Xây dựng công thức bào chế viên nén diltiazem 120 mg tác dụng kéo dài với tá dược gôm xanthan

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Tác giả: Thông Liêm Lôi, Thị Hoài Thương Nguyễn

Ngôn ngữ: vie

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Thông tin xuất bản: Tạp chí Khoa học và Công nghệ - Đại học Nguyễn Tất Thành, 2022

Mô tả vật lý: tr.54

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ID: 335808

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Diltiazem hydrochloride, a benzothiazepine derivative, is considered a safe and effective antihypertensive agent. The drug also has the advantage of having no side effects on kidneys and not causing metabolic disorders. However, a major drawback of diltiazem is that the half-life is only about 6 hours, so patients have to take the drug 3 to 4 times a day. In order to overcome the disadvantages of conventional tablets, the study has developed a sustained-release diltiazem tablet formulation with hydrophilic matrix system by wet granulation method using release control excipients such as xanthan gum and hydroxy propyl methyl cellulose (HPMC). The best formulation was obtained with diltiazem 120 mg and excipients: xanthan gum (50 mg), HPMC (20 mg), lactose (100 mg), Amidon (40 mg), Comprecel (70 mg), talc and magnesium stearate 2 % (ratio 1:1). The study also prepared and evaluated some basic quality standards of sustained-release diltiazem 120 mg tablets, as well as controlled drug release up to 8 hours ( not less than 65 %).Diltiazem hydroclorid, là một dẫn xuất benzothiazepin, được coi là thuốc điều trị tăng huyết áp an toàn và hiệu quả, không có tác dụng không mong muốn ở thận và không gây rối loạn chuyển hóa. Tuy nhiên, nhược điểm lớn nhất của diltiazem là thời gian bán thải chỉ khoảng 6 giờ do vậy người bệnh phải sử dụng thuốc 3 đến 4 lần một ngày. Để khắc phục các nhược điểm của viên quy ước, nghiên cứu đã tiến hành xây dựng công thức bào chế viên nén diltiazem tác dụng kéo dài với hệ cốt thân nước bằng phương pháp xát hạt ướt sử dụng các tá dược kiểm soát giải phóng chính là gôm xanthan và hydroxy propyl methyl cellulose (HPMC). Công thức bào chế tốt nhất thu được với hàm lượng diltiazem 120 mg và các tá dược gôm xanthan (50 mg), HPMC (20 mg), lactose (100 mg), amidon (40 mg), comprecel (70 mg), talc và magnesi stearat 2 % (tỉ lệ 1:1). Nghiên cứu cũng đã tiến hành bào chế và đánh giá được một số tiêu chuẩn chất lượng cơ bản của viên nén diltiazem 120 mg tác dụng kéo dài để từ đó đề xuất các chỉ tiêu chất lượng cơ bản cũng như khả năng kiểm soát giải phóng dược chất lên đến 8 giờ (không dưới 65 %).

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