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Injection pharmaceutical composition capable of improving stability of abrotani herba drug injection preparation

An injection preparation and injection technology, applied in the field of medicine, can solve the problems of high risk of clinical application of injections, easy rancidity, inconvenient clinical use and promotion, etc., to achieve easy clinical use and promotion, stable pH value of the liquid, and artemisia annua The effect of reducing degraded substances

Inactive Publication Date: 2017-02-15
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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  • Injection pharmaceutical composition capable of improving stability of abrotani herba drug injection preparation
  • Injection pharmaceutical composition capable of improving stability of abrotani herba drug injection preparation
  • Injection pharmaceutical composition capable of improving stability of abrotani herba drug injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for preparing a pharmaceutical composition for injection that improves the stability of an Artemisia annua drug injection preparation, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug calculated as Artemisia annua, 9.0 g of sodium chloride, and 1 mg of ascorbic acid ~2.0g, sodium ascorbate 1mg~2.0g; (2) ascorbic acid and sodium ascorbate were 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) Use ascorbic acid or sodium ascorbate 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.

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

[0027]

[0028] Ascorbic acid and sodiu...

Embodiment 2

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

[0031] (1) Weigh 0.1g-100g of the raw material medicine calculated as Artemisia annua, 1mg-2.0g of ascorbic acid, and 1mg-2.0g of sodium ascorbate; (2) prepare 10%-20% solutions of ascorbic acid and sodium ascorbate 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) Use ascorbic acid or sodium ascorbate 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.

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

[0033] Artemisia annua hydrochloride 20g

[0...

Embodiment 3

[0038] Comparative Test of Stability of Artemisia annua Sodium Chloride Injection

[0039] The detection of visible foreign matter of Artemisia annua Sodium Chloride Injection prepared by the present invention complies with the provisions of drug quality standards, 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, it solves the problem of Artemisia annua Sodium Chloride Injection. Sodium chloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the Artemisia annua 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 2...

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Abstract

The invention discloses an injection pharmaceutical composition capable of improving stability of an abrotani herba drug injection preparation. The injection pharmaceutical composition is mainly prepared by dissolving salt of abrotani herba into injection water, adding ascorbic acid and / or sodium ascorbate as a pH regulator to regulate the pH value of liquid drug, and the use amount of the ascorbic acid and / or sodium ascorbate is 0.1 mg-200.0 mg / 100 ml. The pH value of injection can be stable, compared with the prior art, the injection pharmaceutical composition has the feature that abrotani herba degradation substances are greatly reduced, under the condition that other cosolvents which increase clinical application risks are not used, the clarity of the abrotani herba injection is improved, particularly, the problems that the abrotani herba product in the prior art has small white spots and white blocks and the solution is turbid under the condition that the storage time is long are solved, examination of visible foreign matters of the product can conform to the stipulation of the drug standard, and clinical medication and popularization are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition for injection that improves the stability of an Artemisia annua drug injection preparation. Background technique [0002] Artemisia annua 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. The injection of Artemisia annua has made great contributions to the treatment of modern difficult diseases by traditional Chinese medicine. [0003] Since Artemisia annua has very poor solubility in aqueous solution, it is made into Artemisia hydrochloride...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/22A61K36/282A61P9/10A61P9/14A61P7/02A61P11/00
CPCA61K9/08A61K9/0019A61K36/282A61K47/22
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD