Preparation method for stable composition of breviscapine drug injection preparation

A technology of breviscapine and injection preparations, which is applied in the field of medicine, can solve problems such as easy rancidity, high risk of clinical application of injections, and inconvenient clinical use and promotion, achieve stable pH value, facilitate clinical use and promotion, breviscapine Effect of reducing degraded substances

Inactive Publication Date: 2016-12-14
成都佳迪璐莎生物科技有限公司
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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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] A preparation method for a stable composition of breviscapine pharmaceutical injection preparations, comprising the following steps: (1) Weighing 25 g of raw materials calculated from breviscapine extract, 7.0 g of sodium chloride, 2 g of malic acid, 2 g of malic acid Sodium 4mg; (2) Malic acid and sodium malate were prepared into 10%-20% solutions respectively for later use; (3) Added to 500ml of water for injection below 40°C, stirred until completely dissolved, then added 0.02% (g / ml) of activated carbon, stirred for 15 minutes, and decarbonized by filtration; (4) The filtrate was adjusted to a pH of 3.0-7.0 with malic acid or sodium malate solution, and water for injection below 40°C was added to 1000ml; (5) The liquid was filtered to Clarify, fill, sterilize, and get ready.

[0020] The specific components and contents thereof of the present embodiment are as follows:

[0021] Breviscapine extract 25g

[0022] Sodium chloride 7.0g

[0023] Malic acid 2.0g

[0...

Embodiment 2

[0027] Another embodiment of this example, as shown below, the above-mentioned pharmaceutical composition for injection that improves the stability of the breviscapine drug injection preparation is prepared according to the following steps:

[0028] (1) Weigh 70g of the raw material medicine calculated as breviscapine, 3g of malic acid, and 6g of sodium malate; (2) Prepare 10%-20% solutions of malic acid and sodium malate respectively for use; (3) Add Add 0.15% (g / ml) activated carbon to 500ml of water for injection below 40°C until it is completely dissolved, then add 0.15% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize; 4.0 to 6.0, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until clarified, fill it, and sterilize it.

[0029] The specific components and contents thereof of the present embodiment are as follows:

[0030] Breviscapine extract 70g

[0031] Malic acid 3g

[0032] Sodium malate 5g

[0033] Malic acid and...

Embodiment 3

[0035] Comparative test on the stability of breviscapine injection

[0036] The detection of visible foreign matter in the breviscapine injection prepared by the present invention meets the requirements of the drug quality standard, and the solution has good stability, and solves the problem of breviscapine injection while avoiding the use of other co-solvents that increase the risk of clinical application. The solution is prone to problems such as small white spots, white blocks, and cloudy solution during storage. Utilize the prepared breviscapine injection of the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC pharmaceutical preparations stability test guideline requirements, investigated respectively at 25 ℃ for 24 months, 40 ℃ for 6 months, The stability of the drug was stored at 60°C for 10 days and at low temperature of 0-5°C for 20 days. As a result, the product quality was stable under the above test...

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PUM

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Abstract

The invention discloses a preparation method for a stable composition of a breviscapine drug injection preparation. The preparation method comprises the following steps that 1, breviscapine, malic acid and / or sodium malate are weighed; 2, a malic acid solution and a sodium malate solution are prepared separately; 3, breviscapine is added into 500 ml of water for injection at the temperature of 30 DEG C to 40 DEG C, after stirring is conducted till the breviscapine is completely dissolved, activated carbon is added, stirring is conducted, and filtering is conducted for decarburization; 4, the pH value of the obtained filtrate is regulated to be 4.0 to 6.0 with the prepared malic acid solution and / or sodium malate solution, and the water for injection is added till the volume is 1,000 ml; 5, filtering is conducted till the filtrate is clarified, filling and sterilizing are conducted, and then the stable composition is obtained. According to the preparation method, the pH value of the injection can be stabler, breviscapine degrading substances are greatly decreased compared with the prior art, the clarification degree of the breviscapine injection is improved on the condition that usage of other cosolvents increasing clinical application risks is avoided, it can be guaranteed that visible foreign matter inspection accords with provisions of drug quality standards, and clinical medication and popularization are convenient.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a stable composition of breviscapine drug injection preparation. Background technique [0002] Breviscapine has the effect of dilating cerebral blood vessels, reducing cerebrovascular resistance, increasing cerebral blood flow, improving microcirculation, and resisting platelet aggregation. Therefore, it can be used to treat ischemic cerebrovascular diseases, such as cerebral thrombosis, cerebral embolism, cerebral hemorrhage and other sequelae paralyzed patients, and has a good curative effect. [0003] Since scutellarin has very poor solubility in aqueous solution, it is made into scutellarin hydrochloride or scutellarin phosphate to increase its water solubility. The currently commercially available breviscapine injections mainly include small volume injections of breviscapine hydrochloride and breviscapine phosphate, and those prepared by...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7048A61K47/12A61P9/10
CPCA61K31/7048A61K9/0019A61K9/08A61K47/12
Inventor 李云娟
Owner 成都佳迪璐莎生物科技有限公司
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