CN101513531B - Soft capsule matrix and preparation method thereof - Google Patents
Soft capsule matrix and preparation method thereof Download PDFInfo
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- CN101513531B CN101513531B CN2009100481301A CN200910048130A CN101513531B CN 101513531 B CN101513531 B CN 101513531B CN 2009100481301 A CN2009100481301 A CN 2009100481301A CN 200910048130 A CN200910048130 A CN 200910048130A CN 101513531 B CN101513531 B CN 101513531B
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- soft capsule
- oil
- oleum
- melting
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 36
- 238000002360 preparation method Methods 0.000 title claims abstract description 26
- 239000011159 matrix material Substances 0.000 title claims abstract description 17
- 238000002844 melting Methods 0.000 claims abstract description 17
- 230000008018 melting Effects 0.000 claims abstract description 17
- 239000002671 adjuvant Substances 0.000 claims description 18
- 239000007766 cera flava Substances 0.000 claims description 17
- 235000019868 cocoa butter Nutrition 0.000 claims description 17
- 239000003549 soybean oil Substances 0.000 claims description 15
- 235000012424 soybean oil Nutrition 0.000 claims description 15
- 239000003921 oil Substances 0.000 claims description 11
- 235000019198 oils Nutrition 0.000 claims description 11
- 210000000582 semen Anatomy 0.000 claims description 11
- 239000000758 substrate Substances 0.000 claims description 9
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 9
- 239000008158 vegetable oil Substances 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 235000004347 Perilla Nutrition 0.000 claims description 4
- 244000124853 Perilla frutescens Species 0.000 claims description 4
- -1 Synthetic Spermacet Substances 0.000 claims description 4
- 239000007765 cera alba Substances 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 3
- 235000019485 Safflower oil Nutrition 0.000 claims description 2
- 239000004203 carnauba wax Substances 0.000 claims description 2
- 229940110456 cocoa butter Drugs 0.000 claims description 2
- 238000007710 freezing Methods 0.000 claims description 2
- 230000008014 freezing Effects 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 239000004006 olive oil Substances 0.000 claims description 2
- 235000008390 olive oil Nutrition 0.000 claims description 2
- 239000012188 paraffin wax Substances 0.000 claims description 2
- 239000003813 safflower oil Substances 0.000 claims description 2
- 235000005713 safflower oil Nutrition 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 8
- 229940079593 drug Drugs 0.000 abstract description 4
- 238000000034 method Methods 0.000 abstract description 3
- 238000010960 commercial process Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 description 17
- 239000008172 hydrogenated vegetable oil Substances 0.000 description 5
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 4
- CEGOLXSVJUTHNZ-UHFFFAOYSA-K aluminium tristearate Chemical compound [Al+3].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CEGOLXSVJUTHNZ-UHFFFAOYSA-K 0.000 description 3
- 229940075507 glyceryl monostearate Drugs 0.000 description 2
- 238000009413 insulation Methods 0.000 description 2
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 description 2
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000000341 volatile oil Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 241000241413 Propolis Species 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- HESIBZMZTMHXQS-UHFFFAOYSA-M alumanyl octadecanoate Chemical class CCCCCCCCCCCCCCCCCC(=O)O[AlH2] HESIBZMZTMHXQS-UHFFFAOYSA-M 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- UGMCXQCYOVCMTB-UHFFFAOYSA-K dihydroxy(stearato)aluminium Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[Al](O)O UGMCXQCYOVCMTB-UHFFFAOYSA-K 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229940069949 propolis Drugs 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention provides a soft capsule matrix and a preparation method thereof. The soft capsule matrix is prepared by seed fat, low melting point accessories and high melting point accessories according to the definite proportion by weight. The soft capsule matrix is simultaneously suitable for water-solubility, oil solubility or insoluble drug requirements, not only increases the applicable scope of soft capsules, but also reduces the mutual influence of contents and rubber sheets to the utmost extent, overcomes the problem of the unstable nature of the traditional soft capsule, accelerates the disintegration time of the soft capsules. The preparation method thereof has simple technique and the selected accessories are universal and easy to be obtained and suitable for commercial process.
