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Method for determining contents of soluble arsenic and valence-state arsenic in realgar-containing medicine

A soluble and realgar technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of lack of scientific basis, unscientific, and safety issues in usage and dosage, and achieve the effect of filling the gap in China and sensitive methods

Active Publication Date: 2012-09-26
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Due to the lack of scientific basis for usage and dosage, it is difficult to reasonably evaluate its safe dose, and the problem of drug safety has been plagued by my country's traditional Chinese medicine industry
[0004] 2. The unknown material basis of the efficacy and toxicity of realgar has seriously hindered its international recognition:
The current quality standard of realgar only controls the total amount of arsenic, but does not control the content of soluble arsenic and valence arsenic, which cannot reflect the actual application of realgar in the human body. It is unreasonable to measure whether it is safe or not by the total amount of elements. not scientific
[0006] 3. The existing quality standards of realgar cannot reflect the effectiveness and safety, and there is no basis for usage and dosage:
[0007] my country's 2010 edition of "Chinese Pharmacopoeia" contains only the content determination method of redox titration under the item of realgar; it lacks scientific quality control methods for effective ingredients and limited control methods for toxic ingredients; and its usage and dosage lack scientific basis , it is urgent to further improve the
[0008] 4. A large number of realgar-containing preparations lack relevant research and quality control methods, leading to safety problems in practical applications:
Through literature review, it is found that the methods of soluble arsenic in realgar reported in each literature are basically similar, and artificial gastric juice or artificial intestinal juice is used as the extraction solvent, but the obtained soluble arsenic content is quite different

Method used

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  • Method for determining contents of soluble arsenic and valence-state arsenic in realgar-containing medicine
  • Method for determining contents of soluble arsenic and valence-state arsenic in realgar-containing medicine
  • Method for determining contents of soluble arsenic and valence-state arsenic in realgar-containing medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Determination of the content of soluble arsenic in realgar medicinal materials: according to inductively coupled plasma mass spectrometry (Appendix XI D of Chinese Pharmacopoeia 2010 edition).

[0064] Reagents and Instruments

[0065] American Agilent 7700ce inductively coupled plasma mass spectrometer; Branson Ultrasound (Shanghai) Co., Ltd. B9500S-DTH ultrasonic cleaner (power 300W, frequency 45kHz); American Millipore Milli-Q ultrapure water machine. Arsenic standard solution (1000mg / L, batch number HC961324) was purchased from Merk Company.

[0066] Both nitric acid and hydrochloric acid are superior grade pure (Merck company); pepsin is a biochemical reagent, the enzyme activity is 1:27000, and the batch number is 100710, purchased from Shanghai Huixing Biochemical Reagent Co., Ltd.; pancreatin is a biochemical reagent, and the casein conversion capacity ≥25.0, the batch number is F20100714, purchased from Sinopharm Chemical Reagent Co., Ltd.; the water is deioni...

Embodiment 2

[0113] Determination of soluble arsenic in realgar decoction pieces: according to inductively coupled plasma mass spectrometry (Appendix XI D of Chinese Pharmacopoeia 2010 edition).

[0114] The realgar medicinal material in Example 1 was replaced with realgar decoction pieces (sourced from Hunan Shimen Realgar Mining Industry, processed by Shanghai Fengbang Traditional Chinese Medicine Decoction Pieces Factory, batch number H2008081202), and the rest of the methods and processes were the same as in Example 1.

[0115] Solution Stability Test

[0116] Get the realgar decoction pieces, prepare the test solution in the same way as in Example 1 "Measurement of soluble arsenic in the realgar medicinal material" to prepare the test solution, analyze at different times, measure the amount of soluble arsenic, the results show (see table 5), the content of soluble arsenic in the test solution is basically stable within 0 to 24 hours.

[0117] Table 5, solution stability test (soluble...

Embodiment 3

[0152] Determination of soluble arsenic in realgar preparations: determined by inductively coupled plasma mass spectrometry (Appendix XI D of Chinese Pharmacopoeia 2010 edition).

[0153] The preparation of need testing solution: get bureau prescription Zhibaosan (Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd. provides, batch number 4) 150mg, research fine, accurately weighed, (1) put 250ml glass measuring bottle (first use 20% hydrochloric acid Solution (v / v) soaked overnight, then washed with deionized water and dried), added artificial intestinal juice to the scale, shaken, sealed, weighed, placed in 37 ° C for ultrasonic treatment (power 300W, frequency 45kHz) for 2 hours, shake once every 10-15 minutes, or (2) put a 250ml ~ 500ml stoppered Erlenmeyer flask (soak in 20% hydrochloric acid solution (v / v) overnight, then deionized water Wash and dry), add 250ml of artificial intestinal juice, shake well, weigh, place in a 37°C water bath with magnetic stirring (adjust the numb...

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Abstract

The invention discloses a method for determining the content of soluble arsenic in a realgar-containing medicine and is characterized in that the method comprises the following steps of: (1) extracting soluble arsenic in the realgar-containing medicine by bionic solvent-ultrasonic treatment and / magnetic stirring; (2) alternatively purifying a solution obtained by extraction in the step (1); and (3) determining the content of soluble arsenic in the realgar-containing medicine by an ICP-MS method. The invention also discloses a method for determining the content of soluble valence-state arsenic in the realgar-containing medicine. By the adoption of the extraction mode for simulation in vivo, ICP-MS and HPLC-ICP-MS, the method for determining drug effects of realgar and main toxic components is established, and the method is sensitive and accurate.

Description

technical field [0001] The invention relates to a method for determining the content of soluble arsenic in realgar-containing medicines by using the bionic extraction-ICP-MS method, and also relates to a method for determining the soluble valence state in realgar-containing medicines by using the bionic extraction-HPLC-ICP-MS method method for arsenic content. Background technique [0002] Realgar is a commonly used mineral traditional Chinese medicine in my country. It has been clinically used for thousands of years. The earliest record of its medicinal use is "Shen Nong's Herbal Classic". It can be taken internally and externally and has a wide range of uses. Traditional medicine believes that realgar has the functions of detoxifying and killing insects, drying dampness and eliminating phlegm, and cutting off malaria. Since the 1950s, domestic doctors have used realgar-containing compound preparations or single prescriptions to treat blood system diseases, malignant lymph...

Claims

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Application Information

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IPC IPC(8): G01N30/72
Inventor 季申王欣美夏晶王柯李丽敏张甦王枚博毛秀红吴赵云郑荣胡青郏征伟苗水陆继伟陈铭于建简龙海钟吉强孙健孟茜毛丹许勇王少敏张道广陈静
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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