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Preparation method of drug composition for improving stability of Shengmai drug injection preparation

An injection preparation and stability technology, which is applied in the field of preparation of pharmaceutical compositions to improve the stability of Shenmai drug injection preparations, can solve the problems of easy rancidity, high risk of clinical application of injections, inconvenience in clinical medication and promotion, etc., and achieve pH value Stable, convenient for clinical use and promotion, and the effect of reducing degradation substances of ginseng and wheat

Inactive Publication Date: 2017-02-01
CHENGDU XIANXIANXIAN BIOTECH CO LTD
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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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  • Preparation method of drug composition for improving stability of Shengmai drug injection preparation
  • Preparation method of drug composition for improving stability of Shengmai drug injection preparation
  • Preparation method of drug composition for improving stability of Shengmai drug injection preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0025] A method for preparing a pharmaceutical composition for improving the stability of Shenmai drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of raw materials based on Shen Mai, 9.0 g of sodium chloride, and 1 mg to 2.0 g of oxalic acid , Sodium oxalate 1mg~2.0g; (2) Oxalic acid and sodium oxalate are prepared into 10%~20% solutions respectively, and 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) Adjust the pH value of the filtrate to 3.0-7.0 with oxalic acid or sodium oxalate solution, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0026] The specific components and contents thereof of the present embodiment are as follows:

[0027]

[0028] Oxalic acid and sodium oxalate were prepared into 10% to 20% solutions r...

Embodiment 2

[0030] Alternatively, the above pharmaceutical composition for injection that improves the stability of the Shenmai drug injection preparation is prepared according to the following steps:

[0031] (1) Weigh 0.1g-100g of the raw material medicine, 1mg-2.0g of oxalic acid, and 1mg-2.0g of sodium oxalate; (2) Prepare 10%-20% solutions of oxalic acid and sodium oxalate respectively 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) Adjust the pH value of the filtrate to 3.0-7.0 with oxalic acid or sodium oxalate solution, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0032] The specific components and contents thereof of the present embodiment are as follows:

[0033] ginseng hydrochloride 20g

[0034] Oxalic acid 1.0g

[0035] Sodium oxalate 2.0g

[0036] Oxa...

Embodiment 3

[0038] Comparative Test of Stability of Shenmai Sodium Chloride Injection

[0039] The detection of visible foreign matter in the Shenmai 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 problem of Shenmai sodium chloride injection is solved. Sodium chloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. The Shenmai Sodium Chloride Injection prepared by utilizing the present invention was investigated respectively in 24 months at 25°C and 6 at 40°C according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix XIXC pharmaceutical preparation stability test guidelines. 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....

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Abstract

The invention discloses a preparation method of a drug composition for improving the stability of a Shengmai drug injection preparation. The drug composition for injection is mainly prepared by dissolving Shengmai salt in water for injection and adding oxalic acid and / or sodium oxalate to serve as a pH regulator for regulating a pH value of medicinal liquid. The usage amount of the oxalic acid and / or sodium oxalate is 1-100.0 mg / 100ml. The pH value of the injection can be stable, substance degradability of the Shengmai is greatly reduced compared with the prior art, the clarity of the Shengmai injection is improved under the situation that other cosolvents increasing clinical application risks are not used, especially the problem that the Shengmai injection adopting a product in the prior art produces small white points, white blocks and is turbid under the condition of long storage time is solved, and it can be ensured that visible foreign matter inspection of the product meets the stipulations of the drug quality standard and the drug composition is convenient to clinically apply and popularize.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a pharmaceutical composition for improving the stability of Shenmai drug injection preparations. Background technique [0002] Shenmai is an alkaloid extracted from the traditional Chinese medicine Chuanxiong. Its chemical structure is tetramethylpyrazine. It is a new type of calcium ion antagonist. And bronchial smooth muscle, improve microcirculation and other functions, clinically used for occlusive cerebrovascular diseases such as cerebral insufficiency, cerebral thrombosis, cerebral embolism and other ischemic vascular diseases such as coronary heart disease, vasculitis, etc. Shenmai injection has made a great contribution to the treatment of modern difficult diseases with traditional Chinese medicine. [0003] Since sammai has very poor solubility in aqueous solution, it is made into shenmai hydrochloride or shenmai phosphate to increas...

Claims

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Application Information

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IPC IPC(8): A61K36/8968A61K9/08A61K47/12A61P9/10A61P7/02
CPCA61K36/8968A61K9/0019A61K9/08A61K36/258A61K47/12A61K2300/00
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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