CN100431530C - Soft polyene phosphatidylcholinecapsule and its prepn process - Google Patents
Soft polyene phosphatidylcholinecapsule and its prepn process Download PDFInfo
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- CN100431530C CN100431530C CNB2006101043669A CN200610104366A CN100431530C CN 100431530 C CN100431530 C CN 100431530C CN B2006101043669 A CNB2006101043669 A CN B2006101043669A CN 200610104366 A CN200610104366 A CN 200610104366A CN 100431530 C CN100431530 C CN 100431530C
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Abstract
The present invention relates to soft polyene phosphatidylcholine capsule and its preparation process, and belongs to the field of medicine preparing technology. The preparation process include mixing polyene phosphatidylcholine in the recipe amount, vitamins and co-solvent, antioxidant under medicine GMP condition; adding supplementary material and mixing; sieving, subpacking, sealing, scrubbing capsule and air drying to obtain soft capsule. Encapsulating polyene phosphatidylcholine, which is easy to oxidize, sensitive to light and heat and unstable in water solution, can raise the stability of the medicine and reduce the stimulation to gastrointestinal tract.
Description
Technical field
The present invention relates to soft polyene phosphatidylcholinecandule and preparation method thereof, particularly relate to a kind of pharmaceutical preparation for the treatment of diseases such as polytype hepatopathy, cholestasis, poisoning, the recurrence of prevention cholelithiasis, gestosis, psoriasis, neurodermatitis, radiation syndrome and preparation method thereof, belong to field of medicine preparing technology.
Background technology
Hepatitis can be divided into many types because of pathogenetic difference, as viral hepatitis, drug induced hepatitis (toxic hepatitis), bacillary hepatitis etc.; But common people's said " hepatitis " refer to by first type, B-mode, third type, fourth type, the caused viral hepatitis of hepatitis E virus.Its clinical manifestation has all that infectiousness is strong, the course of disease is long and the big general character of hazardness, and the probability that changes into chronic hepatitis is also bigger.
China is populous nation, also is " hepatitis big country " simultaneously.The various hepatopaths of China are up to tens million of at present, and the hepatitis virus carrier is hundreds of millions of, and are annual because of the about hundreds of thousands people of the number of hepatopathy death.The task of preventing and treating of hepatopathy is very arduous.
The medicine of preventing and treating hepatopathy at present has a variety of, but good effect, the low medicine of side effect but seldom, especially all effectively broad-spectrum medicinal is just still less to various hepatopathys.The Main Ingredients and Appearance of polyene phosphatidylcholine is the essential phospholipid class, its chemical constitution is suitable with endogenous phospholipid, promptly exist the phospholipid of liver plasma membrane suitable with those, because of containing a large amount of polyunsaturated fatty acid, its function can be excellent than endogenous phospholipid, in vivo, mainly build up at liver, with the film system combination of whole molecule and liver plasma membrane and organelle thereof, the hepatocyte structure of destroyed is carried out the physiology reparation, created prerequisite for recovering normal liver function; It also has the adjusting immunologic process in addition, stablizes liver plasma membrane, suppresses the lipid peroxidation that free radical causes, the liver plasma membrane that damaged by the immunopathology process is recovered and stablizes; It is again biliary main emulsifying agent, can promote bile emulsifying to drain, so the effect that has promoting the function of the gallbladder to alleviate jaundice effect and prevention cholelithiasis to form; This series products is applied to acute clinically or chronic hepatitis, hepatic necrosis, liver cirrhosis, hepatic coma (comprising forerunner's hepatic coma); Fatty liver (also seeing the diabetes patient); Cholestasis; Poison; The prevention recurrence of hepatolithiasis; Perioperative treatment, especially hepatobiliary surgery; Also can be used to prevent the formation and the radiation treatment syndrome of cholelithiasis.
The polyene phosphatidylcholine dosage form of having used clinically at present has aqueous injection, hard capsule.Because the easy oxidation of polyene phosphatidylcholine, all responsive to light and heat, its properties of Aqueous Solution is difficult for stable, is to improve product stability, also provides new dosage form for clinical simultaneously, and the present invention proposes soft polyene phosphatidylcholinecandule and preparation method thereof.
Summary of the invention
The objective of the invention is to propose soft polyene phosphatidylcholinecandule and preparation method thereof, improve the medicine stability of polyene phosphatidylcholine and make soft capsule, better meet the clinical needs of medicine with this.
