Comparison of generic zidovudine + lamivudine (Cipla, Duovir) and the GlaxoSmithKline brand (Combivir) tablets.

Comparison of generic zidovudine + lamivudine (Cipla, Duovir) and the GlaxoSmithKline brand (Combivir) tablets.
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通用齐多夫定拉米夫定(Cipla,Duovir)和葛兰素史克品牌(Combivir)片剂的比较。

DOI:
10.1097/00126334-200404150-00012
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发表时间:
2004
期刊:
Journal of acquired immune deficiency syndromes (1999)
影响因子:
--
通讯作者:
Shet,Anita
Shet,Anita
中科院分区:
--
文献类型:
--
作者:
Henry,Keith;Brundage,Richard;Weller,Dennis;Akinsete,Omobosola;Shet,Anita

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艾滋病毒/艾滋病流行病已经造成估计2 400万人死亡,目前有4 000万人受到感染。有效的抗逆转录病毒治疗可以显着改善艾滋病毒感染的临床过程,但由于其成本,其使用非常有限。非专利抗逆转录病毒药物的价格比品牌药物低97%。1最近,一名患者在海外开始一个疗程的通用齐多夫定(AZT)+3 TC(拉米夫定)(Duovir,Cipla)治疗后返回明尼阿波利斯,继发于可能的艾滋病毒性暴露。评价显示药物的副作用和HIV传播的低风险,因此治疗被中断。由于关于仿制抗逆转录病毒药物纯度的数据很少,明尼苏达大学抗病毒药理学实验室对Duovir与Combivir(葛兰素史克)的化学纯度进行了评价。使用美国药典(USP)AZT片剂指南(USP 24-NF 19)中的程序,分析了Combivir(AZT 300 mg +3 TC 150 mg/胶囊; Glaxo-Smith-Kline批号1 ZP 2346)和Duovir(AZT 300 mg+3 TC 150 mg/胶囊; Cipla批号C10237)各一片的AZT和3 TC含量。独立制备分析标准品和各制剂的溶液,以达到3 TC的最终浓度为1.25 µg/mL,AZT的最终浓度为2.50 µg/mL。高效液相色谱
The HIV/AIDS epidemic has already killed an estimated 24 million people, with 40 million currently infected. Potent antiretroviral therapy can significantly improve the clinical course of HIV infection, but its use has been very limited due to its cost. Generic antiretroviral medications are available at a cost as low as 97% less than brand name drugs. 1 Recently, a patient returned to Minneapolis after initiating a course of generic zidovudine (AZT)+ 3TC (lamivudine)(Duovir, Cipla) overseas secondary to a possible sexual exposure to HIV. Evaluation revealed adverse effects attributable to the medications and a low risk for HIV transmission so treatment was discontinued.Because few data have been published regarding the purity of generic antiretroviral medications, an evaluation of the chemical purity of Duovir compared to Combivir (GlaxoSmithKline) was performed at the University of Minnesota Antiviral Pharmacology Laboratory. One tablet each of Combivir (AZT 300 mg+ 3TC 150 mg/capsule; Glaxo-Smith-Kline lot# 1ZP2346) and Duovir (AZT 300 mg+ 3TC 150 mg/capsule; Cipla lot# C10237) were analyzed for AZT and 3TC content using a procedure derived from United States Pharmacopeia (USP) guidelines for AZT tablets (USP 24-NF19). Solutions from analytical standards and each drug product were independently prepared to achieve final concentrations of 1.25 µg/mL for 3TC and 2.50 µg/mL for AZT. Highperformance liquid chromatographic
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发表时间: 2001
期刊:
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