Uji Perbandingan Penetapan Kadar Sediaan Tablet Allopurinol 300 mg Generik dengan Nama Dagang Beredar di Distrik Sentani, Jayapura

Rusnaeni Rusnaeni, E. S. Simaremare
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Abstract

Allupurinol is a medicine to treat gout especially to minimize the quantity of uric acid inside human blood. This study aims to understand the quality of gout drugs particularly the standard of Allupurinol between generic 300 mg and others Allupurinol tablet in retails at Jayapura Regency. Survey method has been used and samples were collected from Sentani district, Jayapura Regency. Spectrophotometer was used to determine the rate of Allupurinol. The results proved that in Allupurinol generic (A) the rate was 100.28% and generic (B) was 99.044%. For others tablet non generic with naming (a) the rate of Allupurinol as 99.46% while (b) was 100.77%. It means the averages of Allupurinol contain in generic was 99.6% and non-generic was 100.12%. According to Indonesian Farmakope Manual 4th Edition, the rate of Allupurinol contains in a drug must be 93.0% for minimum and can’t be more than 107.0%. Our study shown that Allupurinol generic with (A) label and non-generic with (b) label are based on the Indonesian Farmakope Standard 4th Edition.  Key words: Tablet Allopurinol, Penetapan generik, Jayapura.  
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磺胺嘌呤醇是一种治疗痛风的药物,尤其能减少人体血液中的尿酸含量。本研究旨在了解痛风药物的质量,特别是在Jayapura Regency零售的300 mg仿制药和其他Allupurinol片剂之间的差异。采用调查方法,从查亚普拉县森塔尼区收集样本。用分光光度法测定绿嘌呤醇的收率。结果表明,绿嘌呤醇仿制药(A)的提取率为100.28%,仿制药(B)的提取率为99.044%。其他非仿制片剂(a)溶出率为99.46%,(b)溶出率为100.77%。即仿制药中铝尿醇的平均含量为99.6%,非仿制药中铝尿醇的平均含量为100.12%。根据印尼《农业手册》第4版规定,药品中Allupurinol的含量最低为93.0%,不能超过107.0%。我们的研究表明,具有(A)标签的Allupurinol仿制药和具有(b)标签的非仿制药基于印度尼西亚Farmakope标准第4版。【关键词】别嘌呤醇片剂;Penetapan generic;
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