Fushengkang preparation, preparation method and quality control method thereof

A quality inspection method and Fushengkang technology, which can be used in measuring devices, pharmaceutical formulations, medical preparations containing active ingredients, etc., and can solve problems such as lack of rigor

Inactive Publication Date: 2009-02-04
阙锋
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the process of production practice, the original manufacturer found that the method is still not very rigorous, and needs to be further modified an

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] A Fushengkang preparation, the raw materials of which contain sunflower seed, octopus fruit, curcuma, bupleurum, gynostemma, shiitake mushroom, astragalus, and licorice, the weight-to-number ratio of which is 300:275:125:125:125:90:125:40 ; Every 0.38 gram of Fushengkang preparation contains camptothecin C 20 h 16 N 2 o 4 In total, it is 0.09-0.20 mg; the detection methods adopted in the quality detection items of the Fushengkang preparation are: identification control detection of palmflower seed extract, identification control detection of camptothecin, identification control detection of zedoary extract, astragaloside IV The method of differential contrast detection is thin-layer chromatography, the method of camptothecin content contrast detection is high performance liquid chromatography, and the method of content morphology observation and detection is microscope inspection; the process of each described detection is:

[0069] The detection process is as follow...

Embodiment 2

[0131] This embodiment is a preferred solution based on Embodiment 1. In this embodiment, during the preparation of the test solution of the Fushengkang preparation used for the various detections described above, the consumption of the Fushengkang preparation was further optimized;

[0132] When preparing the described Pukuizi extract reference solution and Curcuma extract reference solution for detection, the sampling volume of Pukuizi reference medicinal material and Zedoary reference medicinal material is further optimized;

[0133] In each of the detections, the component distribution ratio of the various developing agents is further optimized;

[0134] The operation method of the present embodiment is identical with embodiment 1;

[0135] I. Palm sunflower extract identification control test:

[0136] A. Fushengkang preparation test solution preparation:

[0137] The weight ratio of the Fushengkang preparation and methanol is 1:2; the consumption of the Fushengkang pr...

Embodiment 3

[0180] This embodiment is a preferred solution based on Embodiment 1. In this embodiment, during the preparation of the test solution of the Fushengkang preparation used for the various detections described above, the consumption of the Fushengkang preparation was further optimized;

[0181] When preparing the described Pukuizi extract reference solution and Curcuma extract reference solution for detection, the sampling volume of Pukuizi reference medicinal material and Zedoary reference medicinal material is further optimized;

[0182] In each of the detections, the component distribution ratio of the various developing agents is further optimized;

[0183] The operation method of the present embodiment is identical with embodiment 1;

[0184] I. Palm sunflower extract identification control test:

[0185] A. Fushengkang preparation test solution preparation:

[0186] The weight ratio of the Fushengkang preparation to methanol is 0.3:2; the consumption of the Fushengkang p...

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PUM

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Abstract

The invention provides a resurging preparation, a preparation method and a quality detection method thereof; the raw material of the preparation includes Chinese fanpalm seed, common camptotheca fruit, rhizoma zedoariae, radix bupleuri, fiveleaf gynostemma herb, champignon, radix astragali and liquorice; the preparation method includes the steps that the radix astragali is ground into powder, the rhizoma zedoariae is extracted to obtain naphtha and aqueous solution, other raw materials are treated and added with the aqueous solution of rhizoma zedoariae and radix astragali fine powder to obtain dry ointment which is evenly mixed with the naphtha to be packed into capsule, thus obtaining the finished products. The test items are that extract of the Chinese fanpalm seed is distinguished and carried out contrast detection, camptothecin is distinguished and carried out contrast detection, extract of the rhizoma zedoariae is distinguished and carried out contrast detection, astragaloside IV is distinguished and carried out contrast detection, the content of camptothecin is carried out contrast detection, and the form of internal content is observed and tested; every 0.38g of resurging preparation contains 0.09-0.20mg of camptothecin C20H16N2O4; the preparation method determines crucial technological parameter again, and can guarantee safety, effectivity and uniformity of quality of the medicine; the detection method combines determination on the nature and definite quantity, is precise and has reliable data.

Description

technical field [0001] The invention relates to the field of compound pharmaceutical preparations and analysis thereof, in particular to a Fushengkang preparation, a preparation method and a quality detection method thereof. technical background [0002] Chinese patent application 200410012693.2 (publication number CN1557380A) discloses a preparation process of an anticancer traditional Chinese medicine oral preparation. The oral preparation has the effects of promoting blood circulation and removing blood stasis, invigorating the spleen and eliminating stagnation; being used for gastric cancer and liver cancer, it can enhance the curative effect of radiotherapy and chemotherapy, and can enhance the immune function of the body; and can improve the clinical symptoms of patients with liver cancer. The product name of the patented product is Fushengkang, which is a pure traditional Chinese medicine anti-cancer drug exclusively produced in the country. Therefore, special prepar...

Claims

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Application Information

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IPC IPC(8): A61K36/906A61P35/00G01N30/36G01N30/90
Inventor 阙锋
Owner 阙锋
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