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Truy cập
Đang online: 12
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CHI TIẾT
Nghiên cứu bào chế pellet verapamil hydroclorid giải phóng kéo dài
Preparation of sustained-release pellets of verapamil hydrochloride
Phạm Văn Hùng, Trương Đức Mạnh, Nguyễn Thị Thanh Duyên, Trần Thị Hải Yến, Nguyễn Thị Hiền
Số: 528 - Tháng 4/2020 - Trang 29-34, 40

Verapamil hydroclorid (VH) là một thuốc chẹn kênh calci, được dùng để điều trị đau thắt ngực, tăng huyết áp và rối loạn nhịp tim. VH hấp thu tốt qua đường tiêu hóa (khoảng 90 %), nhưng sinh khả dụng chỉ đạt khoảng 20 35 % do chuyển hóa bước đầu qua gan nhanh. VH có thời gian bán thải ngắn (khoảng 2 - 8 giờ) nên bệnh nhân phải uống nhiều lần trong ngày. Do đó, nghiên cứu bào chế dạng thuốc verapamil giải phóng kéo dài có nhiều ý nghĩa, giúp duy trì nồng độ điều trị của thuốc trong máu thời gian dài nên giảm số lần dùng thuốc trong ngày, giúp bệnh nhân tuân thủ phác đồ điều trị, nâng cao hiệu quả điều trị. Ở Việt Nam, dạng thuốc giải phóng kéo dài chứa verapamil còn ít được nghiên cứu, đặc biệt là dạng viên nang chứa pellet giải phóng kéo dài, chúng tôi tiến hành đề tài “Nghiên cứu bào chế pellet verapamil hydroclorid giải phóng kéo dài” với mục tiêu nghiên cứu bào chế pellet verapamil hydroclorid giải phóng kéo dài 24 giờ.

Nguyên liệu

Verapamil hydroclorid (Trung Quốc), lactose monohydrat (Đài Loan), Avicel PH102 (Đài Loan), hydroxylpropyl methylcellulose (HPMC) E5, E6 và E15 (Trung Quốc), talc (Trung Quốc), dibutyl phthalat (DBP) (Đức), ethyl cellulose (EC) N7 và N20 (Mỹ), và các tá dược hóa chất khác đạt tiêu chuẩn dược dụng và tinh khiết hóa học.

Phương pháp nghiên cứu

- Phương pháp bào chế pellet VH nhân.

- Phương pháp bào chế pellet VH giải phóng kéo dài.

- Phương pháp đánh giá.

- Phương pháp đánh giá mô hình động học giải phóng dược chất từ dạng bào chế.

Kết luận

Như vậy, nghiên cứu đạt được mục tiêu xây dựng được công thức và các thông số kỹ thuật bào chế pellet VH giải phóng kéo dài. Nghiên cứu cũng đã đề xuất một số chỉ tiêu chất lượng cho pellet thực nghiệm gồm: độ ẩm, tốc độ chảy, khối lượng riêng biểu kiến, hàm lượng VH và khả năng giải phóng dược chất sau 2, 4, 8 và 24 giờ. Chế phẩm nghiên cứu có kết quả thử hòa tan đạt tiêu  chuẩn theo USP 41 và có mô hình giải phóng tương đồng với chế phẩm đối chiếu với hệ số f2 đạt 71,1.

Sustained-release pellets of verapamil hydroclorid (VH) were was to prepared through two stages: preparation of VH core pellets by extrusion-spheronization and then controlled-release coats with fluid bed coater. VH core pellets getting standard qualities were coated with a controlled-release membrane of ethyl cellulose (EC), hydroxylpropyl methylcellulose (HPMC), talc and dibutyl phthalat (DBP). The folowing formulation factors of the controlled-release membrane were investigated: Type of EC and HPMC, ratio of HPMC to EC, plasticizer (DBP)-polymer ratio. The formulaled VH sustained-release pellets proved to meet the dissolution test requirements by USP 41 and the same as the reference pellets in dissolution profile (similarity factor f2 = 71.1).

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