参白药效部位纳米混悬剂的剂型工艺优化及其升白作用的研究  

Studies on the optimization of preparation process of Shenbai nanosuspension based on effective parts and the effect of increasing leukocyte

作　　者：简凤娇 郭敏 吴沛杭 李孝栋[1] JIAN Fengjiao;GUO Min;WU Peihang;LI Xiaodong(School of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China)

机构地区：[1]福建中医药大学药学院,福建福州350122

出　　处：《药学研究》2022年第6期378-383,共6页Journal of Pharmaceutical Research

基　　金：福建省高校产学合作项目(No.2021Y4016)。

摘　　要：目的优化参白方有效部位纳米混悬剂的制备工艺,并开展纳米混悬剂的表征和升高白细胞的药效研究。方法以参白方总多糖和总皂苷混合物为药物原料,在单因素考察的基础上,通过高压均质法,以稳定剂用量、均质压力、均质次数为影响因素,开展参白有效部位纳米混悬剂剂型工艺的正交优化和沉降稳定的观察,对制得的纳米混悬剂进行表征和升高白细胞的药效试验。结果参白有效部位纳米混悬剂最优剂型工艺为:药物与大豆卵磷脂质量比为1∶1.75,均质压力700 bar,均质次数14次。测得纳米混悬剂的粒径为(277.3±2.17)nm,PDI为(0.185±0.018),Zeta电位为(-32.50±0.86)mV。给药7 d后,与模型组比较,给药7 d后纳米混悬剂高剂量组白细胞水平显著升高,给药15 d各剂量组白细胞水平显著升高(P<0.05)。结论参白有效部位纳米混悬剂的剂型优化工艺合理、可行,制剂粒径符合纳米要求,分散均匀且稳定,具有较好的升白作用,为有效部位组成的中药纳米混悬剂的新药研究提供有益的启示。Objective To optimize the preparation process of nanosuspension based on the effective parts of Shenbai formulation,and characterize the nanosuspension,and study the efficacy of increasing leukocyte.Methods The total polysaccharides and total saponins in Shenbai formulation were selected as the effective part of Shenbai nanosuspension.On the basis of single factor investigations,taking the stabilizer dosage,homogenization pressure and homogenization times as the influencing factors,the orthogonal optimization of the preparation process of Shenbai nanosuspension was carried out by the high-pressure homogenization method.Concurrently,settlement stability was observed.And the prepared nanosuspension was characterized and the efficacy test of increasing leukocytes was researched.Results The optimal preparation process of Shenbai effective part nanosuspension was as follows:the mass ratio of drug to soybean lecithin 1∶1.75,the homogenization pressure 700 bar,and the homogenization times with 14 times.The particle size of the nanosuspension was(277.3±2.17)nm,and the PDI was(0.185±0.018)with the Zeta potential(-32.50±0.86)mV.Compared with the model group,after 7 days of administration,the level of leukocytes in the high-dose SBEP-NS group increased significantly,and after 15 days,the level of leukocytes in each dose group increased significantly(P<0.05).Conclusion The preparation process of Shenbai effective part nanosuspension was reasonable and feasible.The particle size in the suspension meets nanoparticle requirement with an uniform dispersion and good stability.Meanwhile,the nanosuspension has a positive effect in increasing leukocyte.In a word,the paper provides useful enlightenment for the new drug research of traditional Chinese medicine nanosuspension composed of effective parts.

关 键 词：参白方有效部位 纳米混悬剂 剂型工艺 正交试验 升白作用 

分 类 号：R943[医药卫生—药剂学]