Researches On The Production And Evaluation Of The Placebo Of Chinese Herbal Granules

With the development of evidence-based medicine, the placebo get more attention. Evaluation of the placebo is a common problem in the pharmaceutical industry, this paper explores the quality evaluation and preparation methods of the placebo of traditional Chinese medicine granules, and finds some law to achieve the objective evaluation of the placebo and lay the foundation for third-party evaluation.According to the particularity of Chinese medicines, we take a small amount of the original preparation and some accessories to make placebo of traditional Chinese medicine. The traits of the placebo is highly similar to the original preparation, and the placebo has no physiologically active. We take TCSH and HXZQ particles as model, with intelligent sensory technology as evaluation methods, study preparation process and quality evaluation method of the traditional Chinese medicine placebo.In preparation technology, referring to the traits of the original medicine, we take10%(w/w) the original drugs and some other materials such as diluent agent, color agent, taste agent, by mixing, drying, crushing, screening, granulation, the placebo is made, diluent agent include lactose, flour, sugar; agent of color is edible caramel pigment, food grain, edible citric yellow sunset yellow pigment,10%of beta carrots pigment and GuoLu edible pigment; Taste masking agent is bitter agent and aspartame. the placebo of traditional Chinese medicine granule made under the preparation process is highly similar to the original drug. In the verifying test, refer to the quality standards of original drug and placebo, TLC, the content determination of HPLC was studyed, verify the placebo of traditional Chinese medicine granule made under the preparation contain and only contains10%(w/w) of original drug, the result is good.In the quality evaluation of placebo, this paper determined the shape color and smell of original drugs and placebo with intelligent sensory technology (machine vision, electronic noses, electronic tongue), in which the shape and the colo by machine vision, smell by the electronic nose, taste by the electronic tongue and the results are calculated, and then took the similarity on comprehensive scores, and reach the objective evaluation of placebo of traditional Chinese medicine. The results show that,the placebo of TCSH and HXZQ particles under the preparation are qualified products. In the pharmacological experiments, according to the functions of the drug, two models were built, The results show that, the placebo under the preparation don’t have physiological activity, the result is good.This paper established a preparation methods and evaluation technology (intelligence, efficacy) on placebo of Chinese medicine granule and apply for the related intellectual property rights protection.