National Institute for Research in Tuberculosis (Indian Council of Medical Research), Chennai, India.
Bill and Melinda Gates Foundation, New Delhi, India.
Trop Med Int Health. 2013 Sep;18(9):1141-1144. doi: 10.1111/tmi.12158.
To determine the content of certain antituberculosis (TB) drugs supplied at TB treatment centres of the Revised National TB Control Programme (RNTCP) in the state of Tamil Nadu, India.
Eight districts across the state were selected, and the following drugs were collected from five settings (District TB centre, TB unit, designated microscopy centres, DOT providers) in each district: rifampicin (150 and 450 mg), isoniazid (300 mg), pyrazinamide (500 and 750 mg), ethambutol (400 and 600 mg), ethionamide (250 mg), levofloxacin (500 mg) and cycloserine (250 mg). A maximum of 10 tablets/capsules were collected from each setting. The drugs were coded prior to analysis. All drugs were assayed by validated spectrophotometric methods. The acceptable limits for drug content were taken as 90-110% of the stated content.
More than 90% of tablets of rifampicin 450 mg, isoniazid 300 mg, pyrazinamide 500 and 750 mg, ethambutol 400 and 600 mg and ethionamide 250 mg were within acceptable limits. Eighty per cent of rifampicin 150 mg, 21% of cycloserine 250 mg and 87% of levofloxacin 500 mg were within acceptable limits. The mean cycloserine content was below the acceptable limit in all districts, the mean drug content being 200 mg (range: 108-245 mg).
This systematic study showed that the stated drug content of cycloserine was not reached in all districts. Deterioration of cycloserine could be minimised by storing the drug in refrigerators. The geographical location of the districts had no influence on the drug content.
确定印度泰米尔纳德邦修订国家结核病控制规划(RNTCP)结核病治疗中心供应的某些抗结核(TB)药物的含量。
从该邦的 8 个地区中选取了 5 个地区(地区结核病中心、结核病单位、指定显微镜中心、DOT 提供者),从每个地区的 5 个设置中收集了以下药物:利福平(150 和 450mg)、异烟肼(300mg)、吡嗪酰胺(500 和 750mg)、乙胺丁醇(400 和 600mg)、乙硫异烟胺(250mg)、左氧氟沙星(500mg)和环丝氨酸(250mg)。每个设置最多收集 10 片/胶囊。在分析之前对药物进行编码。所有药物均通过验证的分光光度法进行测定。药物含量的可接受限度为规定含量的 90-110%。
超过 90%的利福平 450mg、异烟肼 300mg、吡嗪酰胺 500 和 750mg、乙胺丁醇 400 和 600mg 和乙硫异烟胺 250mg 片剂在可接受范围内。80%的利福平 150mg、21%的环丝氨酸 250mg 和 87%的左氧氟沙星 500mg 在可接受范围内。所有地区的环丝氨酸平均含量均低于可接受限度,平均药物含量为 200mg(范围:108-245mg)。
这项系统研究表明,并非所有地区的环丝氨酸含量都达到了规定的标准。通过将药物储存在冰箱中,可以最大限度地减少环丝氨酸的变质。地区的地理位置对药物含量没有影响。