Co Ltd | Laxative |
| WO2008141368A1 (en) | 2007-05-17 | 2008-11-27 | David Lubowski | Combination laxative compositions comprising a colonic stimulant and a bulking laxative |
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001199894A (en) | 2000-01-19 | 2001-07-24 | Taisho Pharmaceut Co Ltd | Laxative |
| JP2001220352A (en) | 2000-02-08 | 2001-08-14 | Taisho Pharmaceut Co Ltd | Laxative |
| WO2008141368A1 (en) | 2007-05-17 | 2008-11-27 | David Lubowski | Combination laxative compositions comprising a colonic stimulant and a bulking laxative |
Non-Patent Citations (1)
| Title |
|---|
| Veterinary journal，2014年，Vol.202, No.3，pp.608-611 |
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