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  • Ký hiệu PL/XG: 615
    Nhan đề: Nghiên cứu bào chế dung dịch tiêm Mesna 10% /
DDC 615
Tác giả CN Đào, Nguyệt Sương Huyền
Nhan đề Nghiên cứu bào chế dung dịch tiêm Mesna 10% / Đào Nguyệt Sương Huyền, Lữ Nguyễn Phúc Hưng, Nguyễn Đình Luyện, Nguyễn Văn Hân
Tóm tắt In view that mesna is commonly indicated for urothelial intoxication (as uroprotector) in patients treated with ifosfamide and cyclophosphamide, but its injection dosage forms currently used in Viet Nam are all imported, a solution of mesna 10% for injection was formulated and prepared with disodium edetate as excipient. Mesna (10%) and disodium edetate (0.25 mg/ml) were dissolved in water, adjusted to pH 7.4 with NaOH 1.0N. Dissolved oxygen was removed by nitrogen purging, and finally sterilized at 121°C/15 minutes in an autoclave. For quality control, the obtained solutions were quantitatively analyzed by PPLC. The quantitative procedure was validated to meet the conventional requirements as specificity, linearity (0.25-0.75 mg/ml), precision (RSD < 2%) and accuracy (99.77-101.60%). Study on the stability proved the the obtained mesna injections remained stable after 12 months’ storage at either 40 ± 2 °C (75 ± 5% relative humidity) or 30 ± 2 °C (75 ± 5% relative humidity).
Thuật ngữ chủ đề Nghiên cứu kỹ thuật --Việt Nam
Từ khóa tự do Bào chế
Từ khóa tự do Mesna
Tác giả(bs) CN Lữ, Nguyễn Phúc Hưng
Nguồn trích Tạp chí Dược học 2018tr. 63-67 Số: 07
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00118716
0029
0049774F9D7-91D5-4204-883A-A73CC7B57332
005201912061517
008081223s vm| vie
0091 0
039|y20191206151704|zthienvan
082 |a615
100 |aĐào, Nguyệt Sương Huyền
245 |aNghiên cứu bào chế dung dịch tiêm Mesna 10% / |cĐào Nguyệt Sương Huyền, Lữ Nguyễn Phúc Hưng, Nguyễn Đình Luyện, Nguyễn Văn Hân
520 |aIn view that mesna is commonly indicated for urothelial intoxication (as uroprotector) in patients treated with ifosfamide and cyclophosphamide, but its injection dosage forms currently used in Viet Nam are all imported, a solution of mesna 10% for injection was formulated and prepared with disodium edetate as excipient. Mesna (10%) and disodium edetate (0.25 mg/ml) were dissolved in water, adjusted to pH 7.4 with NaOH 1.0N. Dissolved oxygen was removed by nitrogen purging, and finally sterilized at 121°C/15 minutes in an autoclave. For quality control, the obtained solutions were quantitatively analyzed by PPLC. The quantitative procedure was validated to meet the conventional requirements as specificity, linearity (0.25-0.75 mg/ml), precision (RSD < 2%) and accuracy (99.77-101.60%). Study on the stability proved the the obtained mesna injections remained stable after 12 months’ storage at either 40 ± 2 °C (75 ± 5% relative humidity) or 30 ± 2 °C (75 ± 5% relative humidity).
650 |aNghiên cứu kỹ thuật |zViệt Nam
653 |aBào chế
653 |aMesna
700 |aLữ, Nguyễn Phúc Hưng
773 |tTạp chí Dược học |d2018|gtr. 63-67|i07
890|c1|a0|b0|d5
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