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Chinese medicinal preparation placebo for treating gonarthromeningitis and preparation method thereof

A technique of traditional Chinese medicine preparation and synovitis, which is applied in the field of placebo for clinical trials of drugs, and can solve problems such as incomplete compliance with placebo

Inactive Publication Date: 2012-08-15
HENAN LUOZHENG PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention patent with the application number of 201110075366.1 discloses a placebo of coronary heart disease prescription, but it contains medicinal ingredients of coronary heart disease prescription free decoction granule, which does not fully meet the requirements of placebo

Method used

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  • Chinese medicinal preparation placebo for treating gonarthromeningitis and preparation method thereof
  • Chinese medicinal preparation placebo for treating gonarthromeningitis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The placebo of the traditional Chinese medicine preparation for the treatment of knee joint synovitis described in this embodiment is made from the following raw materials in parts by weight: 80 parts of maltodextrin, 8 parts of caramel pigment, 0.04 part of sucrose octaacetate, aspartame 0.10 parts, 0.40 parts of mint essence, and 0.20 parts of milk essence.

[0028] The above-mentioned each component is made the preparation method of the placebo of Chinese medicine preparation placebo for the treatment of knee joint synovitis described in the present invention: take maltodextrin, caramel pigment, sucrose octaacetate, aspartame according to the above-mentioned formula ratio, Add 3 times the amount of water to dissolve, mix evenly, and spray dry the mixture; add mint essence and milk essence to the spray-dried powder, mix evenly, dry granulate, granulate with 12 mesh and 60 mesh sieve, and pack.

Embodiment 2

[0030] The placebo of the traditional Chinese medicine preparation for treating knee joint synovitis described in this embodiment is made of the following raw materials in parts by weight: 100 parts of maltodextrin, 10 parts of caramel pigment, 0.05 part of sucrose octaacetate, and aspartame 0.21 parts, 0.52 parts of mint flavor, 0.31 parts of milk flavor.

[0031] The above-mentioned each component is made the preparation method of the placebo of Chinese medicine preparation placebo for the treatment of knee joint synovitis described in the present invention: take maltodextrin, caramel pigment, sucrose octaacetate, aspartame according to the above-mentioned formula ratio, Add 3 times the amount of water to dissolve, mix evenly, and spray dry the mixture; add mint essence and milk essence to the spray-dried powder, mix evenly, dry granulate, granulate with 12 mesh and 60 mesh sieve, and pack.

Embodiment 3

[0033] The placebo of the traditional Chinese medicine preparation for treating knee joint synovitis described in this embodiment is made of the following raw materials in parts by weight: 120 parts of maltodextrin, 12 parts of caramel pigment, 0.06 part of sucrose octaacetate, and aspartame 0.30 parts, 0.60 parts of mint flavor, 0.40 parts of milk flavor.

[0034] The above-mentioned each component is made the preparation method of the placebo of Chinese medicine preparation placebo for the treatment of knee joint synovitis described in the present invention: take maltodextrin, caramel pigment, sucrose octaacetate, aspartame according to the above-mentioned formula ratio, Add 3 times the amount of water to dissolve, mix evenly, and spray dry the mixture; add mint essence and milk essence to the spray-dried powder, mix evenly, dry granulate, granulate with 12 mesh and 60 mesh sieve, and pack.

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Abstract

The invention discloses a Chinese medicinal preparation placebo for treating gonarthromeningitis and a preparation method thereof. The placebo is prepared from the following raw materials in parts by weight: 80 to 120 parts of maltodextrin, 8 to 12 parts of caramel pigment, 0.04 to 0.06 part of sucrose octaacetate, 0.10 to 0.30 part of aspartame, 0.40 to 0.60 part of peppermint essence, and 0.20 to 0.40 part of milk essence. The preparation method comprises the following steps: dissolving the maltodextrin, the caramel pigment, the sucrose octaacetate and the aspartame with water, uniformly mixing, and performing sprayed-drying to the mixed solution; and adding the peppermint essence and the milk essence into the sprayed-dry powder, uniformly mixing, pelletizing by a dry method, granulating, and packaging. The placebo has similar appearance, taste and the like as those of a medicament for treating gonarthromeningitis, cannot be easily identified by a researcher and a tested person, and can furthest prevent double-blind, bias and unblinding occurring in the clinical test of placebo contrast, so that the quality of clinical tests is ensured.

Description

technical field [0001] The invention belongs to the technical field of placebos for drug clinical trials, and mainly relates to a placebo of a traditional Chinese medicine preparation for treating knee joint synovitis and a preparation method thereof. Background technique [0002] A scientific drug clinical trial should implement the four basic principles of randomization, control, blinding and repetition. Placebos are often used for comparison and blinding purposes. [0003] A placebo is a "dummy" drug that has physical characteristics such as appearance, size, color, dosage form, weight, taste and smell as closely as possible to the test drug, but does not contain the active ingredient of the test drug. The purpose of setting placebo is to overcome the bias formed by psychological factors such as researchers, subjects, and staff involved in the evaluation of efficacy and safety, to eliminate the influence of natural progression of the disease, and to reflect the "absolute...

Claims

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Application Information

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IPC IPC(8): A61K49/00
Inventor 赵新杰夏华玲刘培建武爱玲江海肖李四中
Owner HENAN LUOZHENG PHARMA FACTORY
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