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Corydalis decumbentis pharmaceutical composition for injection

A composition and a technology for injection, applied in the field of medicine, can solve the problems such as no good solution, unqualified inspection items for visible foreign bodies, easy precipitation of small white spots, etc., and achieves a stable pH value of the medicinal solution and is convenient for clinical medication. and promotion effect

Inactive Publication Date: 2018-03-06
CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But when preparing the above injection, the pH value of the medicinal liquid must be adjusted to a certain range suitable for human injection administration. The pH value regulators used in current literature reports are sodium hydroxide solution or use hydrochloric acid solution and phosphoric acid solution, but The summer non-injection prepared by using the above-mentioned pH value regulator is easy to precipitate fine white spots, white lumps, solution turbidity and other precipitates under long-term storage and winter low temperature conditions, resulting in the unqualified inspection items of visible foreign matter of the product
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Method used

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  • Corydalis decumbentis pharmaceutical composition for injection
  • Corydalis decumbentis pharmaceutical composition for injection
  • Corydalis decumbentis pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A method for preparing a pharmaceutical composition for injection that improves the stability of summer-free drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of summer-free drug, 9.0 g of phenylmercuric nitrate, 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.

[0027] The specific components and contents thereof of the present embodiment are as follows:

[0028]

[0029] Ascorbic acid and sodium ascorbate are respectively prepa...

Embodiment 2

[0031] Alternatively, the above-mentioned pharmaceutical composition for injection that improves the stability of Xiaxia drug-free injection preparations is prepared according to the following steps:

[0032] (1) Weigh 0.1g-100g of raw material medicine, 1mg-2.0g of ascorbic acid, 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.

[0033] The specific components and contents thereof of the present embodiment are as follows:

[0034] Hydrochloric acid summer free 20g

[0035] Ascorbic acid 1.0g

[0036] Sodium Asco...

Embodiment 3

[0039] Comparative experiment on stability of phenylmercury nitrate-free injection in summer

[0040] The detection of visible foreign matter in the summer non-phenylmercury nitrate injection prepared by the present invention complies with the provisions of 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, it solves the problem of summer non-phenylmercury nitrate injection. Phenylmercuric nitrate injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. According to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix ⅪⅩC drug preparation stability test guideline, the Xiaxia phenylmercury nitrate-free injection prepared by utilizing the present invention was placed at 25°C for 24 months and 6 at 40°C respectively. The stability of the drug can be obtained by placing it at 60°C...

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Abstract

The invention discloses a corydalis decumbentis pharmaceutical composition for injection. The pharmaceutical composition for injection is mainly prepared by the following steps: dissolving corydalis decumbentis salt into water for injection, and adding ascorbic acid and / or sodium ascorbate as a pH regulator to regulate the pH value of soup, wherein the usage amount of ascorbic acid and / or sodium ascorbate is 0.1mg-200.0mg / 100ml. Through the pharmaceutical composition for injection, the pH value of injection is more stable, corydalis decumbentis degradation substances can be greatly reduced compared with the prior art, the clarity of the corydalis decumbentis injection can be improved under the condition of no use of other cosolvent increasing clinical application risk, especially, the problems that corydalis decumbentis injection adopting existing technical products has small white spots and white blocks and is turbid when stored for a long time can be solved, the visible foreign matter detection of the product can meet the quality standard of drugs, and the 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 summer-free pharmaceutical composition for injection. Background technique [0002] In summer, it is not used for stroke hemiplegia, headache, injury from falling, rheumatic arthralgia, waist and leg pain. [0003] Due to the extremely poor solubility of summer water in aqueous solution, it is made into summer free hydrochloride or summer free phosphate to increase its water solubility. The currently commercially available summer-free injections mainly include small-volume injections of summer-free hydrochloride and summer-free phosphate, and adding glucose or phenylmercuric nitrate as a bacteriostatic agent to the summer-free hydrochloride and summer-free phosphate solution Made of large-volume injection. But when preparing the above injection, the pH value of the medicinal liquid must be adjusted to a certain range suitable for human injection administration. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/66A61K9/08A61K47/22A61P9/10A61P25/00A61P29/00
CPCA61K36/66A61K9/0019A61K9/08A61K47/22
Inventor 陈通
Owner CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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