Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition

An injection preparation, Ligustrazine technology, applied in the field of medicine, can solve the problems of easy rancidity, inconvenient clinical application and promotion, high risk of clinical application of injections, etc., achieve stable pH value, facilitate clinical application and promotion, and reduce degradation substances.

Active Publication Date: 2011-04-13
SICHUAN SUNNYHOPE PHARM 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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  • Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition
  • Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition
  • Injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and preparation method of injection-purpose medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for preparing a pharmaceutical composition for injection that improves the stability of ligustrazine drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug based on ligustrazine, 9.0 g of sodium chloride, citron 1mg~2.0g sodium citrate, 1mg~2.0g sodium citrate; (2) citric acid and sodium citrate were prepared into 10%~20% solutions respectively for later use. (3) Add 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 citric acid or sodium citrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

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

[0027] Ligustrazine Hydrochloride 0.8g

[0028] Sodium chloride 9.0g...

Embodiment 2

[0033] Alternatively, the pharmaceutical composition for injection that improves the stability of the ligustrazine drug injection preparation is prepared according to the following steps:

[0034] (1) Weigh the crude drug with the calculated amount of ligustrazine 0.1g~100g, citric acid 1mg~2.0g, sodium citrate 1mg~2.0g; (2) citric acid and sodium citrate are prepared into 10% ~20% solution, set aside. (3) Add 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 citric acid or sodium citrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until clear, fill it, and sterilize it.

[0035] The specific components and contents thereof of the present embodiment are as follows:

[0036] Ligustrazine Hydrochloride 20g

[0037] Citric acid 1.0g

[0038] Sodium citrate 2.0g

[0039] ...

Embodiment 3

[0041] Comparative Test of Stability of Ligustrazine and Sodium Chloride Injection

[0042]Ligustrazine Sodium Chloride Injection prepared by using the present invention can detect the visible foreign matter in compliance with the drug quality standard, and the solution stability is very good. Under the condition of avoiding the use of other co-solvents that increase the risk of clinical application, Ligustrazine can be solved. Sodium chloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Ligustrazine Sodium Chloride Injection prepared by utilizing the present invention was investigated respectively in 25 DEG C for 24 months and 40 DEG C for 6 injections according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix XIXC drug 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. The results show that...

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Abstract

The invention discloses an injection-purpose medicine composition for improving stability of ligustrazine medicine injection formulation and a preparation method of the injection-purpose medicine composition. The injection-purpose medicine composition is prepared by the method comprising following steps: dissolving ligustrazine salt in water for injection, adjusting the pH value of the liquid medicine by adding citric acid and / or sodium citrate used as a pH regulator, wherein the dosage of the citric acid and / or sodium citrate ranges from (0.1mg to 200.0mg) / 100ml. In the invention, pH value of the injection liquid can be more stable, the content of ligustrazine degradation substance is greatly reduced compared with that of the prior art, the clarity of the ligustrazine injection liquid is improved under the condition of not using other cosolvents to increase the clinical application risk, particularly, the problems of small white spots, white blocks and solution turbidity are solved under the condition that the ligustrazine injection liquid is stored for a long time by adopting the prior art, and the medicine composition ensures that the inspection of visible foreign substances of the product is in accordance to the formulation of medicine quality standard, and is convenient for clinical medication and popularization.

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 a ligustrazine drug injection preparation and a preparation method thereof. Background technique [0002] Ligustrazine is an alkaloid extracted from the traditional Chinese medicine Ligusticum 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. Ligustrazine injection has made a great contribution to the treatment of modern difficult diseases by traditional Chinese medicine. [0003] Since ligustrazine has very poor solubility in aqueous solution, it is made into...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K31/4965A61P7/02A61P9/10
Inventor 毛长兴黄筱萍陈开军蒋巧梅廖晓君邱正霞
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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