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Method for detecting liquid preparation by utilizing Raman spectra

A technology of Raman spectrum detection and liquid preparation, which is applied in the field of spectrum analysis, can solve problems such as large optical path of measurement, inability to obtain near-infrared spectrum, and near-infrared technology cannot be used as a general solution, so as to solve technical problems, The effect of broad application prospects

Active Publication Date: 2015-05-27
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The measured optical path depends on the diameter of the injection solution packaging bottle, usually because the liquid preparation packaging bottle is large (from 1mL to 500mL), so the measured optical path is too large to obtain the required near-infrared spectrum
Therefore, for liquid preparations, especially large-scale packaging, near-infrared technology cannot be used as a general solution

Method used

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  • Method for detecting liquid preparation by utilizing Raman spectra
  • Method for detecting liquid preparation by utilizing Raman spectra
  • Method for detecting liquid preparation by utilizing Raman spectra

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Embodiment 1: the detection of doxofylline injection

[0075] Taking doxofylline injection as an example, a grating-type Raman spectrometer, a 785nm laser, a laser power of 400mW, and an optical fiber probe were used for measurement, and the measurement time was 200s. According to the method described in the specific embodiment, the following Raman spectra about doxofylline are obtained: W (pure water), B (empty packaging bottle), DWB (through the packaging bottle of doxofylline injection, measured Obtain the overall non-destructive Raman spectrum), RDW (measure the aqueous solution prepared from the active ingredient standard of doxofylline, and obtain the Raman spectrum containing the active ingredient standard of doxofylline and water); and then subtract way to obtain D and RD Raman spectra ( figure 1 is the required spectrum calculated according to the formula ①CLS model; figure 2 is the required spectrum calculated according to the formula ②CLS model).

[0076]...

Embodiment 2

[0084] Embodiment 2: the detection of zinc gluconate oral liquid

[0085] According to the method of Example 1, each Raman spectrum of zinc gluconate oral liquid was obtained.

[0086] According to the Raman spectra obtained in this example, a Raman model was established, and three verification samples were selected for model verification. The calculated results are shown in the following table (Table 3):

[0087] table 3

[0088] sample

API name

correlation coefficient

i

j

l

p API value

1

Zinc gluconate

0.9465

0.2701

0.8352

1.359

0.3234

2

Zinc gluconate

0.9197

0.2455

0.9102

1.3879

0.2697

3

calcium gluconate

0.8031

/

/

/

/

[0089] Qualitative judgment based on the correlation coefficient: According to the calculation results of the correlation coefficient of the existing samples of zinc gluconate oral liquid are all above 0.90, and the reve...

Embodiment 3

[0094] Example 3: Large infusion of doxofylline and glucose in flexible packaging bag

[0095] According to the method of Example 1, each Raman spectrum of the soft-packed bag doxofylline glucose infusion was obtained.

[0096] Raman models were established based on the Raman spectra obtained in this example, and verification samples were selected for model verification. The calculated results are shown in the following table (Table 5):

[0097] table 5

[0098]

[0099] Qualitative judgment based on the correlation coefficient: if the correlation coefficient of the model verification sample is greater than or equal to the threshold value of 0.90, it can be identified as containing doxofylline, and if it is less than the threshold value of 0.90, it cannot be identified as not containing doxofylline; the above results show that samples 1 and 2 All can be identified as containing doxofylline; the excipient factor (glucose) shows that the sample also contains a certain concen...

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Abstract

The invention relates to a method for detecting a liquid preparation by utilizing Raman spectra, which comprises the following steps of: obtaining the following Raman spectra: a Raman spectrum of pure water, a Raman spectrum of an empty liquid preparation package and a Raman spectrum of the packaged liquid preparation; obtaining a Raman spectrum of active ingredients in the liquid preparation by spectrum subtraction; carrying out Raman detection on aqueous solution of a standard product of the active ingredients in the liquid preparation to obtain a reference Raman spectrum comprising the active ingredients and the water; obtaining a reference Raman spectrum of the active ingredients in the liquid preparation in a spectrum subtraction manner; carrying out Raman detection on aqueous solution of a reference substance of accessories in the liquid preparation to obtain a reference Raman spectrum comprising the accessories and the water; obtaining a reference Raman spectrum of the accessories in the liquid preparation by spectrum subtraction; and then carrying out qualitative identification and quantitative calculation. Compared with the prior art, the method well applies a Raman spectrum technology to carry out nondestructive testing on the liquid preparation, solves various technical problems and can have a wide application prospect.

Description

technical field [0001] The invention relates to the field of spectroscopic analysis, in particular to a method for detecting liquid preparations using Raman spectroscopy. Background technique [0002] In order to quickly screen counterfeit and shoddy injections, it is hoped that the active pharmaceutical ingredient (API) and excipients of the liquid preparation in the packaging bottle can be directly and non-destructively identified without destroying the package to take out the sample. [0003] Since near-infrared spectroscopy is an absorption spectrum, it is usually measured in transmission or transflectance for clear liquids. The measured optical path depends on the diameter of the injection solution packaging bottle. Usually, because the liquid preparation packaging bottle is large (from 1mL to 500mL), the measured optical path is too large to obtain the required near-infrared spectrum. Therefore, for liquid preparations, especially for large-scale packaging, near-infra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/65
Inventor 尹利辉赵瑜纪南王军高延甲朱俐张学博
Owner NAT INST FOR FOOD & DRUG CONTROL