Description
Technical field
The invention belongs to health food, field of pharmaceutical preparations, specifically, relate to a kind of soft capsule composition and preparation method thereof.
Background technology
Soft capsule refers to the quantitative pressure injection of content and is encapsulated in the elastomeric flexible glued membrane and the solid preparation of making, and its content is comprised of medicine and substrate, can be liquid, semisolid or solid.Soft capsule plasticity is strong, and exquisite appearance is easy to be accepted by the patient.At present, soft capsule is applied to Chinese medicine and still belongs to more novel technology, be applicable to oil content high, be insoluble in that water be difficult for to absorb, to light damp and hot unsettled, be easy to medicine oxidation, the tool bad smell, can guarantee quality of item, improve bioavailability.
The traditional soft capsule uses oleaginous base, general oiliness and the low melting point substance of being used for, as Radix Oenotherae erythrosepalae oil soft capsule, male essential oil soft-capsule etc., recent year Study of Traditional Chinese Medicine soft capsule, development rapidly, content is transitioned into suspension, semisolid, greatly increased the scope of application of soft capsule, but the unsettled problem ubiquity of Chinese medicinal soft capsule character, pending, main cause is that content and rubber react, and affects on the one hand content quality stable, or show that effective ingredient reduces, or show that the content physical property changes; Postpone on the other hand soft capsule disintegration, cause product quality defective.The bottleneck of most Chinese medicinal soft capsule also just is being this.
Summary of the invention
The object of the invention is to, a kind of soft capsule matrix and compound method thereof are provided, described substrate has solved above-mentioned technical barrier, can the simultaneous adaptation water solublity, the requirement of oil-soluble or insoluble medicine, not only increase the scope of application of soft capsule, and reduce content to greatest extent and rubber influences each other, guarantee preparation stabilization.
The present invention is achieved by the following technical solutions:
Soft capsule matrix provided by the invention, by vegetable oil, low melting point adjuvant and high-melting-point adjuvant are made by following weight proportion: vegetable oil 0-200 part, low melting point adjuvant 50-100 part, high-melting-point adjuvant 1-20 part.
Soft capsule matrix provided by the invention, preferred mix proportion scheme is: vegetable oil 60-80 part by weight, low melting point adjuvant 65-75 part, high-melting-point adjuvant 8-12 part.
Soft capsule matrix provided by the invention, described low melting point adjuvant is cocoa butter.
Soft capsule matrix provided by the invention, described vegetable oil are selected from one or more of soybean oil, Semen Maydis oil, Oleum Camelliae, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, Oleum sesami, Oleum Gossypii semen, Oleum Helianthi, oleum lini, safflower oil, perilla oil, olive oil.
According to soft capsule matrix provided by the invention, preferably, described vegetable oil is selected from one or both in soybean oil, Semen Maydis oil.
Soft capsule matrix provided by the invention, described high-melting-point adjuvant is selected from Cera Flava, white beeswax, Cera Flava, paraffin, Synthetic Spermacet, Brazil wax, aluminum monostearate, aluminium stearate, Aluminium Tristearate Micronized sterile, stearic acid, stearyl alcohol, glyceryl monostearate, one or more of hexadecanol, hydrogenated vegetable oil, castor oil hydrogenated.
According to soft capsule matrix provided by the invention, preferably, described high-melting-point adjuvant is selected from one or both in Cera Flava, hydrogenated vegetable oil.
Soft capsule matrix provided by the invention, the freezing point of described substrate are 24 ℃-35 ℃, and fusing point is below 37 ℃ or 37 ℃.
The present invention also provides a kind of preparation method of producing described soft capsule matrix, selected vegetable oil, low melting point adjuvant, high-melting-point adjuvant are mixed in proportion, heating makes melting, add appropriate amount of drug, stir, standby in 40 ℃ of insulations, also can cooling rear storage, heating and melting during use stirs.
