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Mass control method of Jichuan decoction preparation

A quality control method and preparation technology, applied in the field of medicine, can solve the problems of long analysis time, insufficient comprehensiveness, and few common peaks, etc., and achieve the effects of shortening analysis time, good quality of medicinal materials, and cost saving.

Inactive Publication Date: 2019-01-22
REYOUNG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, CN 201710087201.3 and CN 201710087162.7 disclose the establishment method and fingerprint spectrum of Ji Chuan Jian, which uses high performance liquid chromatography (HPLC) to establish the fingerprint of Ji Chuan Fried. There are 10 common peaks in total. The number of peaks is relatively small, and the compound information that can be obtained is relatively small; in addition, it takes 80 minutes to analyze a batch of samples, and the analysis time is too long, which is not suitable for components with poor stability; If the chemical structure of the peak is identified, the structural information of the compound cannot be obtained from the fingerprint alone, and the main chemical components in Jichuan Jian cannot be known, which is not comprehensive enough for the quality control of the drug

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  • Mass control method of Jichuan decoction preparation
  • Mass control method of Jichuan decoction preparation
  • Mass control method of Jichuan decoction preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Fingerprint of Jichuan Decoction

[0065] 1. Instruments and reagents

[0066] Ultra-high performance liquid chromatography (Waters Acquity H-Class), analytical balance (METTLER TOLEDO XS / 205DU), ultrasonic cleaning machine (KQ-5200E);

[0067] Chromatographic column: C18 column (Waters ACQUITY UPLC HSS T3 (2.1*50mm, 1.8μm);

[0068] Reagents: Acetonitrile is chromatographically pure, water is ultrapure water; other reagents are analytically pure, and reference materials are purchased from China National Institute for Food and Drug Control;

[0069] Reagent: Jichuanjian Granules (batch number: 17090401-17090408);

[0070] 2. Chromatographic conditions: use 0.1% formic acid aqueous solution as mobile phase A, acetonitrile as mobile phase B, gradient elution conditions are 0~1.04min, 15%B, 1.04~5.60min, 15%–16%B, 5.60~ 10.42min, 16%–25%B, 10.42~13.55min, 25%–95%B, 13.55~13.76min, 95-15%B, 13.76~20min, 15%B. The flow rate is 0.2ml / min; the column temperature is 25°C; t...

Embodiment 2

[0084] Fingerprint of Jichuan Decoction

[0085] 1. Instruments and reagents

[0086] Ultra-high performance liquid chromatography (Waters Acquity H-Class), analytical balance (METTLER TOLEDO XS / 205DU), ultrasonic cleaning machine (KQ-5200E);

[0087] Chromatographic column: ACQUITY UPLC BEH C18 (2.1*50mm, 1.7μm);

[0088] Reagents: Acetonitrile is chromatographically pure, water is ultrapure water; other reagents are analytically pure, and reference materials are purchased from China National Institute for Food and Drug Control;

[0089] Reagent: Jichuanjian Granules (batch number: 17090401-17090408);

[0090] 2. Chromatographic conditions: use 0.1% phosphoric acid aqueous solution as mobile phase A, acetonitrile as mobile phase B, gradient elution conditions are 0~1.04min, 12%B, 1.04~5.60min, 12%–16%B, 5.60~ 10.42min, 16%–24%B, 10.42~13.55min, 24%–95%B, 13.55~13.76min, 95-12%B, 13.76~17min, 12%B. The flow rate is 0.5ml per minute; the column temperature is 35°C; the dete...

Embodiment 3

[0098] Fingerprint of Jichuan Decoction

[0099] 1. Instruments and reagents

[0100] Ultra-high performance liquid chromatography (Waters Acquity H-Class), analytical balance (METTLER TOLEDO XS / 205DU), ultrasonic cleaning machine (KQ-5200E);

[0101] Chromatographic column: Aglient Poroshell 120EC-C18 (3.0*50mm, 2.7μm);

[0102] Reagents: Acetonitrile is chromatographically pure, water is ultrapure water; other reagents are analytically pure, and reference materials are purchased from China National Institute for Food and Drug Control;

[0103] Reagent: Jichuanjian Granules (batch number: 17090401-17090408)

[0104] 2. Chromatographic conditions: use 0.1% acetic acid aqueous solution as mobile phase A, acetonitrile as mobile phase B, gradient elution conditions are 0-2min, 10-13% B, 2-6.25min, 13%-18% B, 6.25 ~10.42min, 18%–24%B, 10.42~13.55min, 24%–95%B, 13.55~13.76min, 95%–10%B, 13.76~17min, 10%B. The flow rate is 0.3ml per minute; the column temperature is 30°C; the de...

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Abstract

The invention belongs to the technical field of drugs and specifically relates to a mass control method of a Jichuan decoction preparation. The mass control method of the Jichuan decoction preparationcomprises a fingerprint spectrum and a content measurement and identification method. The fingerprint spectrum of the Jichuan decoction preparation is built by adopting an ultra-high performance liquid chromatography. The mass control method comprises the steps of preparing a to-be-measured sample; and performing similarity calculation of the chromatogram map of the to-be-measured sample and a standard contrast fingerprint spectrum. The mass control method of the Jichuan decoction preparation provided by the invention is scientific, reasonable, simple and practicable, can control the mass ofdrugs more comprehensively and more efficiently, shortens the working time and increases the working efficiency.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a quality control method of Jichuan decoction preparation. Background technique [0002] The prescription of Jichuan decoction comes from Volume 51 of "Jingyue Quanshu". It is a classic prescription for clinical use. It has the functions of warming the kidney and replenishing the essence, moistening the intestines and laxatives. It is mainly used to treat constipation caused by deficiency of kidney yang and insufficient essence, clear and long urine, soreness and weakness of the waist and knees, pale tongue with white coating, deep and slow pulse. Clinically, it is often used to treat constipation in the elderly, habitual constipation, and postpartum women with weak kidney qi and constipation, etc. who belong to kidney deficiency, body fluid deficiency and intestinal dryness. [0003] In the traditional medicine of traditional Chinese medicine, decoction is still d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 苗得足胡清文焦启扬周现滢曹桂东曾丽丽
Owner REYOUNG PHARMA
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