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Fingerprint establishment method and quality evaluation method of Zhinao capsule

A technique for fingerprinting and establishing methods, which is applied in the field of establishing fingerprints and quality evaluations of Zhinao Capsules, can solve problems such as inability to fully control and respond to preparation quality, single means, etc., and achieve good sample stability, good separation effect, and instrumentation good precision effect

Active Publication Date: 2021-11-30
FIRST AFFILIATED HOSPITAL OF ANHUI UNIV OF CHINESE MEDICINE
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  • Claims
  • Application Information

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Problems solved by technology

However, the current method of quality control is relatively single, and cannot fully control and reflect the quality of the preparation.

Method used

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  • Fingerprint establishment method and quality evaluation method of Zhinao capsule
  • Fingerprint establishment method and quality evaluation method of Zhinao capsule
  • Fingerprint establishment method and quality evaluation method of Zhinao capsule

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Embodiment 1

[0025] The invention provides a method for establishing fingerprints of Zhinao capsules and a quality evaluation method, the specific steps are as follows:

[0026] (1) Production of Zhinao Capsules:

[0027] The prescription of Zhinao Capsules consists of Codonopsis 15g, Astragalus 15g, Polygonatum 12g, Cistanche 15g, Curcuma 10g, Shichangpu 8g, Chuanxiong 10g, Dilong 8g. Weigh 1000 times the amount of prescription medicinal materials, reflux with 10 times the amount of 75% ethanol for 1 hour, and filter out the reflux liquid; then add 8 times the amount of 75% ethanol to reflux for extraction for 40 minutes, and filter out the reflux liquid; combine the two reflux liquids, and recover Ethanol, concentrated medicinal solution, dried, added with excipient dextrin, wet granulated, packed in size 0 capsules, 0.4g per capsule, 50 capsules per bottle, packaged.

[0028] (2) Preparation of the test solution:

[0029] According to the above method, 10 batches of Zhinao capsules we...

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Abstract

The invention relates to a fingerprint establishment method and a quality evaluation method of the Zhinao capsule, and belongs to the technical field of compound traditional Chinese medicine preparation quality control management. A proper amount of Zhinao capsule content is taken, methanol is added for ultrasonic extraction, and a filter membrane is used for filtration; a reference substance is weighed precisely and adding methanol to prepare a reference substance solution with a certain concentration; acetonitrile-water is selected as a mobile phase, and gradient elution is adopted; DAD is selected as a detector, and BEH C18 is selected as a chromatographic column; 10 batches of sample UPLC maps are obtained through measurement, the obtained UPLC maps are imported into similarity evaluation software, the sample similarity is calculated, and a standard fingerprint map is determined; if the similarity is greater than 0.90, the quality requirement of the Zhinao capsule is met, so that the quality evaluation of the to-be-tested Zhinao capsule sample is completed. According to the invention, the fingerprint spectrum of the Zhinao capsule is constructed by using the ultra-high performance liquid chromatography, the standard fingerprint spectrum of the Zhinao capsule is determined by analyzing multiple batches of the Zhinao capsules, and a stable and reliable quality control method of the Zhinao capsule is established.

Description

technical field [0001] The invention belongs to the technical field of product control and management of compound traditional Chinese medicine preparations, and in particular relates to a method for establishing fingerprints of Zhinao capsules and a quality evaluation method. Background technique [0002] At present, traditional Chinese medicine fingerprint technology mainly includes thin-layer scanning (TLCS), high-performance liquid chromatography (HPLC), gas chromatography (GC) and high-performance capillary electrophoresis (HPCE) and other chromatography methods, as well as ultraviolet spectroscopy (UV), Spectroscopic methods such as infrared spectroscopy (IR), mass spectrometry (MS), nuclear magnetic resonance (NMR) and X-ray diffraction. Among them, chromatographic methods are the mainstream methods, especially HPLC, TLCS and GC have become three recognized routine analysis methods. Because high-performance liquid chromatography (HPLC) has the characteristics of high ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86G01N30/88
CPCG01N30/8686G01N30/88G01N2030/8809
Inventor 杨文明汪永忠郝文杰韩燕全陈燕
Owner FIRST AFFILIATED HOSPITAL OF ANHUI UNIV OF CHINESE MEDICINE
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