Quality evaluation and quality research of domestic hydroxyethyl starch 130/0.4 injection

doi:10.19803/j.1672-8629.20220224

Abstract

Abstract: Objective To evaluate the quality status and existing problems of domestic hydroxyethyl starch 130/0.4 injection, and provide a basis for the establishment and revision of national drug standards. Methods All of the samples by national sampling evaluation were tested, and the results were statistically analyzed. Exploratory research works were carried out on items such as molar degree of substitution, C2/C6 ratio, molecular weight and molecular weight distribution, and residual solvents. Results 146 batches of samples from 15 manufacturers were tested, and 6 batches were unqualified, the overall unqualified rate was 4.1%, and the unqualified items were the loading and visible particles. The exploratory study found that the relative molecular weight and its distribution, the molar substitution degree and the accuracy of the sodium chloride determination method in some registration standards should be revised. Conclusion At present, the quality of domestic hydroxyethyl starch 130/0.4 injection is just passable. Quality standards are numerous and varied. It is recommended to unify and improve the quality standards as soon as possible.

Key words: hydroxyethyl starch, quality analysis, quality standards, relative molecular weight, relative molecular weight distribution, assay, molar substitution, C2/C6

CLC Number:

R927.11

WANG Yue, SONG Yujuan, LIU Qian, ZHAO Xiangmei, DENG Lijuan, FAN Huihong. Quality evaluation and quality research of domestic hydroxyethyl starch 130/0.4 injection[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1067-1072.

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