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Polyene phosphatidyl choline powder injection and its preparation method

A technology of polyene phosphatidylcholine and powder injection, which is applied in antiviral agents, powder delivery, digestive system, etc., can solve the problems of drugs with low side effects, and achieve a stable and feasible preparation process

Inactive Publication Date: 2006-10-04
AOLING BODA MEDICINE SCI & TECH DEV BEIJING
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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

[0029] Weigh 50g of deoxycholic acid, add it to 1 / 5 of the water for injection, add 2mol / L NaOH to dissolve it while stirring, then accurately weigh 77.5g of polyene phosphatidylcholine, 3ml of 0.1% sodium sulfite solution , added to the above solution, stirred to disperse it evenly, then adjusted the pH value to 8.0±0.1 with 2mol / L hydrochloric acid, added the prescribed amount of dextran 20, nicotinamide, sodium pantothenate, and water for injection to the full amount, and added activated carbon Coarse filtration to obtain the crude filtrate, then add the prescribed amount of vitamin B 2 and vitamin B 12 The intermediate product is obtained, and the content of the intermediate product is determined. After passing the test, filter it with a 0.2um filter membrane, pack it into ampoules, 3ml / bottle, routinely freeze-dry, and pack it after passing the sampling inspection.

Embodiment 2

[0031] Take by weighing 140g of deoxycholic acid, add in 4 / 5 water for injection, add 5mol / L NaOH while stirring to make it dissolve, then accurately weigh 250g of polyene phosphatidylcholine, 5ml0.1% sodium sulfite solution, Add it into the above solution, stir to disperse it evenly, then adjust the pH value to 8.6±0.1 with 5mol / L hydrochloric acid, add the prescribed amount of mannitol, nicotinamide, sodium pantothenate, add water for injection to the full amount, add activated carbon crude Filter to get the crude filtrate, then add the vitamin B of prescription amount 2 and vitamin B 12 The intermediate product is obtained, and the content of the intermediate product is determined. After passing the test, filter it with a 0.25um filter membrane, pack it into ampoules, 3ml / bottle, routinely freeze-dry, and pack it after passing the sampling inspection.

Embodiment 3

[0033] Weigh 420g of deoxycholic acid, add it to 4 / 5 water for injection, add 5mol / L NaOH to dissolve it while stirring, then accurately weigh 697.5g of polyene phosphatidylcholine, 6ml of 0.1% sulfurous acid Add sodium hydrogen solution to the above solution, stir to disperse it evenly, then adjust the pH value to 9.0±0.1 with 4mol / L hydrochloric acid, add the prescribed amount of dextran 60, nicotinamide, and sodium pantothenate, and add water for injection to the full amount , add activated carbon to get the crude filtrate, and then add the prescribed amount of vitamin B 2 and vitamin B 12 The intermediate product is obtained, and the content of the intermediate product is determined. After passing the test, filter it with a 0.45um filter membrane, pack it into ampoules, 3ml / bottle, routinely freeze-dry, and pack it after passing the sampling inspection.

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Abstract

The invention relates to a freeze-dried powder injection of polyene phosphatidyl choline and its preparation, which comprises charging into a finite amount of water for injection by auxiliary solvent, pH regulator, polyene phosphatidyl choline, anti-oxidant agent, homogenizing through stirring, adjusting pH to 7.0-10.0, charging right amount of excipient, auxiliary solvent, and water for injection, charging activated charcoal and vitamins to obtain intermediate products, filtering with filter membrane and split charging.

Description

technical field [0001] The present invention relates to polyene phosphatidylcholine powder injection and 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 wit...

Claims

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Application Information

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IPC IPC(8): A61K31/6615A61K9/14A61P1/16A61P31/14A61P31/20
Inventor 庄洪波
Owner AOLING BODA MEDICINE SCI & TECH DEV BEIJING
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