The soft polyene phosphatidylcholinecandule that the present invention proposes, prescription is as follows when 1000 soft capsules of preparation:
Polyene phosphatidylcholine 40.0g～700.0g
Vitamin 0.05g～3.0g
Cosolvent 20.0g～500.0g
Antioxidant 0.5g～15.0g
1-5.5mol/L HCl is an amount of
Soft capsule content adjuvant 80g～1000g
Soft capsule material is an amount of
The soft polyene phosphatidylcholinecandule always amount of making is 1000, contains polyene phosphatidylcholine 40.0mg～700.0mg in every soft capsule, and every soft capsule weighs 0.4～1.7g.
The preparation method of the soft polyene phosphatidylcholinecandule with above-mentioned prescription that the present invention proposes may further comprise the steps:
1, in the place that meets medicine GMP condition, polyene phosphatidylcholine, vitamin, cosolvent, the antioxidant of getting formula ratio place in the clean measurer, and mixing gets material A, and is standby.
2. in material A, add the soft capsule content adjuvant, the weight ratio of adding is: material A: soft capsule content adjuvant=1: 1.0～2.5, at 20 ℃～45 ℃ abundant mixings down, sieve, packing, seal, wipe capsule, air-dry soft capsule.
In the said method vitamin be vitamin B
1, vitamin B
2, vitamin B
6, vitamin B
12, in the Vitamin E acetate one or more mix and use.
In the said method vitamin, per 1000 amount ranges is: vitamin B
1: 0.01g～1.50g, vitamin B
2: 0.01g～1.50g, vitamin B
6: 0.01g～1.50g, vitamin B
12: 0.005g～1.250g, Vitamin E acetate: 0.005g～1.500g.
Cosolvent in the said method is that one or more mixing in sodium pantothenate, nicotiamide, poloxamer, deoxycholic acid or polyoxyethylene (40) or the Oleum Ricini are used.
In the said method antioxidant be that in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, the vitamin C one or more mix to use.
Used soft capsule content adjuvant is one or more mixing uses in Cera Chinensis, vegetable oil, Liquid Macrogol, PEG400, glycerol, the propylene glycol in the said method.
In the said method, material A and soft capsule content adjuvant weight ratio are: material A: soft capsule content adjuvant=1: 1.0～2.5.
The formulation ratio of the soft capsule material in the said method is:
Gelatin 0.8～1.2kg plasticizer 0.20～0.80kg
Antiseptic 0～5g ethanol 0～0.03L
Water 1.0～1.6kg TiO
21～15g
Plasticizer is a kind of in glycerol, the sorbitol or both mixture in the prescription of the soft capsule material in the said method.
Antiseptic is the mixture of methyl parahydroxybenzoate, propyl p-hydroxybenzoate in the prescription of the soft capsule material in the said method, and proportioning is methyl hydroxybenzoate 3-5 part, nipasol 1-3 part.
Soft polyene phosphatidylcholinecandule of the present invention and preparation method thereof studies show that through stability test stable preparation process is feasible.
Contain polyene phosphatidylcholine 40.0mg～700.0mg in every soft capsule in the said method, every soft capsule weighs 0.4～1.7g.
The characteristics and the advantage of the soft polyene phosphatidylcholinecandule of the inventive method preparation are as follows:
1, process stabilizing, science, advanced person.Because the easy oxidation of polyene phosphatidylcholine, all responsive to light and heat, its properties of Aqueous Solution is difficult for stable, has increased stability of drug after making soft capsule.
2, this dosage form plasticity is strong, elasticity is big, has reduced the stimulation to the intestines and stomach.
The specific embodiment
Embodiment one
Soft polyene phosphatidylcholinecandule specification: 40mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 40g, the deoxycholic acid of 45g places mixer, adds the 3ml0.1% sodium sulfite solution, behind the mix homogeneously, adds the 0.9mg vitamin B
2With the 1mg vitamin B
12, add behind the mixing 102g vegetable oil and Cera Chinensis mixture (wherein Cera Chinensis accounts for 6% of adjuvant, oil account for adjuvant 94%), abundant mixing under 35 ℃, regulate content pH value to 6.5 with 1mol/LHCl, cross 80 mesh sieves, packing under 35 ℃ of abundant stirring conditions, be encapsulated as soft capsule.Soft capsule material consists of: gelatin 1kg, glycerol 0.39kg, antiseptic 2g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning are 4 parts of methyl hydroxybenzoates, 1 part of nipasol), water 1kg, TiO
23g.Prepare 1000 of soft capsules altogether, every heavy 0.4g of soft capsule.
