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Daochi powder formula granule as well as preparation method, use and detection method thereof

A technology of formula granules and Daochi powder, applied in the field of Daochi powder formula granules and their preparation, can solve the problems of changes in pharmacological action, non-equivalence, changes in clinical efficacy, etc.

Active Publication Date: 2013-11-27
KANGMEI PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mixing and dissolving of single Chinese medicine formula granules will not have all the active ingredients of "group medicine co-decoction", or the formula granules prepared according to the existing technology will not completely contain the active ingredients required by traditional Chinese medicine, resulting in changes in the material basis of traditional prescriptions , so that the existing formula granules cannot be equivalent to the traditional Chinese medicine decoction
May eventually lead to changes in clinical efficacy or changes in pharmacological effects

Method used

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  • Daochi powder formula granule as well as preparation method, use and detection method thereof
  • Daochi powder formula granule as well as preparation method, use and detection method thereof
  • Daochi powder formula granule as well as preparation method, use and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Example 1 Selection of preparation process of Daochisan formula granules

[0089] Preparation:

[0090] Take the raw rehmannia, wood tongs, bamboo leaves and raw licorice with a mass ratio of 1:1:1:1, soak in water, decoct, filter, combine the filtrate and concentrate it into a clear paste, then dry and granulate.

[0091] 1. The research on the extraction technology of Daochisan formula granules is as follows:

[0092] The influencing factors are: extraction times, extraction time, water addition (unit is L / Kg total amount of medicinal materials). Optimizing the extraction process by orthogonal test, choose L 9 (3 4 ) Orthogonal table, focusing on the above three factors, taking the content of glycyrrhizic acid as the inspection index, and the factor level table is shown in Table 2.

[0093] Table 2

[0094]

[0095] Test method: Weigh 100g of raw rehmannia, 100g of raw licorice, 100g of mutong, and 100g of bamboo leaves according to the prescription ratio, number 1-9, press L ...

Embodiment 2

[0106] Example 2 Preparation of Daochisan formula granules

[0107] Take 180.1g of Rehmannia glutinosa, 180.0g of Mutong, 180.0g of bamboo leaves, and 180.2g of licorice, soak in water for 30 minutes, decoct twice, add 10 times the amount of water for the first time, add 8 times the amount of water for the second time, each time Boil for 1.0 hour, filter, combine the two filtrates, concentrate under reduced pressure at 80°C, concentrate to a clear paste with a relative density of 1.05~1.10 (60°C), microwave drying, microwave power 5Kw, material temperature 65°C, drying time: 25min, dry to obtain the extract powder, which is granulated, packed, sieved and tested to obtain the finished product. See the process flow chart figure 1 .

[0108] The dry extract powder results are shown in Table 6.

[0109] Table 6 Extraction result table

[0110]

[0111] Obtained 192.8g of Daochisan formula granule powder.

[0112] See Table 7 for the particle properties of Daochisan formula.

[0113] Tabl...

Embodiment 3

[0116] Example 3 Identification of Daochishan formula granules prepared in Example 2 by thin layer chromatography

[0117] 1. Medicinal materials and reagents

[0118] Licorice reference medicinal material: batch number 120934-200608, purchased from the National Institute for the Control of Pharmaceutical and Biological Products;

[0119] Test product: Daochi powder formula granules (prepared according to the method in Example 2, batch numbers: 12060401, 12060402, 12060403), made by Kangmei Pharmaceutical Co., Ltd.;

[0120] Licorice negative control: take 180.1g of Rehmannia glutinosa, 180.0g of Mutong, and 180.0g of bamboo leaves, which were prepared according to the method of Example 2;

[0121] Thin layer plate: Silicone G plate (made by Kangmei Pharmaceutical Co., Ltd.).

[0122] Reagents are of analytical grade

[0123] 2. Experimental steps

[0124] Identification of licorice in Daochisan formula granules

[0125] Preparation of test solution: Take 2.0g of Daochisan formula partic...

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Abstract

The invention provides a daochi powder formula granule. The daochi powder formula granule consists of co-decoction extracts of dried rehamnnia root, raw liquorice, caulis akebiae and bamboo leaves. The invention further provides a preparation method, a use and a detection method of the daochi powder formula granule. The daochi powder formula granule disclosed by the invention keeps all characteristics of the daochi powder, has active ingredients, nature and flavor, channel tropism, major functions and effect which are consistent with those of conventional daochi powder, and also has a plurality of advantages of less dosage, quick effect, complete components, accurate curative effect and the like, does not need decoction, can be directly taken, and is safe and sanitary and convenient to carry and store. The preparation method of the daochi powder formula granule is simple, low in cost and suitable for industrial production. The identification method adopted by the detection method of the daochi powder formula granule has strong specificity, high content measurement accuracy, good repeatability, and the detection method can be used for effectively controlling the quality of the product during a product production process, so that the clinical effect and the safety of the daochi powder formula granule are ensured.

Description

Technical field [0001] The invention belongs to the field of traditional Chinese medicine. Specifically, the present invention relates to a Daochisan formula granule and a preparation method thereof. The present invention also relates to the use of the Daochisan formula granule and a detection method. Background technique [0002] Dao Chi San was created by Qian Yi, a famous pediatrician in the Northern Song Dynasty. According to the records in the "Straight Jue of Pediatric Medicine and Syndrome", to treat children, "the heart is hot, depending on the temperature in the mouth, the temperature in the mouth, or sleeping on the face, and cleavage of the teeth, the heart is hot." It is composed of raw licorice and bamboo leaves. It has the effect of clearing heat and diluting water, and is widely used. Due to the small dosage, it is also relatively suitable for children to take. Its compatibility features are the compatibility of heat-clearing and yin-nourishing products. Rehmanni...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61K9/16G01N30/90G01N30/88A61P9/00A61P13/00A61P1/02A61P17/00A61P27/02A61P15/08A61P31/00
Inventor 许冬瑾马兴田向飞军汪涛孙亮
Owner KANGMEI PHARMA
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