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Injection drug composition for improving stability of stauntonia chinensis drug injection

A technology for injection preparation and wild papaya, applied in the field of medicine, can solve the problems of inconvenience of clinical medication and promotion, high risk of clinical application of injection, easy rancidity, etc., and achieves convenient clinical medication and promotion, reduction of degradable substances of wild papaya, pH value stable effect

Inactive Publication Date: 2016-11-16
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

Benefits of technology

This patented method helps stabilizing the p H level of drugs by adding citric acid or salts thereof into their solutions with certain chemical compounds like tartarside glycerin (TG) or hydroxypropyltriethoxysilane (HPTS). These modifications help reduce crystal formation on surfaces such as glass bottles made from these materials due to interactions between them. By adjusting this concentration ratio, it becomes possible to achieve specific desired properties without making any changes at all.

Problems solved by technology

This patented technical problem addressed in this patents is that existing methods have difficulty preventing aggregations from forming on nerve tissue due to their lack of good solvability with water molecules. These techniques involve injecting tiny amounts (less than 1 mL) of wild paper pulp extracts called guaiacol salts through syringe tubes filled with buffer liquids like glycerin/NaCl.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for preparing a pharmaceutical composition for injection that improves the stability of wild papaya drug injection preparations, comprising the following steps: (1) weighing 5 g of the raw material drug calculated as the wild papaya extract, 9.0 g of xylitol, 1 mg of tartaric acid, Sodium tartrate 2.0 mg; (2) Tartaric acid and sodium tartrate were prepared into 10% to 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 decarburized by filtration; (4) The filtrate was adjusted to pH 3.0-7.0 with tartaric acid or sodium tartrate solution, and water for injection below 40°C was added to 1000ml; (5) The liquid was filtered until clear, Filling, sterilization, that is.

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

[0027] Wild papaya extract 5g

[0028] Xylitol 9...

Embodiment 2

[0033] Another embodiment of this example, as shown below, the above-mentioned pharmaceutical composition for injection that improves the stability of the wild papaya drug injection preparation is prepared according to the following steps:

[0034] (1) Weigh 20g of the raw material medicine based on wild papaya, 1mg-2.0g of tartaric acid, and 1mg-2.0g of sodium tartrate; (2) prepare 10%-20% solutions of tartaric acid and sodium tartrate respectively for later use. (3) Add 500ml of water for injection below 40°C, stir until completely dissolved, add 0.2% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize; (4) Adjust the pH of the filtrate with tartaric acid or sodium tartrate solution When the value is 6.0-8.0, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0035] The specific components and contents thereof of the present embodiment are as follows:

[0036] Wild papaya extract 20g ...

Embodiment 3

[0041] Comparative Test of Stability of Wild Papaya Injection

[0042] The detection of visible foreign matter of the wild papaya injection prepared by the present invention meets the requirements 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, the wild papaya injection is solved. Problems such as small white spots, white lumps, and cloudy solution are prone to appear during storage. Utilize the wild papaya injection that the present invention makes according to the relevant requirements of Chinese Pharmacopoeia 2005 edition two appendix Ⅺ Ⅹ C drug preparation stability test guiding principle, have investigated respectively to place 24 months at 25 ℃, 6 months at 40 ℃, 60 ℃ for 10 days, and 0-5 ℃ for 20 days for drug stability. The results show that the product quality is stable under the above test conditions, and all the testing indicators are i...

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Abstract

The invention discloses an injection drug composition for improving stability of stauntonia chinensis drug injection. The injection drug composition is mainly prepared by means of dissolving extracting solution of stauntonia chinensis in water for injection and adding 1mg-10.0mg/100ml of tartaric acid and/or sodium tartrate as a pH regulator to regulate the pH value of the solution. By the injection drug composition, the pH value of the injection can be more stable, recalcitrant substances of stauntonia chinensis are decreased greatly as compared with those in the prior art, clarity of stauntonia chinensis injection is improved under the condition that other cosolvents increasing risk of clinical application are avoided in use, particularly the problem that the stauntonia chinensis injection adopting products in the prior art is prone to having small particles, white blocks and turbid solution under the condition of long storage time is solved, visible foreign matter inspection of products can meet requirements of drug standard, and clinical medication and popularization are facilitated.

Description

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Claims

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Application Information

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Owner 成都佳迪璐莎生物科技有限公司
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