Soft capsule matrix provided by the invention has overcome the unsettled problem of traditional soft capsule character, accelerates soft capsule disintegration, and its preparation method technique is simple, and selected adjuvant generally is easy to get, and is suitable for suitability for industrialized production.
The specific embodiment
The below will the invention will be further described by embodiment, and these descriptions are not the further restriction to content of the present invention.One skilled in the art will understand that to be equal to replacement to what content of the present invention was done, or corresponding improvement, within still belonging to protection scope of the present invention.
Embodiment 1
Formula:
The composition weight proportion
100 parts of cocoa butters
1 part, Cera Flava
Preparation technology:
Take material by formula, Hybrid Heating is treated melting, stirs, and 40 ℃ of insulations are standby, also can cooling rear storage.Heating and melting during use stirs, and is incubated in 40 ℃ of uses.
Embodiment 2
The composition weight proportion
70 parts of cocoa butters
40 parts of soybean oils
5 parts, Cera Flava
Preparation technology is with embodiment 1.
Embodiment 3
The composition weight proportion
70 parts of cocoa butters
70 parts of soybean oils
10 parts, Cera Flava
Preparation technology is with embodiment 1.
Embodiment 4
The composition weight proportion
75 parts of cocoa butters
65 parts of soybean oils
8 parts of Synthetic Spermacets
Preparation technology is with embodiment 1.
Embodiment 5:
The composition weight proportion
80 parts of cocoa butters
20 parts of soybean oils
30 parts of Semen Maydis oil
6 parts of hydrogenated vegetable oils
Preparation technology is with embodiment 1.
Embodiment 6:
The composition weight proportion
100 parts of cocoa butters
20 parts of soybean oils
10 parts of Semen Maydis oil
10 parts of perilla oils
5.6 parts, Cera Flava
Preparation technology is with embodiment 1.
Embodiment 7:
The composition weight proportion
100 parts of cocoa butters
50 parts of perilla oils
7 parts, Cera Flava
Preparation technology is with embodiment 1.
Embodiment 8:
The composition weight proportion
100 parts of cocoa butters
100 parts of Oleum Arachidis hypogaeae semen
9 parts, Cera Flava
3 parts of Brazil waxs
Preparation technology is with embodiment 1.
Embodiment 9:
The composition weight proportion
100 parts of cocoa butters
100 parts of Oleum Arachidis hypogaeae semen
50 parts of soybean oils
10 parts, Cera Flava
Preparation technology is with embodiment 1.
Embodiment 10:
The composition weight proportion
100 parts of cocoa butters
180 parts of soybean oils
10 parts, Cera Flava
6 parts of stearyl alcohols
2 parts of hydrogenated vegetable oils
Preparation technology is with embodiment 1.
Embodiment 11:
The composition weight proportion
100 parts of cocoa butters
200 parts of soybean oils
10 parts, Cera Flava
6 parts of stearyl alcohols
2 parts of hydrogenated vegetable oils
2 parts of white beeswax
Preparation technology is with embodiment 1.
Embodiment 12:
The composition weight proportion
100 parts of cocoa butters
200 parts of soybean oils
5 parts of aluminium stearate
3 parts of aluminum monostearates
2 parts of glyceryl monostearate
Preparation technology is with embodiment 1.
Embodiment 13:
The composition weight proportion
50 parts of cocoa butters
30 parts of soybean oils
15 parts, Cera Flava
150 parts of Rhizoma Cyperi volatile oil
Preparation technology is with embodiment 1.
Embodiment 14:
The composition weight proportion
65 parts of cocoa butters
160 parts of soybean oils
12 parts, Cera Flava
50 parts of forsythols
Preparation technology is with embodiment 1.
Embodiment 15:
The composition weight proportion
70 parts of cocoa butters
70 parts of soybean oils
10 parts, Cera Flava
100 parts of propolis
Preparation technology is with embodiment 1.
