Injection pharmaceutical composition for improving stability of rhizoma dioscoreae nipponicae drug injection preparation

An injection preparation and pansangon technology, applied in the field of medicine, can solve the problems of high risk of clinical application of injection, inconvenient clinical medication and promotion, easy rancidity, etc., and achieve the effects of convenient clinical medication and promotion, stable pH value, and reduction of degradable substances.

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

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

[0024] A method for preparing a pharmaceutical composition for injection that improves the stability of pangolina drug injection preparations, comprising the following steps: (1) weighing 5 g of the raw material medicine, calculated from pangolina pangolin extract, 5.0 g of sodium chloride, 1.2 g of formic acid, and sodium formate 2.0g; (2) Formic acid and sodium formate 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) Activated carbon, stirred for 15 minutes, filtered for decarburization; (4) The filtrate was adjusted to a pH value of 5.0-7.0 with formic acid or sodium formate 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.

[0025] The specific components and contents thereof of the present embodiment are as follows:

[0026] Pangosaurus Ext...

Embodiment 2

[0032] Another embodiment of this example, as shown below, the above-mentioned pharmaceutical composition for injection that improves the stability of the pangolina drug injection preparation is prepared according to the following steps:

[0033] (1) Weigh 55g of the raw material medicine, 3g of formic acid, and 3g of sodium formate; (2) Prepare 10% to 20% solutions of formic acid and sodium formate, 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) Use formic acid or sodium formate solution to adjust the pH value of the filtrate If it is 5.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0034] The specific components and contents thereof of the present embodiment are as follows:

[0035] Pangosaurus Extract 35g

[0036] Formic acid 3g

[0037] Sodiu...

Embodiment 3

[0040] Comparative Test of Stability of Chuanshanlong Injection

[0041] The detection of visible foreign matter of the Chuanshanlong 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, the storage process of the Chuanshanlong injection is solved. Problems such as small white spots, white lumps, and cloudy solution are prone to appear in the solution. According to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix ⅪⅩC drug preparation stability test guideline, the Chuanshanlong injection prepared by utilizing the present invention was placed at 25°C for 24 months, at 40°C for 6 months, and at 60°C. The stability of the drug was placed for 10 days and placed at a low temperature of 0-5°C for 20 days. As a result, the quality of the product was stable u...

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PUM

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Abstract

The invention discloses an injection pharmaceutical composition for improving stability of a rhizoma dioscoreae nipponicae drug injection preparation. The injection pharmaceutical composition is mainly prepared by dissolving an extracting solution of rhizoma dioscoreae nipponicae in water, and regulating pH value of medicine liquid with the addition of formic acid and/or sodium formate which serves as a pH regulator, wherein the dosage of the formic acid and/or the sodium formate is 1-3g/100ml. According to the injection pharmaceutical composition disclosed by the invention, the stability of the pH value of the injection (the injection pharmaceutical composition) is enhanced, the content of rhizoma dioscoreae nipponicae degradable substances is greatly reduced in comparison with the prior art, and the clarity of the rhizoma dioscoreae nipponicae injection is improved under the circumstance of avoiding the use of other cosolvents which can increase the risk of clinical application; especially, the problems of the prior art that small white spots, white plaques and solution turbidity easily occur in a finished rhizoma dioscoreae nipponicae injection product can be solved; the obvious foreign matter inspection of the product (the injection pharmaceutical composition) can conform to the specifications of drug quality standard; and the injection pharmaceutical composition is convenient for clinical medication and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition for injection that improves the stability of pangolinus injection preparations. Background technique [0002] Chuanshanlong, also known as Chuanlong yam, wild yam, Chuandilong, ground keel, chicken bone, and dragon's stalk. Perennial twining herbaceous vines, rhizomes run horizontally, cork falls off in flakes, and the section is yellow. As a medicine, its rhizome has the effects of relaxing tendons and activating collaterals, expelling wind and relieving pain. [0003] Since pangolin has very poor solubility in aqueous solution, it is made into pangolin hydrochloride or pangolin phosphate to increase its water solubility. The currently commercially available pangolin injections mainly include small-volume injections of pangolin hydrochloride and pangolin phosphate, and large volume injections made by adding glucose or sodium chloride ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K36/8945A61K47/12A61K47/26A61K47/02A61K47/10A61P29/00A61K125/00
CPCA61K36/8945A61K9/0019A61K9/08A61K47/02A61K47/10A61K47/12A61K47/26
Inventor 李云娟
Owner 成都佳迪璐莎生物科技有限公司
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