Study on Sterility Test of Non-aqueous Clonazepam Injection

Lu WANG; Dong XIANG; Yan ZHANG; Qin LIU; Shan HUANG; Fan XU

doi:10.12259/j.issn.2095-610X.S20231112

Volume 44 Issue 11

Nov. 2023

Turn off MathJax

Article Contents

Article Navigation > Journal of Kunming Medical University > 2023 > 44(11): 82-86

Lu WANG, Dong XIANG, Yan ZHANG, Qin LIU, Shan HUANG, Fan XU. Study on Sterility Test of Non-aqueous Clonazepam Injection[J]. Journal of Kunming Medical University, 2023, 44(11): 82-86. doi: 10.12259/j.issn.2095-610X.S20231112

Citation:

Lu WANG, Dong XIANG, Yan ZHANG, Qin LIU, Shan HUANG, Fan XU. Study on Sterility Test of Non-aqueous Clonazepam Injection[J]. Journal of Kunming Medical University, 2023, 44(11): 82-86. doi: 10.12259/j.issn.2095-610X.S20231112

Citation:

PDF( 679 KB)

Study on Sterility Test of Non-aqueous Clonazepam Injection

doi: 10.12259/j.issn.2095-610X.S20231112

Lu WANG¹,
Dong XIANG¹,
Yan ZHANG¹,
Qin LIU¹,
Shan HUANG²,
Fan XU^{3
,
,}

1.
Yunnan Institute For Food and Drug Control，Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform，Yunnan Kunming 650106
2.
Zhejiang TAILIN Bioengineering Co.，LTD ，Zhejiang Hangzhou 310051
3.
920 Hospital of Joint Logistic Support Force，Yunnan Kunming 650032，China

Received Date: 2023-09-01
Available Online: 2023-11-11
Publish Date: 2023-11-30

Abstract

Abstract

Objective To establish a method for sterility test of non-aqueous clonazepam injection, and explore the effect of organic solvent on sterility test. Methods With reference to the 2020 edition of Chinese Pharmacopoeia, the effects of organic solvents in Clonazepam injection on the filtration membranes and cups of different materials of the collector were investigated by membrane filtration test and membrane permeability test, as well as the effects of pH value of the sample solution and the variety and quantity of the rinsed solution on the microorganisms in the sample. Results Benzyl alcohol, acetic acid and anhydrous ethanol caused the dissolution of composite cellulose membrane, nylon membrane and PVDF membrane in different degrees, and the dissolution of composite cellulose membrane was more serious, and the benzyl alcohol remaining in the cup and filter membrane was insoluble in the medium and caused turbidity. The reaction of propylene glycol with AS cup made the medium cloudy. The pH range of the culture-medium was 5.99 ~ 7.16 after washing with different rinsing solutions. Conclusions We have developed a rational sterile testing method, which provides a good reference value for the sterile inspection of injections using organic phases as solvents.
- Clonazepam injection,
- Sterility test,
- Organic solvent,
- Collection incubator,
- Method optimization

FullText(HTML)

References(16)

References

[1]	范菲,李静静,刘鹏鸣,等. 不同厂家氯硝西泮片在4种溶出介质中溶曲线的比较[J]. 中国药业,2016,25(8):56-58.
[2]	石银涛,冯柏霖,王绘军,等. ASPE-LC-Q-TOF /MS 检测血液中氯硝西泮和 7 - 氨基氯硝西泮[J]. 药物分析杂志,2015,35(4):605-611.
[3]	余果. 6 种苯二氮类药物的联合分析及氯硝西泮在急性中毒大鼠体内的分布研究[D]. 武汉: 华中科技大学, 2013.
[4]	中华人民共和国药典[S]. 2020年版. 二部, 2020: 1649-1650.
[5]	项玮. 注射液的无菌检查方法验证的研究概况[J]. 海峡药学,2018,30(6):68-70.
[6]	杨晓莉,李辉,马英英,等. 中国药典 2015年版非无菌产品微生物限度检查: 微生物计数法解读[J]. 药物分析杂志,2016,36(6):1101-1107.
[7]	中华人民共和国药典 2020 年版. 四部[S]. 2020: 156-160.
[8]	王秀霞,顾金花,李小燕,等. 气相色谱法测定乳液中苯甲醇含量的不确定度评定[J]. 分析仪器,2022(4):33-39.
[9]	陈青连,姚振,万超. 三唑类抗真菌药物泊沙康唑注射液无菌检查方法研究[J]. 中国药业,2020,29(17):63-67.
[10]	马仕洪,肖璜,袁宇,等. 泊沙康唑注射液无菌检查方法的建立[J]. 药物分析杂志,2018,38(9):1568-1572.
[11]	刘洪祥,刘海玲,解慧,等. 注射用替加环素无菌检查的研究及优化[J]. 药物分析杂志,2020,40(8):1443-1450.
[12]	解慧,于翾,刘洪祥,等. 精蛋白重组人胰岛素注射液无菌检查方法的建立[J]. 药物分析杂志,2020,40(6):1131-1137.
[13]	马仕洪,刘鹏,杨利红,等. 药品微生物限度检查方法适用性试验中加菌方式的实验研究[J]. 药物分析杂志,2018,38(5):877-882.
[14]	解慧,刘洪祥,杨倩,等. 《美国药典》(USP42-NF37 2S)通则 <1227> 药品微生物回收的验证[J]. 中国药品标准,2020,21(2):146-149.
[15]	马仕洪,刘鹏,戴翚,等. 加替沙星无菌检查方法的建立与标准操作探讨[J]. 药物分析杂志,2007,27(6):877-880.
[16]	李康,刘旭明,朱观宇. 三联疗法治疗十二指肠溃疡的临床观察[J]. 中华全科医学,2009,7(7):720-721.

