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Preparing method of pharmaceutical composition for improving chaenomeles-cathayensis pharmaceutical injection preparation stability

An injection preparation, the technology of wild papaya, applied in the field of medicine, can solve the problems of easy rancidity, inconvenience of clinical medication and promotion, and high risk of clinical application of injections, and achieve the effect of stable pH value, convenient clinical medication, and reduction of wild papaya degraded substances

Inactive Publication Date: 2016-11-23
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] The preparation method of the pharmaceutical composition for improving the stability of wild papaya drug injection preparations comprises the following steps: (1) Weighing 5 g of raw materials calculated as wild papaya extract, 9.0 g of xylitol, 1 mg of tartaric acid, and 2.0 mg of sodium tartrate ; (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, and then added 0.02% (g / ml) of activated carbon , stirred for 15 minutes, filtered and decarburized; (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, filled, and extinguished. Bacteria, that is.

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

[0021] Wild papaya extract 5g

[0022] Xylitol 9.0g ...

Embodiment 2

[0027] 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:

[0028] (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 If 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.

[0029] The specific composition and content of each component of the present embodiment are as follows:

[0030] Wild papaya extr...

Embodiment 3

[0035] Comparative Test of Stability of Wild Papaya Injection

[0036] 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 a preparing method of a pharmaceutical composition for improving the chaenomeles-cathayensis pharmaceutical injection preparation stability. The preparing method includes the following steps that 1, extracting liquid of chaenomeles cathayensis and tartaric acid and / or sodium tartrate are weighed; 2, a tartaric acid solution and a sodium tartrate solution are prepared respectively; 3, the extracting liquid of the chaenomeles cathayensis is added into 500 ml of injection water at the temperature of 30 DEG C to 40 DEG C, the mixture is stirred to be completely dissolved, then active carbon is added, and the mixture is stirred, filtered and decarburized; 4, the pH value of the obtained filtering liquid is adjusted to 0 to 7.0 with the prepared tartaric acid and / or sodium tartrate solution, and injection water is added to 1,000 ml; 5, the mixture is filtered to be clarified, filled and sterilized, and the pharmaceutical composition is prepared. By means of the preparing method, the pH value of the injection liquid is more stable, and compared with the prior art, the degradation substances of the chaenomeles cathayensisis are greatly reduced, and under the condition that other solubilizing assistants capable of increasing clinical application risks are avoided, the limpid degree of the chaenomeles-cathayensis injection liquid is improved, it can be guaranteed that the visible foreign matter inspection of the product meets the stipulation of the medicine quality standard, 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 pharmaceutical composition for improving the stability of wild papaya drug injection preparations. Background technique [0002] Wild papaya injection, expelling wind and relieving pain, relaxing tendons and activating collaterals. For wind pathogen blocking collateral type trigeminal neuralgia, sciatica. [0003] Because wild papaya has very poor solubility in aqueous solution, it is made into wild papaya hydrochloride or wild papaya phosphate to increase its water solubility. Currently, wild papaya injections on the market mainly include small-volume injections of wild papaya hydrochloride and wild papaya phosphate, and large-volume injections made by adding glucose or sodium chloride to the wild papaya extract solution as an osmotic pressure regulator. . But when preparing the above injection, the pH value of the medicinal liquid must ...

Claims

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Application Information

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IPC IPC(8): A61K36/185A61K9/08A61K47/12A61P25/02
CPCA61K36/185A61K9/0019A61K9/08A61K47/12
Inventor 李云娟
Owner 成都佳迪璐莎生物科技有限公司
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