今日药学

2020, v.30(10) 678-682

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梅归参鼻用温敏型原位凝胶的制剂学评价
Quality Evaluation of Meiguishen Nasal Thermosensitive In-Situ Gel

徐文杰;张建军;李智勇;陈雪婷;王洛临;
XU Wenjie;ZHANG Jianjun;LI Zhiyong;CHEN Xueting;WANG Luolin;Guangdong Second Traditional Chinese Medicine Hospital,Guangdong Province Engineering Technology Research Institute of Traditional Chinese Medicine,Guangdong Provincial Key Laboratory of Research and Development in Traditional Chinese Medicine;

摘要(Abstract):

目的制备梅归参鼻用温敏型原位凝胶并进行制剂学评价。方法在梅归参提取物的基础上加入温敏凝胶基质制成鼻用温敏型原位凝胶。采用HPLC法测定原位凝胶中盐酸小檗碱的含量,采用扩散池法考察原位凝胶体外释药行为,采用试管倒置法测定胶凝温度,采用90°试管倾斜法胶凝时间,采用黏度计测定原位凝胶的黏度,采用位移法测定其黏附力,采用p H计测定其p H值,采用离心法考察其均一性。结果制备的梅归参鼻用温敏型原位凝胶中盐酸小檗碱含量为1.37 mg·g-1,8 h盐酸小檗碱累积释药率达到95%,且3批样品之间盐酸小檗碱的含量及释放度无差异。凝胶在33.5℃下于15 s内胶凝,p H值为5.8,均一性良好。结论所制备的梅归参鼻用温敏型原位凝胶在室温下各方面性质均稳定、均一,批间差异较小,制备工艺的重现性较好。
OBJECTIVE To prepare the Meiguishen nasal thermosensitive in-situ gel and evaluate the quality of it. METHODS Thermosensitive in-situ gel was prepared for nasal use and added to extract of Meiguishen. HPLC was used to determine the content of berberine hydrochloride in the Meiguishen nasal thermosensitive in-situ gel. The diffusion method was used to study the in vitro release characteristics. The gelation temperature was measured by tube inversion method. The gelation time was measured by 90 degree tube tilt method. The viscosity of in-situ gel was measured by viscometer. Displacement method was used to determinethe adhesive force of gel.The pH value was determined by pH meter,and the centrifuge method was used to study the homogeneity of in-situ gel. RESULTS The content of berberine hydrochloride in the sample was 1. 37 mg·g~(-1). The cumulative release rate of berberine hydrochloride were reached 95% after 8 h. And there was no difference in the content and dissolution degree of berberine hydrochloride among the three samples. Meiguishen nasal thermosensitive in-situ gel was gelatinization at 33. 5℃ in 15 s, and the p H value was 5. 8, and itshomogeneity was good. CONCLUSION The quality of Meiguishen nasal thermosensitive in-situ gel is stable and homogeneous.There is little difference among three groups. The preparation process has good reproducibility.

关键词(KeyWords): 原位凝胶;理化性质;体外释放;制剂学评价
in-situ gel;characteristics;release in vitro;preparation evaluation

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基金项目(Foundation): 广东省中医药局建设中医药强省科研项目(20161015);; 广东省省级科技计划项目(2017A070701017);; 广东省中医药科技创新平台建设项目(粤中医函[2018]6号)

作者(Author): 徐文杰;张建军;李智勇;陈雪婷;王洛临;
XU Wenjie;ZHANG Jianjun;LI Zhiyong;CHEN Xueting;WANG Luolin;Guangdong Second Traditional Chinese Medicine Hospital,Guangdong Province Engineering Technology Research Institute of Traditional Chinese Medicine,Guangdong Provincial Key Laboratory of Research and Development in Traditional Chinese Medicine;

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