A method for establishing fingerprints of Zhinao capsules and a method for quality evaluation

A technology of fingerprint spectrum and establishment method, applied in the field of Zhinao Capsule fingerprint establishment method and quality evaluation, can solve the problems of inability to comprehensively control and react the quality of preparations, single means, etc., and achieve good sample stability, good separation effect, exclusive strong effect

Active Publication Date: 2022-02-11
FIRST AFFILIATED HOSPITAL OF ANHUI UNIV OF CHINESE MEDICINE
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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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  • A method for establishing fingerprints of Zhinao capsules and a method for quality evaluation
  • A method for establishing fingerprints of Zhinao capsules and a method for quality evaluation
  • A method for establishing fingerprints of Zhinao capsules and a method for quality evaluation

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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

A method for establishing fingerprints of Zhinao capsules and a quality evaluation method, belonging to the technical field of product control and management of compound traditional Chinese medicine preparations, taking an appropriate amount of the contents of Zhinao capsules, adding methanol for ultrasonic extraction, and filtering through a filter membrane; accurately weighing a reference substance and adding methanol to prepare the product. A certain concentration of reference substance solution; choose acetonitrile-water as the mobile phase, and use gradient elution; choose DAD as the detector, and choose BEH C as the chromatographic column 18 ; Measure and obtain UPLC spectra of 10 batches of samples, import the obtained UPLC spectra into the similarity evaluation software, calculate the similarity of the samples, and determine the standard fingerprints; if the similarity is greater than 0.90, it meets the quality requirements of Zhinao Capsules, so as to complete the intelligence to be tested Quality assessment of brain capsule samples. The invention utilizes ultra-high performance liquid chromatography to construct the fingerprints of Zhinao capsules, analyzes multiple batches of Zhinao capsules to determine their standard fingerprints, and establishes a stable and reliable quality control method for Zhinao capsules.

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 Patents(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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