Xây dựng quy trình định lượng acid asperulosidic trong thuốc bột từ bài thuốc hỗ trợ điều trị thoái hóa cột sống của lương y Nguyễn Thiện Chung bằng phương pháp HPLC

0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Trần Quốc Dũng Huỳnh, Đức Hạnh Nguyễn, Hữu Mai Lynh Nguyễn, Ngọc Thạc Phạm, Thanh Dũng Phan, Thanh Hóa Võ

Ngôn ngữ: vie

Ký hiệu phân loại: 615.32 Drugs derived from plants and microorganisms

Thông tin xuất bản: Khoa học & công nghệ Việt Nam, 2022

Mô tả vật lý: 31 - 35

Bộ sưu tập: Metadata

ID: 500030

Thêm vào giỏ

Bài thuốc hỗ trợ điều trị thoái hóa cột sống của lương y Nguyễn Thiện Chung (gọi là BT) gồm 13 vị thuốc đã được chứng minh có tác dụng giảm đau, kháng viêm trên động vật và đã được phát triển thành dạng thuốc bột. Nghiên cứu này được thực hiện nhằm xây dựng phương pháp định lượng acid asperulosidic, chất điểm chỉ trong thuốc bột BT, bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC). Các điều kiện xử lý mẫu thử và điều kiện HPLC định lượng được nghiên cứu lựa chọn. Quy trình định lượng đã được thẩm định theo hướng dẫn của Hội đồng quốc tế về hài hòa các yêu cầu kỹ thuật đối với dược phẩm dùng cho người (ICH) về tính tương thích hệ thống, độ đặc hiệu, tính tuyến tính, độ chính xác và độ đúng. Methanol được chọn làm dung môi để chuẩn bị mẫu thử và tỷ lệ giữa thuốc bột BT và methanol là 300:25 (mg/ml). Điều kiện HPLC được chọn để định lượng acid asperulosidic gồm cột C18 Shimpack GIST (250×4,6 mm, 5 μm), bước sóng phát hiện 236 nm, nhiệt độ cột 30oC, tốc độ dòng 1 ml/phút và thể tích tiêm 10 μl. Pha động là hỗn hợp của acetonitril và H3 PO4 0,1% với tỷ lệ 9,5:90,5 (tt/tt). Phương pháp định lượng cho thấy sự tương quan tuyến tính cao giữa diện tích pic và nồng độ acid asperulosidic (r2=0,9987). Giá trị độ lệch chuẩn tương đối (RSD) của độ chính xác trung gian là 1,24%. Tỷ lệ phục hồi trong khoảng 91,22-99,76%. Quy trình định lượng acid asperulosidic trong thuốc bột BT đáp ứng các yêu cầu thẩm định và có thể được áp dụng để xây dựng tiêu chuẩn và theo dõi chất lượng của thuốc bột BT.Nguyen Thien Chung's remedy which consists of 13 medicinal herbs had been demonstrated its analgesic and anti-inflammatory effects on animal experiments. This remedy has further been developed into powder form. This study was conducted to develop a method to quantify asperulosidic acid, the important marker in BT powder, by high-performance liquid chromatography (HPLC). Sample processing conditions and quantitative HPLC conditions were screened. The HPLC method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for system suitability, specificity, linearity, precision and accuracy. Methanol was chosen as the solvent for sample preparation and the ratio between BT powder and methanol was 300:25 (mg/ml). The selected HPLC conditions included a C18 Shimpack GIST column (250×4.6 mm, 5 μm), a detection wavelength of 236 nm, a column temperature of 30oC, a flow rate of 1 ml/min, and an injection volume of 10 μl. The mobile phase was a mixture of acetonitrile and 0.1% H3 PO4 with a ratio of 9.5:90.5 (v/v). The quantitative method showed a good linear correlation between the peak area and the concentration of asperulosidic acid (r2=0.9987). The Relative standard deviation (RSD) value of the intermediate precision was 1.24%. The recovery was found in a range of 91.22-99.76%. The HPLC method for asperulosidic acid quantification in BT powder met the validation requirements and could be applied to standardise and evaluate the quality of BT powder.

1. Đọc trực tuyến

1. Đọc trực tuyến

Tạo bộ sưu tập với mã QR