摘要
目的探讨医院制剂栀防止痒颗粒临床疗效与质量标准的研究情况。方法选取2015年1月至2018年1月在本院就诊的风热型慢性荨麻疹患者124例作为研究对象,根据治疗方式的不同分为观察组(n=61)和对照组(n=63)。对照组采用常规西药肤痒颗粒进行治疗,观察组采用栀防止痒颗粒进行治疗。调查两组患者的临床效果以及建立科学的检验方法,判断栀防止痒颗粒的质量标准。结果观察组痊愈例数为42例,占比66.7%,对照组痊愈例数为40例,占比63.5%,两组患者痊愈率差异无统计学意义,可见栀防止痒颗粒与常规西药相比,具有相当的疗效;两组患者不良反应情况比较,差异无统计学意义,表明栀防止痒颗粒并不会增加患者不良反应发生率;分别对10批供试品中栀子苷的含量进行测定,根据10批供试品含量测定结果,暂定本品每袋含栀子以栀子苷(C17H24O10)计,不得少于8.0 mg。结论栀防止痒颗粒疗效确切,效果明显,且服用安全无明显毒副作用,且本院制备工艺能够较好的保存放中的有效成分,最大限度发挥药物的功效。
Objective:To discuss the study condition of clinical efficacy and quality standard of Zhi Fang Zhi Yang Granule of hospital preparation.Methods:124 patients with chronic urticaria of wind-heat type who were treated in our hospital from January 2015 to January 2018 were selected as the study object,which was divided into observation group(n=61)and control group(n=63)according to the different treatment methods.The control group was treated with routine western medicine Fuyang granule,and the observation group was treated with Zhi Fang Zhi Yang Granule.The clinical effect of the two groups of patients was investigated and a scientific test method to judge the quality standard of Zhi Fang Zhi Yang Granule was established.Results:42 cases were cured in the observation group(66.7%)and 40 cases in the control group(63.5%).There was no significant difference in the recovery rate between the two groups(P>0.05).It showed that Zhi Fang Zhi Yang Granule had considerable curative effect compared with conventional Western medicine.The adverse reactions of two groups of patients was compared,the results showed that there was no significant difference between the two groups(P>0.05).The results showed that gardenoside did not increase the incidence of adverse reactions.The content of gardenoside in 10 batches of samples was determined.According to the determination results of 10 batches of samples,it was tentatively determined that gardenoside(C17H24O10)should not be less than 8.0mg in each bag of gardenoside.Conclusion:Zhi Fang Zhi Yang Granule is definite and obvious,and it is safe to take without obvious toxic and side effects.The preparation process of Zhi Fang Zhi Yang Granule in our hospital is feasible.It can better preserve the active ingredients in the storage and maximize the efficacy of the drug.
作者
徐德钢
相勇
陈体高
温琰
李佳娟
Xu Degang;Xiangyong;Chen Tigao;Wen Yan;Li Jiajuan(Department of Pharmacy,Ganzhou City Dermatology Hospital,Ganzhou,Jiangxi,341000,China;Dermatological Department of Pharmacy,Ganzhou City Dermatology Hospital,Ganzhou,Jiangxi,341000,China;TCM Dermatology of Pharmacy,Ganzhou City Dermatology Hospital,Ganzhou,Jiangxi,341000,China;Medical department of Ganzhou Food and Drug Inspection and Testing Center,Ganzhou,Jiangxi,341000,China)
出处
《当代医学》
2019年第36期13-15,共3页
Contemporary Medicine
基金
江西省卫生计生委中医药科研课题(2016A149)
关键词
医院制剂
栀防止痒颗粒
疗效
质量标准
Hospital preparations
Zhi Fang Zhi Yang Granule
Therapeutic effect
Quality standard
