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Injecting medicine composition for improving stability of ginsenoside medicine injection

A ginsenoside and injection preparation technology, applied in the field of medicine, can solve the problems of inconvenient clinical medication and promotion, easy rancidity, high risk of clinical application of injection, and achieve convenient clinical medication and promotion, stable pH value of medicinal solution, and reduction of degradable substances. Effect

Inactive Publication Date: 2016-10-12
成都市斯贝佳科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because polysorbate 80 has hemolysis and hypotensive effects, and is prone to rancidity during storage and high-temperature sterilization, the risk of clinical application of injections containing polysorbate 80 is relatively high, which brings inconvenience to clinical medication and promotion.

Method used

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  • Injecting medicine composition for improving stability of ginsenoside medicine injection
  • Injecting medicine composition for improving stability of ginsenoside medicine injection
  • Injecting medicine composition for improving stability of ginsenoside medicine injection

Examples

Experimental program
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Effect test

Embodiment 1

[0024] A method for preparing a pharmaceutical composition for injection that improves the stability of ginsenoside drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug calculated as ginsenoside, 9.0 g of sodium chloride, and 1 mg to 2.0 g of sodium citrate and 1 mg to 2.0 g of sodium citrate; (2) citric acid and sodium citrate were prepared into 10% to 20% solutions for later use. (3) Add to 500ml of water for injection below 40°C, stir until completely dissolved, then add 0.02% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize. (4) Use citric acid or sodium citrate solution to adjust the pH of the filtrate to 3.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0025] The specific components and contents thereof of the present embodiment are as follows:

[0026]

[0027] Citric acid and sodium citrate were pre...

Embodiment 2

[0029] Alternatively, the pharmaceutical composition for injection that improves the stability of the ginsenoside drug injection preparation is prepared according to the following steps:

[0030] (1) Weigh 0.1g-100g of raw material medicine calculated as ginsenoside, 1mg-2.0g of citric acid, 1mg-2.0g of sodium citrate; (2) prepare 10% of citric acid and sodium citrate respectively ~20% solution, set aside. (3) Add to 500ml of water for injection below 40°C, stir until completely dissolved, then add 0.02% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize. (4) Use citric acid or sodium citrate solution to adjust the pH of the filtrate to 3.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0031] The specific components and contents thereof of the present embodiment are as follows:

[0032] Ginsenoside Hydrochloride 20g

[0033] Citric acid 1.0g

[0034] Sodium citrate 2.0g...

Embodiment 3

[0037] Comparative Test of Stability of Ginsenoside Sodium Chloride Injection

[0038] The detection of visible foreign matter of the ginsenoside sodium chloride injection prepared by the present invention complies with the provisions of the drug quality standard, and the stability of the solution is very good. In the case of avoiding the use of other co-solvents that increase the risk of clinical application, the ginsenoside solution is solved. Sodium chloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the ginsenoside sodium chloride injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC drug preparation stability test guiding principle, respectively inspected 24 months at 25 ℃, 6 at 40 ℃ The stability of the drug can be obtained by placing it at 60°C for 10 days, and at 0-5°C for 20 days. The results show that the pro...

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Abstract

The invention discloses an injecting medicine composition for improving the stability of a ginsenoside medicine injection and a preparation method thereof. The preparation method mainly comprises the following steps: dissolving salt of ginsenoside in injecting water; adding citric acid and / or sodium citrate to serve as a pH regulator, and regulating the pH value of the medicinal liquid, wherein the dosage of the citric acid and / or sodium citrate is 0.1-200.0mg / 100ml. By adopting the preparation method, the pH value of the injection can be stable, the ginsenoside degraded substances are greatly reduced in comparison with that in the prior art, the clarity of ginsenoside injection is improved under a condition that other cosolvent capable of increasing clinical application risks is prevented from being used, and the problems that the ginsenoside injection has small spots, white blocks and turbid solution by adopting the prior art under a condition of long storage period can be especially solved, obviously foreign matter inspection of the injection accords with the specification of medicine quality standard, and clinical medication and popularization can be benefited.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for injection that improves the stability of ginsenoside drug injection preparations. Background technique [0002] Ginsenoside is a kind of sterol compound, triterpene saponin. It is mainly found in ginseng medicinal materials. Ginsenosides are considered to be the active ingredients in ginseng and thus have been the subject of research. Because ginsenosides affect multiple metabolic pathways, their efficacy is also complex, and the monomeric components of various ginsenosides are difficult to separate. The wild plant, the sky fruit, which grows in the South Pacific Islands, also contains ginsenosides, which have a wide range of medicinal effects. [0003] Since ginsenosides have very poor solubility in aqueous solutions, they are made into ginsenoside hydrochloride or ginsenoside phosphate to increase their water solubility. Current...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K9/08A61K36/258
CPCA61K47/12A61K9/0019A61K9/08A61K36/258
Inventor 杨素坤
Owner 成都市斯贝佳科技有限公司
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