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Method for rapidly measuring concentration of trichloro-tert-butyl alcohol in posterior pituitary injection

A technology for chlorobutanol and posterior pituitary, which is applied in the field of chlorobutanol concentration determination and achieves the effects of simple quantitative analysis, convenient operation and high efficiency

Inactive Publication Date: 2015-11-25
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no research report on the quantitative analysis of chlorobutanol in the posterior pituitary injection by Raman spectroscopy

Method used

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  • Method for rapidly measuring concentration of trichloro-tert-butyl alcohol in posterior pituitary injection
  • Method for rapidly measuring concentration of trichloro-tert-butyl alcohol in posterior pituitary injection
  • Method for rapidly measuring concentration of trichloro-tert-butyl alcohol in posterior pituitary injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1 3

[0082] The establishment of embodiment 1 chlorobutanol standard curve

[0083] 1. Sample Preparation

[0084] Prepare different concentrations of chlorobutanol standard solutions, the concentrations are 0.0500%, 0.1000%, 0.2008%, 0.3013%, 0.4017%, 0.5001%, 0.6025% 0.2% HAC solution, and put them into unified standard bottles.

[0085] The posterior pituitary injection used in this method is a commercially available sample of different brands, different concentrations, and different batches, a total of 35 samples, and the detailed information of the samples is shown in Table 1.

[0086] Table 1. Sample information table

[0087] serial number production unit batch 1 Anhui Hongye Pharmaceutical Co., Ltd. 10 2 Nanjing Xinbai Pharmaceutical Co., Ltd. 14 3 Tianjin Biochemical Pharmaceutical Co., Ltd. 2 4 Shanghai First Biochemical Pharmaceutical Co., Ltd. 9

total 35

[0088] 2. Spectrum collection

[0089] detected with a R...

Embodiment 2

[0094] The concentration prediction of embodiment 2 test sample

[0095] The quantitative analysis model established above was used to measure the commercially available posterior pituitary injection, and compared with the measurement results of gas chromatography. The results are shown in Table 2.

[0096] Table 2

[0097]

[0098] In the table, the predicted value is the result obtained by using Raman spectroscopy combined with chemometric methods (PLS method and PCR method), and the measured value is the result measured by gas chromatography (the method of the Chinese Pharmacopoeia).

[0099] If the predicted value is negative, the result is expressed as 0.000 in the table, and if the predicted value is positive and the concentration is less than 0.05%, it is not detected. Because the linear range of the chlorobutanol standard curve prepared by this method is 0.05%-0.6% (the scope of commonly used antibacterial agents in the Pharmacopoeia is 0.5% chlorobutanol), the pre...

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Abstract

The invention relates to a method for measuring the concentration of trichloro-tert-butyl alcohol, and especially relates to a method for rapidly measuring the concentration of trichloro-tert-butyl alcohol in a posterior pituitary injection. The method comprises the following steps: step one, preparing a series of trichloro-tert-butyl alcohol standard solutions with increasing concentrations; step two, receiving spectroscopic data of trichloro-tert-butyl alcohol standard solutions from a Raman spectrometer; step three, establishing a PLS or PCR quantitative model according to the trichloro-tert-butyl alcohol spectrum obtained in the step two; step four, obtaining the Raman spectrum of a posterior pituitary injection sample to be measured; step five, using the PLS or PCR quantitative model to predict the concentration of the sample. The provided method reduces the work load, improves the detection efficiency, and accelerates the speed.

Description

technical field [0001] The invention relates to a method for measuring the concentration of chlorobutanol, in particular to a method for measuring and analyzing the concentration of chlorobutanol in an injection. Background technique [0002] Injections are the most commonly used sterile preparations. The purpose of adding bacteriostatic agents is to ensure that the preparations are free from microbial contamination, thereby ensuring the safety and effectiveness of the drugs. At the same time, attention must be paid to the toxicity of the bacteriostatic agents themselves, and attention must be paid to them during use. Dosage, not only to achieve the purpose of adding, but also to minimize the harm, so it is necessary to establish effective supervision and inspection methods. [0003] The pharmacopoeias of various countries have paid attention to the effectiveness of antibacterial agents. The United States Pharmacopoeia first proposed the inspection of the efficacy of antibac...

Claims

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Application Information

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IPC IPC(8): G01N21/25
Inventor 杨永健毛丹卓翁欣欣
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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