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Identification method of polysorbate 80 in injection and Shenmai injection

A technology of Shenmai injection and polysorbate, applied in the identification field of polysorbate 80, can solve the problems such as no reports on the identification of polysorbate 80 auxiliary materials, and achieve the effects of wide application range, high purity and simple method

Active Publication Date: 2019-01-11
YAAN THREE NINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there is no report on the identification of polysorbate 80 excipients in traditional Chinese medicine injections (whether it is polysorbate 80 for injection)

Method used

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  • Identification method of polysorbate 80 in injection and Shenmai injection
  • Identification method of polysorbate 80 in injection and Shenmai injection
  • Identification method of polysorbate 80 in injection and Shenmai injection

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0070] Study on the Effect of Heating Time on the Extraction of Polysorbate 80

[0071] Take 9 tubes of Shenmai injection (10mL size, in ampoules), divide them into 3 groups, 3 tubes in each group, turn them upside down, and heat them at 115°C for 5min, 10min, and 20min respectively. Rinse and cool with water at about 30°C, wait for 0.5 hours, put the ampoule upright, and observe the amount of polysorbate 80 attached to the head of the ampoule. Results The amount of polysorbate 80 attached to the sample ampoules at the above three heating times was basically the same.

experiment example 2

[0073] Study on the Effect of Heating Temperature on the Extraction of Polysorbate 80

[0074] Take 9 tubes of Shenmai injection (10mL size, bottled in ampoules), divide them into 3 groups, 3 tubes in each group, turn them upside down, heat them at 100°C, 115°C, and 121°C for 10 minutes respectively, and when the liquid is cooled to 80°C, turn them upside down Take it out, rinse and cool it with water at about 30°C, wait for 0.5 hours, put the ampoule upright, and observe the amount of polysorbate 80 attached to the head of the ampoule bottle. Results For the sample ampoule heads at the above three heating temperatures, the adhesion amount of polysorbate 80 was less under the heating condition of 100°C, and the adhesion amount of polysorbate 80 was more and basically the same under the heating conditions of 115°C and 121°C. It shows that the heating temperature has a certain influence on the extraction amount of polysorbate 80 Tween, and 115°C is selected as the optimum heatin...

experiment example 3

[0076] Study on the Effect of Natural Cooling Time on the Extraction of Polysorbate 80

[0077] Take 9 tubes of Shenmai Injection (10mL, bottled in ampoules), divide them into 3 groups, 3 tubes in each group, turn them upside down, and heat them at 115°C for 10 minutes. , Take it upside down, rinse and cool with water at about 30°C, wait for 0.5 hours, put the ampoule upright, and observe the amount of polysorbate 80 attached to the head of the ampoule. Results For the sample ampoule head at the above cooling temperature, the amount of polysorbate 80 attached to the sample cooled to 50°C was almost invisible, and the amount of polysorbate 80 attached to the sample cooled to 75°C and 95°C was much and the amount of adhesion was basically the same. It shows that the cooling temperature has a certain influence on the extraction amount of polysorbate 80 Tween, and the optimum cooling end point temperature is above 75°C.

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Abstract

The invention provides an identification method of polysorbate 80 in an injection and a Shenmai injection. The identification method of the polysorbate 80 in the injection and Shenmai injection comprises the following steps: step A, an injection to be tested is heated at 90 to 150 degrees centigrade, and then the container for the injection to be tested is inverted; and when cooled to above 75 degrees centigrade, the injection to be tested is quenched to below 50 degrees centigrade and stood until the polysorbate 80 is completely precipitated; and step B, the polysorbate 80 precipitated in thestep A is saponified and pre-column derivatized, and then the content of oleic acid in the polysorbate 80 is detected by means of chromatography. The identification method of the polysorbate 80 in the injection and Shenmai injection can effectively extract the polysorbate 80 in the injection, and establishes a reliable basis for accurately identifying the quality of the polysorbate 80; and the identification method of the polysorbate 80 in the injection and Shenmai injection has a strong specificity, and the result is reliable.

Description

technical field [0001] The invention relates to the technical field of quality standards, in particular to a method for identifying polysorbate 80 in injections and Shenmai injections. Background technique [0002] In 2015, the Chinese Pharmacopoeia added the quality standard of polysorbate 80 (for injection), which is quite different from the quality standard substance of polysorbate 80. [0003] The standard fatty acid composition of polysorbate 80 (for injection) stipulates that the composition of oleic acid shall not be less than 98%, and the content of myristic acid, palmitic acid, palmitoleic acid, stearic acid, linoleic acid and linolenic acid shall not exceed 0.5%. . [0004] Polysorbate 80 standard substance standard fatty acid composition regulations: oleic acid composition shall not be less than 58%, myristic acid, palmitic acid, palmitoleic acid, stearic acid, linoleic acid, linolenic acid shall not be greater than 5.0%, 16.0%, 8.0%, 6.0%, 18.0%, 4.0%. [0005...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/02
CPCG01N30/02G01N30/06G01N2030/067
Inventor 董礼吴建国梅国荣史琳莉李科田大力
Owner YAAN THREE NINE PHARMA