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Method for increasing solubility of parabuxinidine-D injection

A technology of cyclovir buxus and injection preparations, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problems of low yield of finished products, high cost, complicated process, etc. , to achieve the effect of high yield, low cost and simple process

Inactive Publication Date: 2003-11-19
郭曙平
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this way, the whole process is complicated, tedious, with many steps, and the yield of finished products is low, resulting in high cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Embodiment 1: the preparation of Huowei Buxuxin D Injection

[0013] Take 0.5g of cyclovir buxicine D, add it to the 0.265g citric acid solution prepared in advance with water for injection, stir and dissolve it, then add water for injection to 800ml, measure the pH value, and adjust the pH with 0.1M citric acid solution The value is between 2.5 and 4.5; add about 0.2% activated carbon for needles, stir evenly; keep warm for 30 minutes, clarify and filter, add water for injection to the filtrate to 1000ml; sterilize and filter, pack in 1ml ampoules, and store at 100°C Sterilize at high temperature for 30 minutes to obtain cyclovirbuxuxin D injection preparation. Cyclovitamin D has a solubility of 100% in acidic aqueous solution.

Embodiment 2

[0014] Embodiment 2: the preparation of Huowei Buxuxin D powder injection

[0015] Take 0.5g of Cycloviral Buxus D, add 0.265g of citric acid, mix evenly, gradually add 2000g of mannitol according to the method of equal volume increasing mixing, mix evenly, aseptically pack in vials, seal, and make powder injection .

Embodiment 3

[0016] Example 3: Preparation of Cyclovitamin D Freeze-dried Injection

[0017] Take 0.5g of citric acid solution prepared in advance with water for injection, and add 0.5g of cyclovir buxaxin D to dissolve it; then add water for injection to about 800ml, measure the pH value, and adjust the pH value with 0.1M citric acid solution Between 2.5 and 6.5; add 20g of mannitol and 0.2% activated carbon for needles, stir to dissolve and mix, keep warm for 30 minutes, the temperature is ℃, clarify and filter; then add water for injection to 1000ml, sterilize and filter, and pack Put it in a 10ml vial; put it into the drying box of a freeze dryer that has been pre-frozen to -45°C, and pre-freeze for 2 hours; then vacuumize and reach 0.013KPa; heat the shelf to increase the temperature by 2-4°C per hour ;When the temperature of the shelf rises to 0°C and about 5% of the moisture in the product remains, the temperature can be raised rapidly, and the temperature can be increased by 4-10°C...

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PUM

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Abstract

A method for improving the solubility of cyclovirobuxine D injection in the form of liquid, freeze dried injection, sodium chloride injection, or glucose injection is prepared through mixing cyclovirobuxine D with acidic substance, adding excipient to obtain powder, holding pH value to 1-6.5, and stirring. Its advantages are high solubility in acidic solution (up to 100%), low cost and high curative effect.

Description

technical field [0001] The invention relates to a processing method for increasing the water solubility of cyclovir buxicine D injection preparation in the preparation process. Background technique [0002] Before the present invention was made, Cyclovirubuxin D was an alkaloid drug with good therapeutic effect and effect on cardiovascular diseases, and had been widely used. However, the solubility of cycloviral buxicine D in water is low. Because of this, cycloviral buxicine D drugs are made into oral medicines, which are absorbed into the blood by the human body, resulting in lower bioavailability than injection medicines. In order to solve this problem, in the prior art, the inorganic salt of cyclovirbuxusin D is prepared first, that is, the salt-forming reaction, after the solution is concentrated or added with an organic solvent to make it crystallize, purified and refined, the content is determined, and then used for injection Preparation of formulations. Like this, ...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61K47/12A61P9/10
Inventor 郭曙平
Owner 郭曙平
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