灵益胶囊用于健康人的耐受性观察

The Study of Suffertibility of Ningyi Capsule for Volunteer

为了考察灵益胶囊在健康人体的耐受性，采用与安慰剂的随机双盲对照研究，征集３６名健康自愿受试者，随机分为６组，接受灵益胶囊和安慰剂的单剂量空腹顿服，结果发现灵益胶囊的安全单剂量范围为１６～６４克（４～１６粒），主要不良反应为口干、恶心呕吐、头晕、全身无力、食欲不振和思睡、腹泻，大部分为轻度不良反应，少部分为中度反应，无需处理自行消失。试验中未出现严重不良反应。对服药前后体温、心率、血压等生命体征，血、小便常规，肝肾功能及心电图进行了监测，发现各剂量组与安慰剂组类似，均在正常范围内波动，说明灵益胶囊对健康个体耐受性较高，短期用药对人体正常生理代谢无明显影响。

In order to study the suffertibility and safety of Ningyi capsule,single dosage of Ningyi capsule or placebo was administrated to 36 cases of healthy volunteers,who were randomly divided into 6 groups.The result showed that the range of safe single dosage was from 1 6 grams to 6 4 grams,with mild to medium side effect such as dry mouth,nausea,vomiting,dizziness, adynamia ,inappetence,sleepiness,diarrhea,all of these need no treatment and alleviated spontaneously.There found no change of temperature,pulse,blood pressure and routine chemical examinations after take capsules.The results indicated that Ningyi capsule possessed of highly suffertibility and safety.