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Preparation method of houttuyfonate injection preparation pharmaceutical composition

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

Inactive Publication Date: 2018-03-06
CHENGDU XIANXIANXIAN 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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  • Preparation method of houttuyfonate injection preparation pharmaceutical composition
  • Preparation method of houttuyfonate injection preparation pharmaceutical composition
  • Preparation method of houttuyfonate injection preparation pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 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 houttuybein, lidocaine hydrochloride 9.0g, tartaric acid 1mg-2.0g, sodium tartrate 1mg-2.0g; (2) Tartaric acid and sodium tartrate were prepared into 10%-20% solutions respectively 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) Adjust the pH value of the filtrate to 3.0-7.0 with tartaric acid or sodium tartrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0021] The specific components and contents thereof of the present embodiment are as follows:

[0022]

[0023] Tartaric acid and sodium tartrate wer...

Embodiment 2

[0025] Alternatively, the above-mentioned injection pharmaceutical composition for improving the stability of Houttuyfonate injection preparations is prepared according to the following steps:

[0026] (1) Weigh 0.1g-100g of the raw material medicine, 1mg-2.0g of tartaric acid, 1mg-2.0g of sodium tartrate; (2) prepare 10%-20% solutions of tartaric acid and sodium tartrate respectively, spare. (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) Adjust the pH value of the filtrate to 3.0-7.0 with tartaric acid or sodium tartrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

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

[0028] Houttuyfonate Hydrochloride 20g

[0029] Tartaric acid 1.0g

[0030] Sodium tartrate 2.0g

[...

Embodiment 3

[0033] Comparative test on the stability of Houttuyfonate Lidocaine Hydrochloride Injection

[0034] The detection of visible foreign matter of Houttuyfonate Lidocaine Hydrochloride 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, the solution can be solved. Houttuyfotin lidocaine hydrochloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the houttuybene hydrochloride lidocaine hydrochloride injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ Ⅹ C drug preparation stability test guideline, investigated respectively placed at 25 ℃ for 24 months, 40 ℃ The stability of the drug was stored for 6 months, 10 days at 60°C, and 20 day...

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Abstract

The invention discloses a preparation method of a houttuyfonate injection preparation pharmaceutical composition. The pharmaceutical composition for injection is a pharmaceutical composition for injection, which is prepared by dissolving salt of houttuyfonate into water for injection, adding tartaric acid and / or sodium tartrate as a pH regulator and regulating the pH value of medicine liquid, wherein the dosage of the tartaric acid and / or the sodium tartrate is 0.1mg / 100ml to 200.0mg / 100ml. By adopting the preparation method of the houttuyfonate injection preparation pharmaceutical composition, the pH value of injection liquid is more stable; the content of houttuyfonate degraded substances is greatly reduced as compared with that in the prior art,; under the condition that other co-solvents which increase the clinical application risk are not used, the clarity of houttuyfonate injection is improved; and the problems that a houttuyfonate injection product in the prior art has small white spots and white blocks and a solution is turbid under the condition that the product is stored for relatively long time are especially solved, the checking of visible foreign matters of the productcan meet the regulations of drug quality standards and the houttuyfonate injection preparation pharmaceutical composition 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 preparation method of a pharmaceutical composition of houttuyfonate injection preparation. 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 aqueou...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/185A61K31/167A61K47/12A61P29/00A61P31/04
CPCA61K9/08A61K9/0019A61K31/167A61K31/185A61K47/12A61K2300/00
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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