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Injection medicinal composition of houttuyfonate

A technology for houttuyniacin and injection, applied in the field of medicine, can solve the problems such as no better solution, unqualified inspection items for visible foreign bodies, easy precipitation of small white spots, etc. Effects of pH stabilization and reduction of Houttuyniacin-degrading substances

Inactive Publication Date: 2018-02-27
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 Houttuyniatin injection prepared with 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 low temperature conditions in winter, resulting in the failure of the visible foreign matter inspection item of the product
There is no better solution

Method used

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  • Injection medicinal composition of houttuyfonate
  • Injection medicinal composition of houttuyfonate
  • Injection medicinal composition of houttuyfonate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A method for preparing a pharmaceutical composition for injection that improves the stability of houttuybein drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material medicine calculated as houttuyfonate, and 9.0 g of sodium metabisulfite , citric acid 1mg~2.0g, sodium citrate 1mg~2.0g; (2) citric acid and sodium citrate 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 citric acid or sodium citrate 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] Citric acid and sodium citrate were pr...

Embodiment 2

[0031] Alternatively, the above-mentioned injection pharmaceutical composition for improving the stability of Houttuyfonate injection preparations is prepared according to the following steps:

[0032] (1) Weigh 0.1g-100g of the raw material medicine, 1mg-2.0g of citric acid, 1mg-2.0g of sodium citrate; (2) prepare citric acid and sodium citrate respectively 10% to 20% solution 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) Use citric acid or sodium citrate 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] Houttuyfonate Hydrochloride 20g

[0035] Citric acid 1.0g

[0036] Sodium citrate 2.0g

[0037] C...

Embodiment 3

[0039] Comparative test on the stability of Houttuydin Sodium Metabisulfite Injection

[0040] The detection of visible foreign matter in Houttuyfonate Sodium Metabisulfite 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, it solves the problem of fish During the storage process, the Houttuybein Sodium Metabisulfite Injection is prone to problems such as small white spots, white lumps, and cloudy solution. Utilize the Houttuyfonate Sodium Metabisulfite Injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 Edition Two Appendix XIXC Drug Preparation Stability Test Guiding Principles, investigated respectively placed at 25 ℃ for 24 months, 40 ℃ for 6 months months, 10 days at 60°C, and 20 days at 0-5°C for 20 days. As a...

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Abstract

The invention discloses an injection medicinal composition of houttuyfonate. The injection medicinal composition is mainly prepared by the steps of dissolving salt of houttuyfonate in injection water,and adding citric acid and / or sodium citrate to serve as a pH regulator to adjust the pH value of medicinal liquid, wherein the dose of the citric acid and / or sodium citrate is 0.1-200.0mg / 100ml. According to the injection medicinal composition, the pH value of injection can be more stable, the houttuyfonate recalcitrant substance is greatly reduced in comparison with that in the prior art, the clarity of a houttuyfonate injection can be improved under the condition that other co-solvent increasing clinical application risk is prevented from being used, the problems of small white dots, whiteblocks and solution turbidity occurring in the houttuyfonate injection can be solved when the product is stored for a relatively long time by adopting the prior art, the condition that the visible foreign inspection of a product can accord with the specification of drug standard can be guaranteed, and clinical administration and popularization can be facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for injection of houttuyfonate. Background technique [0002] Houttuyniatin is sodium decanoyl acetaldehyde bisulfite. White scaly or needle-like crystals or crystal powder. The melting point is 164-167°C (decomposition). Soluble in water, easily soluble in ethanol. It has a certain inhibitory effect on influenza bacillus, drug-resistant staphylococcus aureus, tuberculosis bacillus, etc., and can enhance the phagocytosis ability of white blood cells in the body and increase serum interleukin, so it can mobilize the body's immunity. For anti-inflammatory and antibacterial, for chronic bronchitis, chronic cervicitis, adnexitis, pneumonia in children. Preparations include injections, tablets, and tablets for external use (cervicitis tablets). [0003] Since Houttuyfonate has very poor solubility in aqueous solution, it is made into Hout...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/185A61K47/14A61P31/04
CPCA61K9/08A61K9/0019A61K31/185A61K47/14
Inventor 陈通
Owner CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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