Embodiment two
Soft polyene phosphatidylcholinecandule specification: 77.5mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 77.5g, the deoxycholic acid of 60g places mixer, adds the 4ml0.1% sodium sulfite solution, behind the mix homogeneously, adds the 1.2mg vitamin B
2With the 2mg vitamin B
12, add behind the mixing 165g vegetable oil and Cera Chinensis mixture (wherein Cera Chinensis accounts for 6% of adjuvant, oil account for adjuvant 94%), abundant mixing under 35 ℃, regulate content pH value to 7.0 with 1mol/LHCl, cross 80 mesh sieves, packing under 35 ℃ of abundant stirring conditions, be encapsulated as soft capsule.Soft capsule material consists of: gelatin 1kg, glycerol 0.39kg, antiseptic 3g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning are 3 parts of methyl hydroxybenzoates, 1 part of nipasol), water 1kg, TiO
22g.Prepare 1000 of soft capsules altogether, every heavy 0.5g of soft capsule.
Embodiment three
Soft polyene phosphatidylcholinecandule specification: 155mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 155g, the deoxycholic acid of 70g places mixer, adds the 4.5ml0.1% sodium sulfite solution, behind the mix homogeneously, adds the 4mg vitamin B
2With the 3mg vitamin B
12, add behind the mixing 337.5g vegetable oil and Cera Chinensis mixture (wherein Cera Chinensis accounts for 2% of adjuvant, oil account for adjuvant 98%), abundant mixing under 40 ℃ is regulated content pH value to 5.5 with 1mol/L HCl, crosses 60 mesh sieves, under 40 ℃ of abundant stirring conditions, packing, be encapsulated as soft capsule.The capsule material of soft capsule consists of: gelatin 0.9kg, glycerol 0.31kg, the antiseptic 3.5g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning is 4 parts of methyl hydroxybenzoates, 1 part of nipasol), ethanol 0.02L, water 0.9kg, TiO
24g.Prepare 1000 of soft capsules altogether, every heavy 0.7g of soft capsule.
Embodiment four
Soft polyene phosphatidylcholinecandule specification: 155mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 250g, the poloxamer of 65g places mixer, adds the 5ml0.1% hypo solution, behind the mix homogeneously, adds the 1.5mg vitamin B
6With the 2mg vitamin B
12Mixture (the Liquid Macrogol wherein: PEG400=1: 0.5) that adds 787.5g Liquid Macrogol and PEG400 behind the mixing, abundant mixing under 35 ℃, regulate content pH value to 4.5 with 1mol/L HCl, cross 100 mesh sieves, under 35 ℃ of abundant stirring conditions, packing, be encapsulated as soft capsule.The capsule material of soft capsule consists of: gelatin 1.05kg, glycerol 0.28kg, ethanol 0.02L, water 1.10kg, TiO
25g.Prepare 1000 of soft capsules altogether, every heavy 1.5g of soft capsule.
Embodiment five
Soft polyene phosphatidylcholinecandule specification: 250mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 250g, the deoxycholic acid of 120g places mixer, adds the 5ml0.1% sodium sulfite solution, behind the mix homogeneously, adds the 3mg vitamin B
6With the 1.5mg vitamin B
12, add behind the mixing 372g vegetable oil and Cera Chinensis mixture (wherein Cera Chinensis accounts for 2% of adjuvant, oil account for adjuvant 98%), abundant mixing under 40 ℃ is regulated content pH value to 3.5 with 1mol/LHCl, crosses 60 mesh sieves, under 40 ℃ of abundant stirring conditions, packing, be encapsulated as soft capsule.The capsule material of soft capsule consists of: gelatin 1kg, glycerol 0.31kg, antiseptic 4g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning are 4 parts of methyl hydroxybenzoates, 1 part of nipasol), ethanol 0.01L, water 1kg, TiO
23.5g.Prepare 1000 of soft capsules altogether, every heavy 1g of soft capsule.
Embodiment six
Soft polyene phosphatidylcholinecandule specification: 310mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 310g, the polyoxyethylene of 220g (40) Oleum Ricini places mixer, adds the 5.5ml0.1% sodium sulfite solution, behind the mix homogeneously, adds the 1.8mg vitamin B
6With the 2.5mg vitamin B
12, add behind the mixing 689g vegetable oil and Cera Chinensis mixture (wherein Cera Chinensis accounts for 6% of adjuvant, oil account for adjuvant 94%), abundant mixing under 35 ℃, regulate content pH value to 6.5 with 1mol/L HCl, cross 80 mesh sieves, packing under 35 ℃ of abundant stirring conditions, be encapsulated as soft capsule.Soft capsule material consists of: gelatin 1.1kg, glycerol 0.39kg, the antiseptic 4g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning is 5 parts of methyl hydroxybenzoates, 1 part of nipasol), ethanol 0.018L, water 1.1kg, TiO
25g.Prepare 1000 of soft capsules altogether, every heavy 1.5g of soft capsule.
