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目的:考察激光打孔的孔径与释放条件对自制益智方渗透泵片体外释放的影响。方法:处方量主药与辅料混合均匀,70%乙醇制粒、压片、包衣,衣膜增重7%,熟化,激光打孔器双面打孔,制备孔径为0.2、0.4、0.6、0.8、1.0mm激光打孔片剂。考察不同测定方法(转篮法、桨法)、不同孔径、不同转速、不同渗透压条件下释放度,并比较4种有效成分(人参皂苷Rg1、人参皂苷Rb1、人参皂苷R1、桅子苷)释放度,探索其释放规律。结果:转篮法测定该渗透泵片,释放度重复性较好;激光打孔孔径为0.2-0.6mm时,近恒速释放;在50r/min转速条件下,0.4mm孔径片中4种成分12h累积释放度均达到了85%以上;释药度随着释放介质渗透压的升高而减少;4种检测成分间释放度相似因子均大于50;0.4mm孔径,转篮法50r/min条件下,10h释放较符合零级释放方程y=9.1034t+4.5482(r=0.9915)。结论:转篮法适于测定益智渗透泵片的释放度,激光打孔孔径对释放度有一定影响,衣膜内外渗透压是片剂释放动力,4种有效成分释放度相似,该制剂的释放符合零级释放方程。
OBJECTIVE: To investigate the influence of laser drilling aperture and release conditions on the in vitro release of self-made Zhibi square osmotic pump tablets. Methods: Prescription amount of the main drug and auxiliary materials were mixed uniformly, 70% ethanol granulation, tabletting, coating, coat weight gain 7%, ripening, double hole punching by laser drilling, preparation of aperture 0.2,0.4,0.6, 0.8,1.0 mm laser drilling tablets. The effects of different assay methods (spin basket method, paddle method), different pore sizes, different rotational speeds and different osmotic pressure were investigated. Four active ingredients (ginsenoside Rg1, ginsenoside Rb1, ginsenoside R1, pedidoidin) Release degree, explore its release law. Results: The osmotic pump tablets were determined by spin basket method, and the repeatability was good. When laser drilling aperture was 0.2-0.6mm, nearly constant speed was released. Under the speed of 50r / min, the four components 12h cumulative release rate reached more than 85%; release of drug with the release of media to increase the osmotic pressure and reduce the release of four kinds of test components similarity greater than 50; 0.4mm aperture, basket method 50r / min conditions , The release of 10h is more consistent with the zero-order release equation y = 9.1034t + 4.5482 (r = 0.9915). Conclusion: The spin-basket method is suitable for the determination of the release rate of the puzzle osmotic pump. The aperture of the laser drilling has certain influence on the release degree. The osmotic pressure inside and outside the film is the release force of the tablet, and the release of the four active ingredients is similar. Release meets the zero-order release equation.