Giám sát chất lượng thuốc chống nhiễm trùng tại một số tỉnh ở việt nam năm 2011

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Tác giả: Thị Sáu Bùi, Minh Đạo Lê, Mạnh Hùng Nguyễn, Thị Minh Thu Nguyễn, Thị Minh Thịnh Phạm, Thị Tĩnh Tạ

Ngôn ngữ: vie

Ký hiệu phân loại: 615.7 Pharmacokinetics

Thông tin xuất bản: Tạp chí Phòng chống sốt rét và các bệnh ký sinh trùng, 2012

Mô tả vật lý: 29-35

Bộ sưu tập: Metadata

ID: 628175

This study was conducted between March and October, 2011 in 11 provincial sites of Vietnam including Ha Giang, Dien Bien, Thanh Hoa, Quang Tri, Binh Dinh, Cao Bang, Bac Kan, Nghe An, Ha Tinh, Quang Binh and Binh Phuoc. Total of 589 anti-infective medicine samples (of which with 307 available anti-malarials, 59 anti-tuberculosis, 13 anti-retroviral drugs and 210 selected antibiotics) were colected from public and rivate health facilities. All of colected samples were screen analized by GPHF-minilab kits at sentinel sites and NIMPE according to GPHF monographs for specifications of visual and physical inspections, disintergration tests and thin layer chromatography assays. CV artecan film coated tables (code 96R1.10, OPC pharmaceutical JSC., lot 00108, expiry date in December 2011, collected from a public medical station in Quang Tri province) had both failed visual inspection and disintegration tests with yellow coated film differentiating from their green coated film as in its internal criterion and no disintegration (only bloating). CVartecan 96R1.10 and 5 percent of randomly chosen samples were sent to National Institute of Drug quality control (NIDQC) for comjirmatory tests. The results showed that: except CV artecan 96R1.10 sample, Mekofan tablets (code 380R1.10, Mekophar pharmaceutical JSC., lot 08001AN, expiry date in December 2012, collecetedform a private pharmacy in Dien Bien province was found as a substandard drug by confirmatory test but Minilab test. Mikofan did not pass dissolution test with failed pyrimethamine dissolution. Generally, two antimalarial drugs were found as substandard drugs, rated 0.34 percent (2/589) of total samples and 0.65 percent (2/307) of altimalarials, in which CV artecan 96R1.10 substandard sample might be due to being stored in not good conditions.
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