Traditional Chinese medicine placebo, as well as preparation process and evaluation method thereof

A technology of placebo and traditional Chinese medicine, applied in the field of traditional Chinese medicine placebo, preparation process and evaluation, can solve the problems of large interference of subjective and objective factors, affecting the accuracy and stability of results, achieve objective quantification of trait evaluation, avoid subjective bias, Similar effects

Inactive Publication Date: 2013-05-22
CHENGDU UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method is greatly disturbed by subjective and objective factors. Factors such as the external environment, the physical condition of the evaluator, and the mental state often affect the accuracy and stability of the results.

Method used

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  • Traditional Chinese medicine placebo, as well as preparation process and evaluation method thereof
  • Traditional Chinese medicine placebo, as well as preparation process and evaluation method thereof
  • Traditional Chinese medicine placebo, as well as preparation process and evaluation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The evaluation method of embodiment 1 Chinese medicine placebo

[0048] (1) Take the traditional Chinese medicine placebo and the therapeutic drug preparation, measure the visual indicators, taste indicators, and olfactory indicators of the two through visual sensors (machine vision), taste sensors (electronic tongue), and olfactory sensors (electronic nose), and calculate them respectively its similarity;

[0049] (2) Comprehensively score the indicators obtained in step (1), and if the scoring standard is greater than 80%, it is a qualified traditional Chinese medicine placebo.

[0050] Machine vision enables objective quantification of color, electronic nose enables objective quantification of odor, and electronic tongue enables objective quantification of taste. The comprehensive score of the three can improve accuracy. Wherein, when the therapeutic drug preparation described in step (1) is an oral preparation, the weight coefficients for comprehensive scoring in s...

Embodiment 2

[0053] The placebo preparation method of the Chinese medicine preparation that embodiment 2 liquid form takes

[0054] When the therapeutic drug preparation is finally taken in liquid form, the preparation method of its placebo comprises the following steps:

[0055] (1) Take the therapeutic drug preparation, dissolve or dilute it with water or ethanol, and obtain the dilution of the original preparation for use, and observe the color of the dilution;

[0056] (2) Take the therapeutic drug preparation again, whose weight or volume is 0-20% of the therapeutic drug preparation in step (1), add the same volume of water or ethanol in step (1), and then add excipients / solvents, color correctors and correctives to obtain a placebo dilution. At the same time, with reference to the shape, color, smell, and taste of the original preparation dilution, adjust the addition of excipients, color correctors, and correctives. When the shape, color, smell, and taste of the preparation dilutio...

Embodiment 3

[0058] Embodiment 3 solid form takes the placebo preparation method of traditional Chinese medicine preparation

[0059] When the therapeutic drug preparation is finally taken in solid form, the preparation method of its placebo comprises the following steps:

[0060] (1) Accurately weigh the therapeutic drug preparation, the weight of which is 3-15% w / w of the original unit therapeutic drug preparation, pulverize and set aside;

[0061] (2) According to the original preparation process of the therapeutic drug preparation, take the same type and the same amount of excipients, mix them with the weighed material in step (1), and then select and adjust the excipients according to the shape, color, gas and taste of the therapeutic drug preparation powder When the type and amount of the corrective agent, color corrector, and corrective agent are the same or similar to the original preparation, the therapeutic drug preparation, excipient, color corrective agent, and corrective agent...

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Abstract

The invention provides a traditional Chinese medicine placebo preparation process. The invention also provides a traditional Chinese medicine placebo and an evaluation method of the placebo. According to the invention, a small amount of an original preparation (granule, mixture, tablet, capsule, pill, external preparation, and the like) is taken and prepared into a traditional Chinese medicine placebo, the similarity of properties of the placebo and the original preparation is high, and the placebo has no physiological activity, therefore, the placebo is more suitable for clinical and experimental research; meanwhile, the invention also provides a multi-sensing information fusion based intelligent sensory evaluation method for the traditional Chinese medicine placebo, which is implemented through simulating three sensory organs, namely, eye, nose and tongue of the human body respectively by using a machine vision (visual sensor), an electronic nose (smell sensor) and an electronic tongue (taste sensor), so that the objective quantification of properties evaluation of the traditional Chinese medicine placebo is realized, and the subjective deviation caused by the experiential sensory evaluation of people is avoided.

Description

technical field [0001] The invention relates to a traditional Chinese medicine placebo, a preparation process and an evaluation method. Background technique [0002] In 1970, the U.S. Food and Drug Administration (FDA) approved placebo-controlled studies when evaluating the efficacy of new drugs. With the rise of evidence-based medicine, the use of placebo-controlled clinical trials in TCM clinical research has grown rapidly over the past two decades. Placebo refers to a preparation that is composed of a neutral substance that has neither drug effect nor adverse reaction, and is similar in appearance to the original preparation. Traditional Chinese medicine (Chinese patent medicine) usually consists of a few to a dozen ingredients, with complex active ingredients and unique appearance, taste and smell of traditional Chinese medicine. Currently, placebos are mostly prepared from excipients, and it is difficult to meet the requirements of traditional Chinese medicine. Unique...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/00G01N33/15
Inventor 吴纯洁何祖新王忠张磊刘克成
Owner CHENGDU UNIV OF TRADITIONAL CHINESE MEDICINE
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