Detection method of Ziyedan capsule

A detection method, the technology of Ziyedan, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of prolonging the production time, complicated operation of the detection method, increasing the production time and cost, etc.

Pending Publication Date: 2021-11-19
BEIJING RED SUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing detection method is complicated to operate, and different components need to be measured separately. The detection time is too long, which prolongs the production time to a certain extent, and increases the production time and cost of each batch.

Method used

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  • Detection method of Ziyedan capsule
  • Detection method of Ziyedan capsule
  • Detection method of Ziyedan capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0141] Embodiment 1: Ziyedan ​​Capsules HPLC Fingerprint Detection Method

[0142] 1. Instruments and materials:

[0143] Ziyedan ​​Capsules (Beijing Handian Pharmaceutical Co., Ltd., batch number: 210101)

[0144] Methanol (chromatographically pure, Honeywell, lot No: UC3G1H)

[0145] Phosphoric acid (AR, Tianjin Fuchen Chemical Reagent Co., Ltd., batch number: 20180420)

[0146] Electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd., BSA224S)

[0147] Ultrasonic cleaner (Kunshan Ultrasonic Instrument Co., Ltd., KQ500DE)

[0148] High performance liquid chromatography (Agilent 1260Infinity, HPLC-2, VWD)

[0149] Chromatographic column (Welch 100-5-C 18, 250×4.6mm, 5μm)

[0150] 2. Experimental process:

[0151] Preparation of the test solution: take the contents of 210101 batches of Ziyedan ​​capsules, grind finely, weigh 0.5g, accurately weigh, put in a conical flask, accurately measure 50ml of 75% methanol, ultrasonicate for 30min, filter, and take ...

Embodiment 2

[0159] 1 Precision test

[0160] Take the test sample of Ziyedan ​​Capsules (batch number: 210101) of the same batch number, prepare the sample solution according to the proposed extraction method, take 10 μl and inject it into the liquid chromatograph, inject the sample 6 times continuously, record the chromatogram, and use the fingerprint similarity software Calculation, the measured chromatogram similarity calculation results are all 1.000 (with S1 as a reference, figure 2 ), indicating that the method is accurate and reliable.

[0161] 2 Repeatability test

[0162] 6 copies of the test sample of the same batch number Ziyedan ​​Capsules (batch number: 210101), prepared the sample solution according to the proposed extraction method, each took 10 μl and injected it into the liquid chromatograph, recorded the chromatogram, calculated by the fingerprint similarity software, and measured The similarity calculation results of the chromatograms are all greater than 0.997 (with...

Embodiment 3

[0165] Example 3: Ziyedan ​​Capsule Standard Fingerprint Establishment Method

[0166] 1. Instruments and materials:

[0167] Ziyedan ​​Capsules (Beijing Handian Pharmaceutical Co., Ltd., batch numbers: 190401, 190402, 190701, 190901, 191201, 200401, 210101)

[0168] Methanol (chromatographically pure, Honeywell, lot No: UC3G1H)

[0169] Phosphoric acid (AR, Tianjin Fuchen Chemical Reagent Co., Ltd., batch number: 20180420)

[0170] Electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd., BSA224S)

[0171] Ultrasonic cleaner (Kunshan Ultrasonic Instrument Co., Ltd., KQ500DE)

[0172] High performance liquid chromatography (Agilent 1260Infinity, HPLC-2, VWD)

[0173] Chromatographic column (Welch 100-5-C 18, 250×4.6mm, 5μm)

[0174] 2. Experimental process:

[0175] Preparation of the test solution: take the contents of 7 batches of Ziyedan ​​capsules, grind finely, weigh 0.5g, accurately weigh, put in a conical flask, accurately measure 50ml of 75% metha...

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Abstract

The invention relates to a detection method of a Ziyedan capsule. The detection method comprises the following steps of: preparing a standard solution: taking a proper amount of tanshinone IIA reference substance, precisely weighing, adding methanol to prepare a standard mother solution, and then adding 75% methanol to dilute to a corresponding concentration; preparing a test solution, taking capsule contents, adding 75% methanol for extraction, filtering, taking a subsequent filtrate, and detecting by adopting high performance liquid chromatography. The method can rapidly and accurately determine the contents of three index components in the Ziyedan capsule at the same time, and is high in precision, good in stability and excellent in repeatability; and meanwhile, the detection time can be greatly shortened, the usage amount of reagents and standard substances is saved; the invention further provides a fingerprint spectrum method of the Ziyedan capsule, the product quality is controlled through a fingerprint spectrum comparison method, the stable product quality can be more effectively guaranteed, and then the safety and effectiveness of the product are guaranteed.

Description

Technical field: [0001] The invention relates to a detection method of traditional Chinese medicine, in particular to a detection method of Ziyedan ​​capsule, which adopts high performance liquid chromatography. Background technique: [0002] Ziyedan ​​Capsule is a Chinese patent medicine that has been on the market. The formula is: Yexiazhu 2100g, Yunzhi 800g, Salvia miltiorrhiza 200g, and Comfrey 200g. It has the effects of clearing liver and detoxifying, promoting blood circulation and removing blood stasis. It is used for patients with chronic hepatitis B whose syndrome is of damp-heat accumulation and qi deficiency and blood stasis. Symptoms: abdominal fullness, hypochondriac pain, loss of appetite, fatigue, bitter taste, etc. [0003] Determination conditions for the content of each index component in the original standard [0004] [0005] The existing detection method is complicated to operate, and different components need to be measured separately. The detecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/86
CPCG01N30/88G01N30/8686G01N2030/027G01N2030/8809
Inventor 林德良
Owner BEIJING RED SUN PHARMA
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