Embodiment seven
Soft polyene phosphatidylcholinecandule specification: 500mg/ grain (in polyene phosphatidylcholine)
Take by weighing the polyene phosphatidylcholine of 500g, the poloxamer of 60g places mixer, add 5g vitamin C mix homogeneously after, add the 1mg vitamin B
1, the 2mg vitamin B
2, the 0.5mg vitamin B
6, the 2mg vitamin B
12, the 2mg Vitamin E acetate, mixture (the Liquid Macrogol wherein: PEG400=1: 0.5) that adds 672g Liquid Macrogol and PEG400 behind the mixing, abundant mixing under 35 ℃, regulate content pH value to 7.0 with 1mol/L HCl, cross 100 mesh sieves, under 35 ℃ of abundant stirring conditions, packing, be encapsulated as soft capsule.The capsule material of soft capsule consists of: gelatin 0.8kg, glycerol 0.39kg, antiseptic 4.5g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning are 5 parts of methyl hydroxybenzoates, 1 part of nipasol), water 0.8kg, TiO
25g.Prepare 1000 of soft capsules altogether, every heavy 1.5g of soft capsule.
Embodiment eight
Soft polyene phosphatidylcholinecandule specification: 700mg/ grain (in polyene phosphatidylcholine)
The poloxamer that takes by weighing the polyene phosphatidylcholine of 700g places mixer, adds the 6ml0.1% sodium sulfite solution, behind the mix homogeneously, adds the 15mg vitamin B
2With the 4mg vitamin B
12, add behind the mixing 720g vegetable oil and Cera Chinensis mixture (wherein Cera Chinensis accounts for 2% of adjuvant, oil account for adjuvant 98%), abundant mixing under 40 ℃ is regulated content pH value to 7.0 with 1mol/L HCl, crosses 60 mesh sieves, under 40 ℃ of abundant stirring conditions, packing, be encapsulated as soft capsule.The capsule material of soft capsule consists of: gelatin 1.1kg, glycerol 0.31kg, the antiseptic 5g (mixture of methyl hydroxybenzoate, propyl p-hydroxybenzoate, proportioning is 5 parts of methyl hydroxybenzoates, 1 part of nipasol), ethanol 0.02L, water 1.1kg, TiO
20.09 ‰.Prepare 1000 of soft capsules altogether, every heavy 1.7g of soft capsule.
Claims (2)
1, a kind of soft polyene phosphatidylcholinecandule is characterized in that this soft capsule prescription consists of:
Polyene phosphatidylcholine 40.0g～700.0g
Vitamin 0.05g～3.0g
Cosolvent 20.0g～500.0g
Antioxidant 0.5g～15.0g
1-5.5mol/L HCl is an amount of
Soft capsule content adjuvant 80g-1000g
Soft capsule material is an amount of
The soft polyene phosphatidylcholinecandule always amount of making is 1000, contains polyene phosphatidylcholine 40.0mg～700.0mg in every soft capsule, and every soft capsule weighs 0.4～1.7g.
Said vitamin is a vitamin B
1, vitamin B
2, vitamin B
6, vitamin B
12, in the Vitamin E acetate one or more mix and use.
Above-mentioned cosolvent is that one or more mixing in sodium pantothenate, nicotiamide, poloxamer, deoxycholic acid or polyoxyethylene (40) Oleum Ricini are used.
Above-mentioned antioxidant is that one or more mixing in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate or the vitamin C are used
Above-mentioned soft capsule content adjuvant is that one or more mixing in Cera Chinensis, vegetable oil, Liquid Macrogol, PEG400, glycerol, the propylene glycol are used.
The prescription of above-mentioned soft capsule material is:
Gelatin 0.8～1.2kg plasticizer 0.20～0.80kg
Antiseptic 0～5g ethanol 0～0.03L
Water 1.0～1.6kg TiO
21～15g
2, a kind of preparation method of soft polyene phosphatidylcholinecandule, prescription is when it is characterized in that in this soft capsule being preparation amount with 1000:
Polyene phosphatidylcholine 40.0g～700.0g
Vitamin 0.05g～3.0g
Cosolvent 20.0g～500.0g
Antioxidant 0.5g～15.0g
1-5.5mol/L HCl is an amount of
The soft capsule content right amount of auxiliary materials
Soft capsule material is an amount of
The soft polyene phosphatidylcholinecandule always amount of making is 1000, contains polyene phosphatidylcholine 40.0mg～700.0mg in every soft capsule, and every soft capsule weighs 0.4～1.7g.
