Preparation methods of potassium sodium dehydroandroan drographolide succinate and freeze-dried powder injection thereof

A technology of freeze-dried powder injection and Yanhuning, which is applied in the field of preparation of Yanhuning and its freeze-dried powder injection, and can solve the problems of high water content, ring splitting reaction of Yanhuning, low yield of raw materials of Yanhuning, etc. , to achieve the effect of enhancing curative effect, increasing content, improving curative effect and safety

Inactive Publication Date: 2010-07-21
HAINAN STAR PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the above-mentioned preparation method, because the local alkalinity is too large, ester decomposition and ring splitting reaction may occur in Yanhuning, and drying under reduced pressure may make the water content higher, so that the obtained Yanhuning raw materials are not as good as the appearance and solution color. , especially related substances, which do not meet the quality standards, will greatly increase the risk of adverse reactions such as allergies during use, and the yield of Yanhuning raw materials is also relatively low

Method used

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  • Preparation methods of potassium sodium dehydroandroan drographolide succinate and freeze-dried powder injection thereof
  • Preparation methods of potassium sodium dehydroandroan drographolide succinate and freeze-dried powder injection thereof
  • Preparation methods of potassium sodium dehydroandroan drographolide succinate and freeze-dried powder injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1, the preparation of Yanhuning

[0044] Dissolve 5 g of sodium hydroxide in 625 ml of water for injection to obtain a sodium hydroxide solution with a concentration of 0.2 mol / L for subsequent use. Dissolve 70g of Chuanhuning (Chengdu Tiantaishan Pharmaceutical Co., Ltd., H51023411) in 375ml of water for injection, add the above sodium hydroxide solution under stirring, and adjust the pH to 7.3. Then add activated carbon with 0.1% of the solution mass, stir at room temperature for 20 min, pass through a 0.45 μm microporous membrane for coarse filtration, then pass through a 0.22 μm microporous membrane for fine filtration, and freeze-dry the filtrate to obtain a light yellow powder. It is Yanhuning.

[0045] Freeze-drying according to the freeze-drying curve figure 2 operate:

[0046] The first stage of pre-freezing: using the slow freezing method, the temperature of the product is linearly lowered from 20°C to -45°C in 3 hours, and kept at -45°C for 2 h...

Embodiment 2

[0055] Example 2, the preparation of Yanhuning freeze-dried powder injection with a specification of 40 mg

[0056] according to figure 1 The preparation process for preparing Yanhuning freeze-dried powder injection is as follows: add 1600ml of water for injection into the liquid mixing tank, start stirring, and control the temperature of the liquid mixing tank at 45-55°C. Accurately weigh 40g of Yanhuning, add it into the above-mentioned dosing pot and stir until dissolved. Accurately weigh 10 g of sodium chloride, dissolve it in 200 ml of water for injection, and add it to the above-mentioned liquid mixing tank. After stirring the solution in the liquid mixing tank evenly, add 0.1% activated carbon for needles of the solution mass, stir and reflux for 15 minutes, adjust the pH value of the medicinal solution to 6.4 to 6.8 with 0.1 to 0.2 mol / L hydrochloric acid solution, and then use Make up to 2000ml with water for injection. Decarburization by filtration, followed by fi...

Embodiment 3

[0067] Example 3, the preparation of Yanhuning freeze-dried powder injection with a specification of 80mg

[0068] Add 1600ml of water for injection into the dosing tank, start stirring, and control the temperature of the dosing tank at 45-55°C. Accurately weigh 80g of Yanhuning, add it into the above-mentioned dosing pot and stir until dissolved. Accurately weigh 20g of sodium chloride, dissolve it in 200ml of water for injection, and add it to the above-mentioned liquid mixing tank. After stirring the solution in the liquid mixing tank evenly, add 0.1% activated carbon for needles of the solution mass, stir and reflux for 15 minutes, adjust the pH value of the medicinal solution to 6.4 to 6.8 with 0.1 to 0.2 mol / L hydrochloric acid solution, and then use Make up to 2000ml with water for injection. Decarburization by filtration, followed by filtration with a 0.22 μm microporous membrane, ultrafiltration with an ultrafiltration membrane with a molecular cut-off of 10,000, an...

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Abstract

The invention discloses preparation methods of potassium sodium dehydroandroan drographolide succinate and a freeze-dried powder injection thereof. The preparation method of potassium sodium dehydroandroan drographolide succinate comprises the following steps: dissolving potassium dehydroandrograpolide succinate into water for injection with mass being 4-5 times the mass of potassium dehydroandrograpolide succinate, then adjusting the pH value between 7.1-7.5 with 0.1-0.2mol / L of sodium hydroxide solution; and then adding activated carbon to remove the impurities, sequentially using a 0.45mu m microfiltration membrane and a 0.22mu m microfiltration membrane for filtration, collecting the filtrate and freeze drying the filtrate, thus obtaining potassium sodium dehydroandroan drographolide succinate. The preparation method of the freeze-dried powder injection of potassium sodium dehydroandroan drographolide succinate comprises the following steps: dissolving potassium sodium dehydroandroan drographolide succinate and sodium chloride into water for injection at 45-60 DEG C, adding activated carbon for needle with mass being 0.1% of the mass of the solution after uniform mixing, controlling the pH value of the solution between 6.4-6.8, replenishing the water for injection to the required amount; and carrying out filtration for decarbonization, then using a 0.22mu m microfiltration membrane for filtration, using an ultrafiltration membrane with cut-off molecular weight being 10000 dalton and then using the 0.22mu m microfiltration membrane for filtration, collecting the filtrate and freeze drying the filtrate, thus obtaining the freeze-dried powder injection of potassium sodium dehydroandroan drographolide succinate.

Description

[0001] This application is a divisional application with an application number of 200810106051.7, an application date of May 8, 2008, and an invention titled "Yanhuning and its preparation method for freeze-dried powder injection". technical field [0002] The invention relates to a preparation method of Yanhuning and its freeze-dried powder injection. Background technique [0003] Yanhuning, its chemical name is: 14-dehydroxy-11,12-didehydroandrographolide-3,19-disuccinic acid half ester potassium sodium salt, and its molecular formula is: C 28 h 34 KNaO 10 ·H 2 O, the structural formula is as shown in formula (I); It is dehydrated andrographolide half ester potassium sodium salt of succinate made from the diterpene compound andrographolide extracted from the traditional Chinese medicine Andrographis paniculata through structural transformation, which has antibacterial, detoxification, Anti-inflammatory effect. [0004] [0005] Formula (I) [0006] Yanhuning can in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/365A61K47/02A61P29/00A61P31/04A61P31/12C07D307/58
Inventor 张煜范建飞周庆柱
Owner HAINAN STAR PHARM CO LTD
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