HPLC fingerprint detection method of kidney-tonifying and bone-strengthening traditional Chinese medicine

A technology of fingerprint, invigorating kidney and strengthening bones, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of time-consuming and labor-intensive detection, threat to drug safety, low efficiency, etc., to achieve convenient operation, avoid adulteration of traditional Chinese medicine, use Instrument-less effect

Active Publication Date: 2020-03-24
JIANMIN PHARMA GRP CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] CN 1493325A discloses a traditional Chinese medicine for treating primary osteoporosis with deficiency syndrome of liver and kidney and its preparation method. It is composed of traditional Chinese medicinal materials, and the trade name is "Bushen Jiangu Capsule". There are great limitations in the control. First, it cannot fully characterize the quality of medicines, leading to serious adulteration and inferiority of traditional Chinese medicines, which not only cannot guarantee the curative effect of traditional Chinese medicines, but also seriously threatens the safety of medications. Secondly, this method also has many detection times. , many instruments, time-consuming and labor-intensive detection, low efficiency and other shortcomings

Method used

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  • HPLC fingerprint detection method of kidney-tonifying and bone-strengthening traditional Chinese medicine
  • HPLC fingerprint detection method of kidney-tonifying and bone-strengthening traditional Chinese medicine
  • HPLC fingerprint detection method of kidney-tonifying and bone-strengthening traditional Chinese medicine

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] 1. Instruments and reagents

[0039] DIONEX P680 high performance liquid chromatograph, quaternary pump, online vacuum degassing system, autosampler, column thermostat, UV detector; AB204-E electronic balance (Shanghai Mettler-Toledo Instrument Co., Ltd.).

[0040] 10 batches of Bushen Jiangu Capsules (190201-03, 190404-05, 190706-10, a total of 10 batches); icariin reference substance (for content testing, purchased by China Institute for Food and Drug Control, batch number: 110737- 200415); acetonitrile was chromatographic grade, water was purified water, and the rest were chemical grade.

[0041] 2. Method steps

[0042] (1) Preparation of the test solution: Grind the contents of the Bushen Jiangu Capsules to be tested finely, take 1.5g, accurately weigh, add 30ml of 50% methanol accurately, weigh, ultrasonic 30 minutes (power 250W, frequency 40kHz), let it cool, and then weigh it, make up the lost weight with 50% methanol, shake well, filter, and take the filtrate...

Embodiment 2

[0048] Embodiment 2 detection condition optimization

[0049] 1. Preparation of the test solution

[0050] According to the prescription and preparation characteristics of Bushen Jiangu Capsules, 50% methanol and 50% ethanol were respectively investigated as extraction solvents to prepare the test solution. Refer to Example 1 for specific methods.

[0051] Column: Agilent ZORBAX SB-C 18 , 4.6×250mm, 5um; detection wavelength: 235nm; injection volume 10ul; column temperature: 30°C; flow rate: 1ml / min; mobile phase A: acetonitrile, mobile phase B: containing 0.1% potassium dihydrogen phosphate and 0.05% octane Aqueous solution of sodium alkanesulfonate, the gradient elution program is shown in Table 1.

[0052] From figure 1 and image 3 It can be seen that the chromatographic peak area of ​​the resulting test solution extracted by 50% methanol is larger, and the separation effect of the three peaks in 40-45 minutes is better, so it is determined that 50% methanol is used as ...

Embodiment 3

[0060] Embodiment 3 methodological investigation

[0061] 1. Stability test

[0062] Get the test solution according to the above-mentioned chromatographic conditions, measure at 0, 4, 8, 12h, 24h, investigate the relative retention time of each common peak and the RSD of the relative peak area. The results show that the relative retention time of each chromatographic peak is less than 2.0%, and the relative peak area of ​​each chromatographic peak is less than 2.0%, which meet the technical requirements of fingerprint. See Table 3-4.

[0063] Table 3 Bushen Jiangu Capsule Stability Investigation Relative Retention Time

[0064]

[0065] Table 4 Relative peak area of ​​Bushen Jiangu Capsule Stability Investigation

[0066]

[0067] 2. Repeatability test

[0068] Get 6 parts of samples of the same batch number, prepare 6 parts of need testing solution according to the preparation method of need testing solution under item 1, measure under the above-mentioned chromatog...

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Abstract

The invention relates to an HPLC fingerprint detection method of a kidney-tonifying and bone-strengthening traditional Chinese medicine. The kidney-tonifying and bone-strengthening traditional Chinesemedicine is prepared from prepared rehmannia roots, dogwood, rhizoma cibotii, herba epimedii, Chinese yams, angelica sinensis, moutan bark, oysters and other traditional Chinese medicinal materials.The detection method comprises the following steps: extracting a sample, and detecting the sample by using a high performance liquid chromatograph, wherein the high performance liquid chromatograph comprises an ultraviolet detector, the set detection wavelength of the ultraviolet detector is 220-250nm, the stationary phase of the high performance liquid chromatograph is a C18 chromatographic column, the mobile phase A is acetonitrile, the mobile phase B is an aqueous solution containing 0.05-0.3% of potassium dihydrogen phosphate and 0.01-0.1% of sodium octanesulfonate, and gradient elution isadopted. Nine common peaks are marked in the established fingerprint spectrum, the sixth peak is the icariin peak, methodological investigation shows that the nine common peaks have very high stability, repeatability and precision, and the method can be completely used for guiding production and controlling product quality.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine detection, and relates to an HPLC fingerprint detection method of traditional Chinese medicine for invigorating kidney and strengthening bones. Background technique [0002] CN 1493325A discloses a traditional Chinese medicine for treating primary osteoporosis with deficiency syndrome of liver and kidney and its preparation method. It is composed of traditional Chinese medicinal materials, and the trade name is "Bushen Jiangu Capsule". There are great limitations in the control. First, it cannot fully characterize the quality of medicines, leading to serious adulteration and inferiority of traditional Chinese medicines, which not only cannot guarantee the curative effect of traditional Chinese medicines, but also seriously threatens the safety of medications. Secondly, this method also has many detection times. , many instruments, time-consuming and labor-intensive detection, low effic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/36G01N30/34G01N30/74G01N30/8686G01N2030/027
Inventor 陈鹏李霞陈骞明凯利熊丽向阳
Owner JIANMIN PHARMA GRP CO LTD
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