Preparation method may further comprise the steps:
(1), in the place that meets medicine GMP condition, polyene phosphatidylcholine, vitamin, cosolvent, the antioxidant of getting formula ratio place in the clean measurer, mixing gets material A, and is standby.
(2). in material A, add the soft capsule content adjuvant, the weight ratio of adding is: material A: soft capsule content adjuvant=1: 1.0～2.5, abundant mixing under 20 ℃～45 ℃, regulate pH value with 1-5.5mol/L HCl, sieve, packing, seal, wipe capsule, air-dry soft capsule.
Vitamin is a vitamin B in the said method
1, vitamin B
2, vitamin B
6, vitamin B
12, in the Vitamin E acetate one or more mix and use.
The vitamin amount ranges is in the above-mentioned steps: vitamin B
1: 0.01g～1.50g, vitamin B
2: 0.01g～1.50g, vitamin B
6: 0.01g～1.50g, vitamin B
12: 0.005g～1.250g, Vitamin E acetate: 0.005g～1.500g.
Cosolvent is one or more mixing uses in sodium pantothenate, nicotiamide, poloxamer, deoxycholic acid or polyoxyethylene (40) Oleum Ricini in the above-mentioned steps.
Antioxidant is one or more mixing uses in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate or the vitamin C in the above-mentioned steps.
The soft capsule content adjuvant is one or more mixing uses in Cera Chinensis, vegetable oil, Liquid Macrogol, PEG400, glycerol, the propylene glycol in the above-mentioned steps.
The prescription of soft capsule material is in the above-mentioned steps:
Gelatin 0.8～1.2kg plasticizer 0.20～0.80kg
Antiseptic 0～5g ethanol 0～0.03L
Water 1.0～1.6kg TiO
21～15g
Plasticizer in the above-mentioned capsule material formula is a kind of in glycerol, the sorbitol or both mixture.
Antiseptic in the above-mentioned capsule material formula is the mixture of methyl parahydroxybenzoate, propyl p-hydroxybenzoate, and proportioning is methyl hydroxybenzoate 3-5 part, nipasol 1-3 part.
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101045062B (en) * | 2007-02-04 | 2011-07-27 | 杨喜鸿 | Polyenephophatidylcholine enteric coated preparation, its preparing method and application |
| CN101756907B (en) * | 2009-03-13 | 2011-08-31 | 北京瑞伊人科技发展有限公司 | Preparation method of oral solid preparation containing polyene phosphatidyl choline |
| CN103202849A (en) * | 2012-01-12 | 2013-07-17 | 苏州九龙医院有限公司 | New use of polyene phosphatidyl choline medicine in treatment of obesity and insulin resistance syndromes (metabolic syndromes) |
| CN103908440B (en) * | 2013-01-09 | 2016-12-28 | 正大天晴药业集团股份有限公司 | A kind of polyene phosphatidylcholine capsule and preparation method thereof |
| CN106606780B (en) * | 2015-10-26 | 2020-05-19 | 深圳澳美制药技术开发有限公司 | Polyene phosphatidyl choline composition, soft capsule and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1518987A (en) * | 2000-06-02 | 2004-08-11 | 大连万友贸易有限公司 | Now usage of polyunsaturated phosphatidylcholine |
| CN1781488A (en) * | 2005-10-08 | 2006-06-07 | 许群 | Polyene phosphatidyl choline infusion solution and its preparing method |
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2006
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1518987A (en) * | 2000-06-02 | 2004-08-11 | 大连万友贸易有限公司 | Now usage of polyunsaturated phosphatidylcholine |
| CN1781488A (en) * | 2005-10-08 | 2006-06-07 | 许群 | Polyene phosphatidyl choline infusion solution and its preparing method |
Non-Patent Citations (2)
| Title |
|---|
| 药剂学. 毕殿洲 主编，第303－305页，人民卫生出版社. 2000 |
| 药剂学. 毕殿洲 主编，第303－305页，人民卫生出版社. 2000 * |
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Effective date of registration: 20190930 Address after: 102200 Room 101, building 9, yard 8, Heying Road, Nanshao Town, Changping District, Beijing Patentee after: Guoren health pharmaceutical (Beijing) Co., Ltd. Address before: 100027, room 18, 1-1608 Xin Tong Street, Beijing, Dongcheng District Patentee before: Beijing Guorentang Medical Science Developing Co., Ltd. |