Relative Articles(20)

Relative Articles

[1]	Yongfei LI, Wenfen GAO, Jihua LIU, Yunhua ZHANG, Anbin LIU, Yuena YANG. Uncertainty Evaluation of the Determination of the Content of Ambroxol Hydrochloride Injection by Using TOP-DOWN Method. Journal of Kunming Medical University, 2024, 46(): 1-5.
[2]	Yun HUANG, Annan ZHAO, Qiuyue LIU, Weimin GAO, Ji LI. Optimization of Extraction Technology of Narciclasine from Hymenocallis Littoralis Based on Response Surface Method. Journal of Kunming Medical University, 2023, 44(11): 22-28. doi: 10.12259/j.issn.2095-610X.S20231104
[3]	Wang Lu , Liu Qin , Zhang Hong Yu , Liu Yong Hui . . Journal of Kunming Medical University, 2020, 41(05): 52-56.
[4]	Tang Xue Mei , Li Yong , Li Ting Ting . A Study of Emergency Measures and Curative Effect of Respiratory Failure Caused by Organophosphorus Pesticide Poisoning. Journal of Kunming Medical University, 2018, 39(06): 71-75.
[5]	Wu Jia , Zhao Xia , Yang Xue Fang , Hu Yue Xin , Xu Tian Yong , Duan Yong Zhong . . Journal of Kunming Medical University, 2018, 39(12): 33-37.
[6]	Wang Ying Xia , Yang Gui Mei , Hu Yan Wen , Wang Yong Yan , Yao Shan , Zhang Xuan , Zhang Li . Protective Effect of Fibrauretin Injection Against Acute Lung Injury Induced by Lipopolysaccharide in Mice. Journal of Kunming Medical University, 2016, 37(12): 12-15.
[7]	Guo Tao , Cao Juan , Wang Gang , Wang Yan Xue , Ling Feng Ying , Xia Zhi Jie . Critical Scoring Systems in the Treatment of Multiple Organ Dysfunction Due To Organic Fluorine Gas Poisoning. Journal of Kunming Medical University, 2016, 37(11): 101-104.
[8]	Hu Yue Xin . Differential Diagnosis Using Two Electrophysiological Testing Methods for Radial Tunnel Syndrome. Journal of Kunming Medical University,
[9]	Su Yan Hong . . Journal of Kunming Medical University,
[10]	Li Peng Xiang . . Journal of Kunming Medical University,
[11]	Meng Li Hong . . Journal of Kunming Medical University,
[12]	Gao Jing . . Journal of Kunming Medical University,
[13]	Yang Ming . . Journal of Kunming Medical University,
[14]	Ren Ai Hong . . Journal of Kunming Medical University,
[15]	Zhang Xue Hui . . Journal of Kunming Medical University,
[16]	Sun Mei Hong . . Journal of Kunming Medical University,
[17]	. Clinical Analysis of Trichosanthin Combined with Traditional Chinese Medicine in Treatment of Ectopic Pregnancy. Journal of Kunming Medical University,
[18]	. . Journal of Kunming Medical University,
[19]	. Clinical Experience of Acanthopanax Senticosus Injection in the Treatment of 60 Cases of Insomnia. Journal of Kunming Medical University,
[20]	Li Fu Ping . . Journal of Kunming Medical University,