ABSTRACT
ObjectiveTo evaluate the efficacy of Zishui Bugan decoction on perimenopausal insomnia of liver-kidney deficiency type and the safety. MethodA randomized， double-blind， placebo-controlled trial was designed. To be specific， 72 patients of perimenopausal insomnia with Liver-kidney deficiency were randomized into the treatment group and the control group at the ratio of 1∶1 and they were respectively treated with Zishui Bugan decoction and placebo for 3 weeks. The Pittsburgh sleep quality index （PSQI）， modified Kupperman index， traditional Chinese medicine （TCM） syndrome score， self-rating anxiety scale （SAS） score， and self-rating depression scale （SDS） score， were compared before and after treatment to determine the clinical efficacy， with adverse effects recorded. ResultThe total effective rate for insomnia was 85.3%（29/34） in treatment group and 17.6%（6/34） in control group（Z=-5.582，P<0.01）. After treatment， PSQI score， modified Kupperman index， TCM syndrome score， and SAS score were improved in both groups （P<0.05， P<0.01）， particularly the treatment group which showed significant difference from the control group （P<0.05，P<0.01）. The safety indicators were insignificantly different between two groups before and after treatment. No related adverse effects were reported in both groups during the treatment. ConclusionZishui Bugan decoction can improve the sleep quality and alleviate the menopausal symptoms， such as depression and anxiety， which shows ideal efficacy and safety for the perimenopausal insomnia with liver-kidney deficiency type.
ABSTRACT
OBJECTIVE:To optimize the formulation of dextromethorphan hydrobromide sustained-release tablets. METHODS: The dextromethorphan hydrobromide sustained-release tablets were prepared with HPMC as sustained release matrix. Orthogonal test was performed to optimize the formulation with in vitro accumulative drug release rate as index and the amount of HPMC and lactose as well as ethylcellulose (EC) concentration as factors. Then verification test on the in vitro drug release characteristics of the optimized tablets were performed and the influencing factors (high temperature,high light,and high moisture) were investigated as well. RESULTS: The optimized formulation of dextromethorphan hydrobromide sustained-release tablets was as follows: 30 mg HPMC,50 mg lactose,and 8% EC. The accumulative drug release rate at 8 h was above 70%. In the influencing factor test,the tablets were stable under all conditions except at high moisture condition. CONCLUSION: The optimized formulation of dextromethorphan hydrobromide sustained-release tablets is feasible.
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OBJECTIVE:To prepare Yinxingye extract pellets and study its in vitro drug release rate.METHODS:The Yinxingye extract were coated with 3 coating materials(opadryⅡ,Eudragit L30D-55 and Eudragit S 100,respectively)to be prepared into pallets by centrifugalized palletizing method;and the 3 different coated pallets were prepared into mixed pallets in an pre-designed ratio.The in vitro release of the 3 coated pallets and the mixed-coated pallets were determined by changing the pH-gradient of media(0.1 mol?L-1 hydrochloric acid,pH 5.8 PBS,pH 7.2 PBS).RESULTS:The pallets coated with 3 different coating materials released quickly in 0.1 mol?L-1 hydrochloric acid,pH 5.8 PBS and pH 7.2 PBS,and the pellets with mixed coating materials had a sustained release until a complete release within about 8 h in pH gradient-changed media.CONCLUSION:The preparation process is feasible and provides theoretic basis for industrial production.
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OBJECTIVE:To optimize the preparation technology of roxithromycin microspheres.METHODS:The microspheres of roxithromycin were prepared by the emulsion-solvent diffusion method with ethylcellulose used as capsule wall material.The preparation technology of microspheres was optimized by orthogonal experiment taking encapsulation efficiency as index with the ratio of roxithromycin to ethylcellulose(A),the concentration of ethylcellulose(B)and the ratio of water phase to oil phase(C)as factors.The appearance,particle diameter,drug-loading amount,encapsulation efficiency,in vitro release and bitter smell were studied.RESULTS:The optimal preparation conditions were as follows:A was 1∶1,B was 30 ?g?mL-1 and C was 4∶1.The microspheres obtained were round and well-distributed with mean diameter of 75.0～90.0 ?m,drug-loading amount of 45%～46%,encapsulation efficiency of over 90% and sustained release for over 13 hours.No bitter taste of the roxithromycin-ethylcellulose microspheres was felt by the majority of subjects.CONCLUSION:The roxithromycin microspheres made by optimization technology was bitter-masked and sustained release.