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Method for improving detection accuracy and precision of content of cinnamic acid in Mailuoning injection intermediate extract

A technology for detection accuracy and intermediates, which is applied in the field of improving the detection accuracy and precision of cinnamic acid content in Mailuoning injection intermediate extract, can solve the problems of low extraction degree, long preparation time, poor repeatability, etc., and achieve The effect of improving work efficiency, shortening preparation time, improving dissolution rate and dissolution repeatability

Active Publication Date: 2021-06-25
JINLING PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] In view of the deficiencies in the existing problems, the purpose of the present invention is to provide a method for improving the detection accuracy and precision of cinnamic acid content in Mailuoning injection intermediate extract; by improving the preparation method of the test solution, formulating Mailuoning Validation of the HPLC method for the extraction of cinnamic acid from injection solution, while solving the problems of long preparation time, low extraction degree and poor repeatability of the existing technology

Method used

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  • Method for improving detection accuracy and precision of content of cinnamic acid in Mailuoning injection intermediate extract
  • Method for improving detection accuracy and precision of content of cinnamic acid in Mailuoning injection intermediate extract
  • Method for improving detection accuracy and precision of content of cinnamic acid in Mailuoning injection intermediate extract

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: adopt the method for heating and dissolving in a water bath to mix the extract evenly

[0030] The intermediate of Mailuoning injection is ester extraction extract, the upper layer is a heterogeneous solution, and the lower layer is sediment; the extract is mixed evenly by heating and dissolving in a water bath, and the supernatant is filtered by shaking method and ultrasonic method for comparison, the specific preparation method of the test product is shown in Table 1, and the test results are as follows: figure 1 . The sample batch number is 20190202B.

[0031] Table 1 The test result table obtained by different sample extraction methods

[0032]

[0033]

[0034] It can be seen from Table 1 that the RSDs of the test results were all less than 2% by heating and dissolving in a water bath, and the repeatability reached expectations.

Embodiment 2

[0035] Embodiment 2: compare the dissolution effect and HPLC peak shape of three solvents of water, methanol and mobile phase

[0036] On the basis of heating and dissolving in a water bath in Example 1, a 0.1% phosphoric acid-methanol solution with a volume ratio of methanol, ethanol, and HPLC mobile phase of 40:60 was selected for comparison with the solvent water in the original extraction method. The test results are shown in Table 2, and the sample batch number is 20190203B.

[0037] Table 2 The detection results of different solvents

[0038]

[0039] As shown in Table 2, the solvent contains an aqueous phase, and the solubility of cinnamic acid is reduced. When methanol is used to dissolve and dilute, the amount of cinnamic acid dissolved is significantly increased, but the peak shape is as follows: figure 1 As shown, tailing, symmetry factor is 1.22; but using the mobile phase as the solvent, the HPLC peak shape is the most ideal, so two-step dilution is considered...

Embodiment 3

[0040] Embodiment 3: compare the extraction degree of various pretreatment methods

[0041] The original preparation method of the test solution is: put the product in a shaker at 30°C for 3 hours, take it out, accurately measure 0.5mL, put it in a 500mL measuring bottle, add water to dissolve and dilute to the mark, and shake well to get . Apply for the use of several new preparation methods for the test solution, sorted into Table 3.

[0042] Table 3 The extraction degree of various pretreatment methods

[0043]

[0044] As shown in Table 3, after the extract sample was placed in hot water for warm dissolution and shaking, the sample was mixed evenly, and then precisely measured, the content of cinnamic acid was greatly increased, and its repeatability was also significantly improved.

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Abstract

The invention discloses a method for improving the detection accuracy and precision of the content of cinnamic acid in a Mailuoning injection intermediate extract.The method comprises the following steps: preparing a test solution of cinnamic acid in the intermediate extract of the Mailuoning injection, and preparing the test solution by the following specific steps: taking a sample of the intermediate extract of the Mailuoning injection, dissolving the sample in a water bath at the temperature of 50-80 DEG C in a heating manner, uniformly mixing by shaking, precisely measuring 0.5 mL of the sample, placing the abve in a 500mL measuring flask, dissolving in water, diluting to a scale, and uniformly shaking, so that the extract is more uniformly mixed by adopting a hot water dissolving method. The extract extraction rate is increased from 0.395 mg / mL to 1.719 mg / mL, and the extraction degree is increased by 335%. According to the invention, a preferable method for dissolving and preparing the test sample is determined, and the preparation time of the test sample solution is reduced from 4 hours before improvement to 1 hour at present, so that the preparation time of the test sample solution is greatly shortened, and the working efficiency is improved; and the RSD of a detection result is less than 2 percent.

Description

technical field [0001] The invention belongs to the field of drug quality detection, and in particular relates to a method for improving the detection accuracy and precision of cinnamic acid content in Mailuoning injection intermediate extract. Background technique [0002] Mailuoning series products are the main products of Jinling Pharmaceutical Co., Ltd., of which Mailuoning injection is one of them. The prescription medicinal materials are Achyranthes bidentata, Scrophulariaceae, Dendrobium, honeysuckle, mountain silver flower, and the excipient is polysorbate 80. It is mainly used for clearing heat and nourishing yin, promoting blood circulation and removing blood stasis, and is used for thromboangiitis obliterans, arteriosclerotic obliterans, cerebral thrombosis and its sequelae, venous thrombosis and other diseases. Cinnamic acid is the main active ingredient in Scrophulariaceae. It has a laxative effect and is also a differentiation-inducing agent, which can induce t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06
CPCG01N30/06Y02A50/30
Inventor 施栋磊陶静美
Owner JINLING PHARMA
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