复方骨质增生缓释片含量测定和体外释放度研究  

Study on Content Determination of Compound Anti-hyperosteogeny Sustained-release Tablets and In-vitro Release Degree

作　　者：余利军[1] 施星臣[2] 李晓强[3] 张伟[4] YU Lijun;SHI Xingchen;LI Xiaoqiang;ZHANG Wei(Gansu Provincial Hospital,Lanzhou 730000,China;The Second People's Hospital of Lanzhou City;Lanzhou University Second Hospital;Gansu Provincial Rehabilitation Central Hospital)

机构地区：[1]甘肃省人民医院,甘肃兰州730000 [2]兰州市第二人民医院 [3]兰州大学第二医院 [4]甘肃省康复中心医院

出　　处：《西部中医药》2020年第3期45-48,共4页Western Journal of Traditional Chinese Medicine

基　　金：甘肃省青年科技基金(1506RJYA315)。

摘　　要：目的:制定复方骨质增生缓释片的含量测定方法并考察其体外释放度。方法:采用高效液相色谱法(high performance liquid chromatography,HPLC)对复方骨质增生缓释片中金丝桃苷和槲皮素进行含量测定方法学研究;采用正交实验,以金丝桃苷和槲皮素的释放为指标,优选制备工艺,并进行体外累积释放度测定。结果:色谱柱为Agilent Eclipse XDB-C18(250 mm×4.6 mm,5μm);流动相:乙腈(A)-0.1%磷酸水溶液(B),梯度洗脱条件:0~18 min,14.5%A;18~60 min,14.5%~25.0%A。检测波长:360 nm;柱温:30℃;流速:1.0 mL/min;该测定条件下金丝桃苷和槲皮素浓度分别在3.44~50.04μg/mL和3.74~59.90μg/mL,线性范围内呈良好线性关系。方法学稳定。复方骨质增生缓释片中每片含金丝桃苷(8.62±0.43)μg,槲皮素(10.38±0.58)μg。优化的复方骨质增生缓释片处方为羟丙基甲基纤维素36 g,乳糖24 g,微晶纤维素20 g,所得缓释片体外释药曲线符合缓释制剂的要求。结论:复方骨质增生缓释片含量测定方法快捷简便、稳定、可靠,处方工艺简单可行,缓释效果明显。Objective: To establish the method of detecting the contents of compound anti-hyperosteogeny sustained-release tablets and investigate its in-vitro release degree. Methods: HPLC method was used to perform content methodology research for hyperin and quercetin in compound anti-hyperosteogeny sustained-release tablets;orthogonal experiment was adopted to optimize the preparation technology amd detect in-vitro cumulative release degree by taking the release of hyperin and quercetin as the indexes. Results: Agilent Eclipse XDB-C18(250 mm ×4.6 mm, 5 μm);mobile phase: acetonitrile(A)-0.1% phosphoric acid aqueous solution(B), the conditions for gradient elution were: 0~18 min, 14.5%A: 18~60 min, 14.5%~25.0%A. Detection wavelengthen: 360 nm;column temperature:30℃;flow rate: 1.0 mL/min;hyperin and quercetin presented good linear relationship in the range from 3.44 to 50.04 μg/mL and from 3.74 to 59.90 μg/mL under the detection conditions. The methodology was stable. Each of compound anti-hyperosteogeny sustained-release tablets contained hyperin(8.62±0.43)μg and quercetin(10.38±0.58)μg.The optimized prescription of compound anti-hyperosteogeny sustained-release tablet was HPMC 36 g, lactin 24 g and MCC 20 g. In-vitro release curve of the tablets met the requirements of the preparations. Conclusion: The method for content determination of compound anti-hyperosteogeny sustained-release tablets is rapid, convenient,stable and reliable, the formulation process is simple and feasible and it shows notable delayed-release effects.

关 键 词：复方骨质增生缓释片 含量测定 体外释药 

分 类 号：R921[医药卫生—药学]