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Detection method of Houttuynia herb injection

A technology of Houttuynia cordata injection and detection method, which is applied in the direction of measuring devices, material inspection products, testing pharmaceutical preparations, etc., and can solve the problems of effective control of product physical and chemical properties and effectiveness, low limit value, and low specificity

Inactive Publication Date: 2012-01-18
HUNAN ZHENGQING PHARM GRP CO LTD +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The legal quality standard comes from the ministerial standard "Prescription of Traditional Chinese Medicine" Volume 17 WS3-B-3264-98, and the national drug standard revision approval document 2001ZB0086. The content determination item in the legal quality standard is only for the determination of methyl nonanone The standard does not contain the control items of the fingerprint of traditional Chinese medicine, the control of the amount of volatile oil is not carried out, and the identification items only include two chemical reaction identifications with low specificity and a single The TLC identification test of the ingredients, the current statutory quality can not effectively control the physical and chemical properties and effectiveness of the product

Method used

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  • Detection method of Houttuynia herb injection
  • Detection method of Houttuynia herb injection
  • Detection method of Houttuynia herb injection

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0050] Experimental example 1 Houttuynia herba medicinal material and the content determination method of injection

[0051] 1.1 Chemical composition research

[0052] Houttuynia cordata fresh grass (fresh grass produced in Huaihua, Hunan Province, provided by Hunan Zhengqing Pharmaceutical Group Co., Ltd.) was analyzed by GC-MS for the volatile components of the pure product extracted under the specified test conditions. The total ion current spectrum is shown in image 3 , it can be seen from the figure that the volatile oil of Houttuynia cordata has complex components, containing nearly hundreds of chromatographic peaks, and dozens of chromatographic peaks with relatively large content.

[0053] Figure 4 It is the fingerprint GC-MS spectrum of the finished product of Houttuynia cordata injection. Based on the combined chromatography, it can provide the elution chromatogram information of the components and the mass spectrum information at different retention times (the st...

experiment example 2

[0207] Experimental Example 2 Study on the Fingerprint Detection Method of Houttuynia Herb and Injection

[0208] 2.1. Detection method of Houttuynia cordata

[0209] 2.1.1. Determination of chromatographic column

[0210] Investigated respectively HP-5, DB-1, DB-17 capillary column, its typical chromatogram (see Figure 9 ).

[0211] The results showed that the separation effect was the best on the DB-1 chromatographic column, so the DB-1 capillary column was used as the chromatographic column for fingerprint research.

[0212] 2.1.2. Determination of programmed temperature rise

[0213] A variety of temperature programming methods were selected during the experiment:

[0214] 1.70℃(12min)-10℃ / min-250℃

[0215] 2.70℃(10min)-20℃ / min-130℃-5℃ / min-140℃-20℃ / min-230℃

[0216] 3.70℃(10min)-5℃ / min-130℃-2℃ / min-140℃-20℃ / min-230℃

[0217] 4.70℃(10min)-5℃ / min-140℃-10℃ / min-230℃

[0218] 5.70℃(5min)-5℃ / min-140℃-10℃ / min-250℃

[0219] 6.70°C (10min)-5°C / min-140°C (5min)-10°C / min-250...

experiment example 3

[0285] Experimental example 3 Limit inspection of polysorbate 80 in Houttuynia cordata injection

[0286] Academician Li Liandai's studio has proved through safety experiments that polysorbate 80 is the main substance that causes allergic reactions of Houttuynia cordata injection, and has a dose-effect relationship. Low concentration polysorbate 80 (0.3%) is safe, so It is necessary to strictly limit the content of polysorbate 80 in Houttuynia cordata injection.

[0287] 3.1. Instruments and reagents:

[0288] UV-265FW ultraviolet spectrophotometer (Shimadzu, Japan); Polysorbate 80 reference substance; Houttuynia cordata injection (batch number: 090916-090935, 0907401-0907406, 0907410, 0904401, 0904404, 0904407), Houttuynia cordata distillate (Lot No. 090910). Cobalt nitrate (Tianjin Ruijinte Chemical Co., Ltd.), ammonium thiocyanate (Tianjin Botong Chemical Co., Ltd.), dichloromethane (Tianjin Damao Chemical Reagent Factory), analytically pure, water is self-made redistille...

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Abstract

The invention discloses a quality detection method of a Houttuynia herb injection. The method comprises content measurement, identification and / or fingerprint detection processes. The method is a gas chromatography, comprising the following steps of: taking a 4-terpineol reference substance, an alpha-terpinol reference substance, a bronyl acetate reference substance and methylnnonylketone, respectively adding n-hexane to prepare a reference substance solution; adding the n-hexane in the Houttuynia herb injection, adding anhydrous sulfate to prepare a test sample solution; respectively absorbing the reference substance solution and the test sample solution; injecting in the gas chromatography to test; and detecting according to the method of content measurement items, and recording a chromatogram, wherein the similarity of the test sample fingerprint and the reference fingerprint is not less than 0.85. The invention further provides a detection method of polysorbate 80 limit test in the Houttuynia herb injection, an identification method of thin-layer chromatography and a detection method of essential oil content in Houttuynia herb medical materials or injections. The quality detection method provided by the invention has good specificity, good linear relation, good instrument precision and good repeatability.

Description

technical field [0001] The invention relates to a quality detection method of injection, in particular to a quality detection method of Houttuynia cordata injection. Background technique [0002] Houttuynia cordata is the rooted whole plant of Houttuynia cordata Thunb., a perennial herbaceous plant of the family Tribaceae, also known as Pleurotus chinensis, Purple Houttuynia, Pig Nostril, Jiujielian, etc. Its fresh plants have a pungent fishy smell after being broken , widely distributed in the central, southeast and southwest provinces of my country, especially in Hunan, Hubei, Sichuan, Jiangsu and other provinces. Houttuynia cordata has the effects of clearing heat and detoxifying, eliminating carbuncle and draining pus, diuresis and treating stranguria. It is clinically used for lung abscess and vomiting of pus, phlegm-heat wheezing and coughing, hot dysentery, hot stranguria, carbuncle and sore. Studies have shown that the volatile components contained in Houttuynia cord...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/90G01N21/33G01N33/15
Inventor 毕开顺吴飞驰潘红炬李清仇萍朱雅宁李苏翠吴建国
Owner HUNAN ZHENGQING PHARM GRP CO LTD
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