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Soft polyene phosphatidylcholinecapsule and its prepn process

A polyene phosphatidylcholine and soft capsule technology, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations containing active ingredients, can solve problems such as drugs with low side effects, achieve high elasticity, reduce irritation, and stabilize the preparation process workable effect

Active Publication Date: 2007-01-03
国仁健康制药(北京)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are many kinds of drugs for the prevention and treatment of liver diseases, but there are few drugs with good curative effect and low side effects, especially the broad-spectrum drugs that are effective for various liver diseases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Polyene Phosphatidylcholine Soft Capsule Specification: 40mg / capsule (calculated as polyene phosphatidylcholine)

[0038] Weigh 40g of polyene phosphatidylcholine and 45g of deoxycholic acid into the batching bucket, add 3ml of 0.1% sodium sulfite solution, mix well, add 0.9mg of vitamin B 2 and 1mg vitamin B 12 After mixing, add the mixture of 102g vegetable oil and paraffin (wherein paraffin accounts for 6% of the auxiliary material, and oil accounts for 94% of the auxiliary material), fully mix at 35°C, adjust the pH value of the content to 6.5 with 1mol / L HCl, Pass through a 80-mesh sieve, sub-package and encapsulate into soft capsules under the condition of sufficient stirring at 35°C. The capsule material of the soft capsule is composed of: gelatin 1kg, glycerin 0.39kg, preservative 2g (a mixture of methylparaben and propylparaben, the proportion is 4 parts of methylparaben, 1 part of propylparaben parts), water 1kg, TiO 2 3g. Prepare 1000 soft capsules altoge...

Embodiment 2

[0040] Polyene Phosphatidylcholine Soft Capsule Specification: 77.5mg / capsule (calculated as polyene phosphatidylcholine)

[0041] Weigh 77.5g of polyene phosphatidylcholine and 60g of deoxycholic acid into the batching bucket, add 4ml of 0.1% sodium sulfite solution, mix well, add 1.2mg of vitamin B 2 and 2mg vitamin B 12 After mixing, add the mixture of 165g vegetable oil and paraffin wax (wherein paraffin wax accounts for 6% of the auxiliary material, and oil accounts for 94% of the auxiliary material), fully mix at 35°C, adjust the pH value of the content to 7.0 with 1mol / L HCl, Pass through a 80-mesh sieve, sub-package and encapsulate into soft capsules under the condition of sufficient stirring at 35°C. The capsule material of the soft capsule is composed of: gelatin 1kg, glycerin 0.39kg, preservative 3g (a mixture of methylparaben and propylparaben, the proportion is 3 parts of methylparaben, 1 part of propylparaben parts), water 1kg, TiO 2 2g. Prepare 1000 soft cap...

Embodiment 3

[0043] Polyene Phosphatidylcholine Soft Capsule Specification: 155mg / capsule (calculated as polyene phosphatidylcholine)

[0044] Weigh 155g of polyene phosphatidylcholine and 70g of deoxycholic acid into the batching bucket, add 4.5ml of 0.1% sodium sulfite solution, mix well, add 4mg of vitamin B 2 and 3mg vitamin B 12After mixing, add the mixture of 337.5g vegetable oil and pyrethrum (wherein pyrethrum accounts for 2% of the auxiliary materials, and oil accounts for 98% of the auxiliary materials), fully mix at 40°C, adjust the pH value of the contents to 5.5 with 1mol / L HCl , through a 60-mesh sieve, under the condition of full stirring at 40°C, sub-package and encapsulate into soft capsules. The capsule material of the soft capsule is composed of: gelatin 0.9kg, glycerin 0.31kg, preservative 3.5g (a mixture of methyl hydroxybenzoate and propyl p-hydroxybenzoate, the proportion is 4 parts of methyl hydroxybenzoate, hydroxybenzoic acid Propyl ester 1 part), ethanol 0.02L,...

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PUM

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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 [0001] The invention relates to polyene phosphatidylcholine soft capsules and a preparation method thereof, in particular to a method for treating various types of liver diseases, bile obstruction, poisoning, prevention of recurrence of gallstones, pregnancy poisoning, psoriasis, neurodermatitis, radiation A pharmaceutical preparation for diseases such as syndrome and a preparation method thereof belong to the technical field of pharmaceutical preparation. Background technique [0002] Hepatitis can be divided into many types due to different pathogenesis, such as viral hepatitis, drug-induced hepatitis (toxic hepatitis), bacterial hepatitis, etc.; , Viral hepatitis caused by hepatitis C, D, and E viruses. Its clinical manifestations all have the common characteristics of strong infectivity, long course of disease and great harm, and the probability of transforming into chronic hepatitis is also relatively high. [0003] my country is a country with a large...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/685A61K31/714A61K31/51A61K31/525A61K31/4415A61P1/16
Inventor 许馨文
Owner 国仁健康制药(北京)有限公司
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