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Method for preparing pantocrine injection composition

An injection preparation and a technology of deer antler essence, which is applied in the field of medicine, can solve the problems of no better solution, unqualified inspection items of visible foreign matter, and easy precipitation of fine white spots, etc., achieve stable pH value, and facilitate clinical drug use and promotion Effect

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 velvet antler injection prepared with the above-mentioned pH value regulator is easy to precipitate fine white spots, white lumps, cloudy solution and other precipitates under long-term storage and low temperature conditions in winter, which makes the product unqualified for the inspection items of visible foreign matter
There is no better solution

Method used

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  • Method for preparing pantocrine injection composition
  • Method for preparing pantocrine injection composition
  • Method for preparing pantocrine injection 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 antler essence drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of raw materials calculated as antler essence, 9.0 g of chlorobutanol, 1 mg to 2.0 g of phthalic acid and 1 mg to 2.0 g of sodium phthalate; (2) phthalic acid and sodium phthalate are respectively prepared into 10% to 20% solutions 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 phthalic acid or sodium phthalate 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 to obtain .

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

[0022]

[0023] Phthalic acid ...

Embodiment 2

[0025] Alternatively, the above-mentioned pharmaceutical composition for injection that improves the stability of the velvet antler essence drug injection preparation is prepared according to the following steps:

[0026] (1) Weigh the raw material medicine with 0.1g~100g of deer antler essence, 1mg~2.0g of phthalic acid, and 1mg~2.0g of sodium phthalate; (2) prepare phthalic acid and sodium phthalate 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 phthalic acid or sodium phthalate 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 to obtain .

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

[0028] Deer Antler Hydrochloride 2...

Embodiment 3

[0033] Comparative test on the stability of deer antler essence chlorobutanol injection

[0034] The detection of visible foreign matter in the velvet antler essence chlorobutanol 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 solution is solved. Deer antler essence chlorobutanol injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the antler essence chlorobutanol injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC drug preparation stability test guideline, investigated respectively placed at 25 ℃ for 24 months, 40 ℃ placed Drug stability after 6 months, 10 days at 60°C, and 20 days at 0-5°C low temperature. The result is...

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Abstract

The invention discloses a method for preparing a pantocrine injection composition. The injection composition is mainly prepared by dissolving a salt of pantocrine into injection water, and adding phthalic acid and / or sodium phthalate as a pH adjusting agent to adjust the pH value of the medicinal liquid, wherein the amount of phthalic acid and / or sodium phthalate is 0.1-200.0mg / 100ml. By adoptingthe method, the pH value of the injection composition is relatively stable, the amount of pantocrine degradation substances is greatly reduced when compared with that of the prior art, the clarity ofpantocrine injection is improved under the condition that no other cosolvent which can increase clinical application risks is used, particularly the problems that small white cakes, white blocks and solution turbidity can be caused to a conventional pantocrine injection product of the prior art in a relatively long storage term are solved, visible foreign matter inspection of the product meets provisions of medicine quality standards, and convenience can be brought to clinical medication and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of antler essence injection pharmaceutical composition. Background technique [0002] The main function of deer antler essence is to invigorate the kidney and yang, generate essence and tonify marrow, and strengthen muscles and bones. For deficiency of kidney yang, deficiency of essence and blood. [0003] Because velvet antler has poor solubility in aqueous solution, it is made into velvet antler hydrochloride or velvet phosphate to increase its water solubility. The currently commercially available antler essence injections mainly include small-volume injections of antler essence hydrochloride and antler essence phosphate, and adding glucose or chlorobutanol as a bacteriostatic agent to the antler essence hydrochloride and antler essence phosphate solutions Made of large-volume injection. But when preparing the above injection, the pH value...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K35/32A61K47/12A61P1/14
CPCA61K9/08A61K9/0019A61K35/32A61K47/12
Inventor 陈通
Owner CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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