中药防脱纳米混悬剂的制备及其质量控制研究

The preparation of traditional Chinese medicine anti-hair loss-nanosuspension and its quality control research

目的以二苯乙烯苷为原料制备一种中药防脱纳米混悬剂,采用单因素试验及正交试验优化其处方工艺,并对其进行质量控制研究。方法通过微型化介质研磨设备完成中药防脱纳米混悬剂的制备,采用单因素试验法对中药防脱纳米混悬剂的稳定剂种类和用量进行优选[20],再采用正交试验法对研磨条件进行再次优选,得到最优处方,并考察其外观形态、药物溶解度、粒径分布及稳定性。结果最优处方:以10mL西林瓶作为研磨室,二苯乙烯苷原料药15mg,十二烷基硫酸钠5mg,水5ml,氧化锆珠体积1.1mL,研磨转速1300r·min^(-1),研磨时间3.5h。以最优处方制备的三批中药防脱纳米混悬剂平均粒径为(275.4±18.8)nm,理化性质稳定,药物溶解度较高。结论该制备工艺简单可行。

Objective To prepare a traditional Chinese medicine anti-hair loss-nanosuspensions with tetrahydroxystilbene-glucoside as raw material,to explore and optimize its prescription process by single-factor experiment and orthogonal experiment,and to characterize its morphological crystals,and to investigate its drug content and formulation stability.Methods Using 10 mL penicillin bottle as the grinding chamber,using magnetic mixing device as the power source,using Zirconia beads as grinding medium to build miniaturized media grinding equipment.The single-factor test method is used to select the type and amount of stabilizer of tetrahydroxystilbene-glucoside nanosuspensions,and then the orthogonal test method is used to select the grinding time,grinding speed and grinding medium volume,and get the best preparation prescription.The results showed that the optimal process parameters were used:10 mL penicillin bottle as container,tetrahydroxystilbene-glucoside raw material 15 mg,sodium dodecyl sulfate 5 mg,distilled water 5 mL,grinding medium volume 1.1 mL,grinding speed 1300 r/min,grinding time 3.5 h.Results The three tetrahydroxystilbene-glucoside nanosuspensions average particle size prepared with optimal prescriptions and processes were 275.4±18.8 nm.During the stability study,the average particle size fluctuation was less than 30 nm,indicating that the prescription and preparation process was stable and feasible.Conclusion The preparation process is simple and feasible.