The study on the stability result
Get after embodiment 14 and 15 content fills become the soft capsule finished product, the compacting aluminium-plastic bubble plate packing is in temperature: 30 ℃ ± 2 ℃, humidity: carry out accelerated test, 0,1 under 65% ± 5% condition, 2, took a sample to check in 3,6 months, disintegration is all in 50 minutes, 1,2,3, June, drug content was compared content decline in 0 month all in 10%.
The study on the stability table
Claims (4)
1. soft capsule matrix, it is characterized in that: described substrate is comprised of following ingredients by weight, vegetable oil 60-80 part, low melting point adjuvant 65-75 part, high-melting-point adjuvant 8-12 part, wherein vegetable oil is selected from more than one in soybean oil, Semen Maydis oil, Oleum Camelliae, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, Oleum sesami, Oleum Gossypii semen, Oleum Helianthi, oleum lini, safflower oil, perilla oil, olive oil; The low melting point adjuvant is cocoa butter; The high-melting-point adjuvant is selected from more than one in Cera Flava, white beeswax, Cera Flava, paraffin, Synthetic Spermacet, Brazil wax.
2. substrate according to claim 1, it is characterized in that: the freezing point of described substrate is 24 ℃-35 ℃, and fusing point is below 37 ℃.
3. the preparation method of substrate according to claim 1 is characterized in that: selected vegetable oil, low melting point adjuvant, high-melting-point adjuvant are mixed in proportion, and heating makes melting, stirs, and is incubated standby.
4. the preparation method of substrate according to claim 3, it is characterized in that: with the cooling rear storage of described substrate, heating and melting during use stirs, and is incubated in 40 ℃ of uses.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100481301A CN101513531B (en) | 2009-03-24 | 2009-03-24 | Soft capsule matrix and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100481301A CN101513531B (en) | 2009-03-24 | 2009-03-24 | Soft capsule matrix and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101513531A CN101513531A (en) | 2009-08-26 |
| CN101513531B true CN101513531B (en) | 2013-06-19 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009100481301A Active CN101513531B (en) | 2009-03-24 | 2009-03-24 | Soft capsule matrix and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101513531B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107495258A (en) * | 2017-08-28 | 2017-12-22 | 张家界供销云商股份有限公司 | A kind of honeybee product of beeswax parcel honey and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348364A (en) * | 1999-02-26 | 2002-05-08 | 盐野义制药株式会社 | Chewable soft capsules having improved administration properties and process for producing the same |
| CN1931306A (en) * | 2005-08-22 | 2007-03-21 | 杨文龙 | Chinese medicine soft capsule for treating urinary system diseases and its prepn process |
-
2009
- 2009-03-24 CN CN2009100481301A patent/CN101513531B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348364A (en) * | 1999-02-26 | 2002-05-08 | 盐野义制药株式会社 | Chewable soft capsules having improved administration properties and process for producing the same |
| CN1931306A (en) * | 2005-08-22 | 2007-03-21 | 杨文龙 | Chinese medicine soft capsule for treating urinary system diseases and its prepn process |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101513531A (en) | 2009-08-26 |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C53 | Correction of patent for invention or patent application | ||
| CB03 | Change of inventor or designer information |
Inventor after: Han Qinghui Inventor after: Zhang Lizhi Inventor after: Xuan Zhenyu Inventor after: Chen Yeming Inventor after: Wang Xiaohu Inventor after: Zou Shanshan Inventor after: Hua Yan Inventor before: Han Qinghui Inventor before: Xuan Zhenyu Inventor before: Chen Yeming Inventor before: Wang Xiaohu |
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| COR | Change of bibliographic data |
Free format text: CORRECT: INVENTOR; FROM: HAN QINGHUI XUAN ZHENYU CHEN YEMING WANG XIAOHU TO: HAN QINGHUI ZHANG LIZHI XUAN ZHENYU CHEN YEMING WANG XIAOHU ZOU SHANSHAN HUA YAN |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |