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Quality controlling method of Bupleurum injection

A quality control method, the technology of Bupleurum injection, applied in the direction of measuring devices, testing pharmaceutical preparations, instruments, etc., can solve the problems of non-specific identification, affecting the clinical efficacy and safety of drugs, and unstable quality, so as to ensure clinical High curative effect, high stability and good repeatability

Inactive Publication Date: 2007-08-08
北京华医神农医药科技有限公司
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Problems solved by technology

However, our research shows that the detection of ultraviolet absorbance in this detection method is actually a reflection of the toxic component furfural, and this detection method has no more effective quality control methods such as specific identification and content determination; in addition, the injection used is The aromatic water obtained from the distillation of Bupleurum medicinal materials mainly contains volatile components, and its quality is more unstable, which seriously affects the clinical efficacy and safety of the drug

Method used

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  • Quality controlling method of Bupleurum injection
  • Quality controlling method of Bupleurum injection

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0021] Experimental Example 1, Establishment of Control Fingerprint of Bupleurum Injection

[0022] 1. Selection of detection method:

[0023] Bupleurum injection mainly contains volatile components, so it is more appropriate to use GC-FID method to establish fingerprints.

[0024] 2. Inspection of chromatographic column:

[0025] Respectively for Agilent HP-530m×0.32mm×0.25μm (weak polarity); Agilent DB-WAX 30m×0.53mm×1μm (strong polarity); Agilent DB-624 30m×0.32mm×1.8μm (non-polarity) Three kinds of gas-phase capillary columns were investigated, and the results showed that the non-polar DB-624 and weakly polar HP-5 capillary columns had better separation effects, and were suitable for the detection of the fingerprint of Bupleurum injection, among which HP-5 Capillary column (dimethylsiloxane as stationary phase) has the best separation effect.

[0026] 3. The preparation method of the test solution:

[0027] We investigated headspace sampling and manual sampling after o...

experiment example 2

[0046] Experimental Example 2, Methodological Investigation of Bupleurum Injection

[0047] precision test

[0048] The samples of the same batch number were selected for 5 continuous injections, the fingerprints were determined, and the fingerprint software was used to evaluate the similarity. The fingerprints and similarity are shown in Figure 3 and Table 3, respectively. It can be seen from Table 3 that the similarity is 1, indicating that the precision of the sample instrument is good.

[0049] Table 3 The similarity calculation results of the precision inspection of Bupleurum chinensis fingerprints

[0050] 1

[0051] 2. Stability test

[0052] Select the same sample solution to inject samples at 0, 1, 2, 4, and 8 hours respectively, measure the fingerprints, and use fingerprint software to evaluate the similarity. The fingerprints and similarity are shown in Figure 4 and Table 4, respectively. As can be seen from Table 4, the similarity is 1, indicating ...

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Abstract

The invention discloses Bupleurum injection quality control method. Bupleurum injection quality control method of this invention includes the following steps: the first step, using gas chromatography to establish Bupleurum injection comparison fingerprint pattern: the second step, according to the first step, measuring Bupleurum injection testing saple fingerprint pattern; the third step, calculating similarity of Bupleurum injection testing sample fingerprint pattern and comparison fingerprint pattern, and screening the samples according with Bupleurum injection fingerprint pattern detection standard as qualified products. Through the establishment of Bupleurum injection fingerprint pattern, the invention uses fingerprint pattern to control the quality of Bupleurum injection, with advantages of good repeatability, higher stability, and so on, and it can effectively monitor the quality of Bupleurum injection, to ensure stable and consistent Bupleurum injection clinical effect, and it has important application value.

Description

technical field [0001] The invention relates to a quality control method of Bupleurum injection, in particular to a method for controlling the quality of Bupleuri injection by using fingerprints. Background technique [0002] Bupleurum injection is an earlier developed traditional Chinese medicine injection. It has the effect of clearing away heat and relieving exterior. At present, the quality control method for Bupleurum injection is mainly to check the absorbance and pH value. Absorbance: accurately measure 5ml of injection, put it in a 50ml measuring bottle, add water to dilute to the mark, shake well, and use it as the test solution. In addition, accurately measure 5ml of injection solution, put it in an evaporating dish, evaporate to dryness on a water bath, add water to dissolve, transfer to a 50ml measuring bottle, add water to dilute to the mark, shake well, and use it as a blank. According to the spectrophotometric method (Appendix V A of "Drug Standards of the Mi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/00G01N33/15G01N30/86G01N30/60G01N30/08
Inventor 屠鹏飞鲍忠石子仪姜勇薛璟
Owner 北京华医神农医药科技有限公司
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