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

A technology of formula granules and detection methods, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, measuring devices, etc., and can solve problems such as inequalities, changes in clinical efficacy, and changes in pharmacological effects

Active Publication Date: 2015-05-20
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] The preparation process selection of embodiment 1 Daochi powder formula granules

[0089] Preparation:

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

[0091] 1. The research on the extraction process of Daochi powder formula granules is as follows:

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

[0093] Table 2

[0094]

[0095] Test method: Weigh 100g of raw rehmannia root, 100g of raw licorice, 100g of akebia, and 100g of bamboo...

Embodiment 2

[0106] The preparation of embodiment 2 Daochi powder formula granules

[0107] Take 180.1g rehmannia glutinosa, 180.0g akebia, 180.0g bamboo leaves, and 180.2g 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, and decoct 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 dry, the microwave power is 5Kw, the material temperature is 65°C, and the drying time is After 25 minutes, it was dried to obtain extract powder, and the finished product was obtained through granulation, sub-packaging, sieving, and testing. Process flow chart see figure 1 .

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

[0109] Table 6 Extract result table

[0110]

[0111] 192.8g of Daochisan formula granule powder was obtained.

[...

Embodiment 3

[0116] Example 3 TLC identification of Daochi powder formula granules prepared in Example 2

[0117] 1. Medicinal Materials and Reagents

[0118] Licorice control medicinal material: batch number 120934-200608, purchased from China 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 180.1 g of rehmannia glutinosa, 180.0 g of akebia, and 180.0 g of bamboo leaves, prepared according to the method in Example 2;

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

[0122] Reagents are analytically pure

[0123] 2. Experimental procedure

[0124] Identification of Licorice Root in Daochi San Formula Granules

[0125] Preparation of the test solution: Take 2.0 g of the above-mentioned Daochi p...

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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, and the present invention also relates to the use and detection method of the Daochisan formula granule. Background technique [0002] Daochi San was created by Qian Yi, a famous pediatric doctor in the Northern Song Dynasty. According to the records in the second volume of "Pediatric Medicine and Syndrome Straight Jue", treating children with "heart heat, depending on the sleep, the temperature in the mouth, or sleeping with the face closed, and clenching teeth, all have heart heat." , raw licorice, and bamboo leaves, it has the effect of clearing away heat and diuresis, and is widely used. Due to the small dose, it is also relatively suitable for children to take. Its compatibility is characterized by the compatibility of heat-clearing and yin-nourishing products. In the pre...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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