Method for quality control of injections for treating thromboangitis diseases
A quality control method and thrombus occlusion technology, applied in the field of medicine, can solve the problems of insufficient product quality control and other problems
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experiment example 1
[0043] Experimental Example 1: Methodological Research on Fingerprints
[0044] Stability test: Take the same part of the test solution and detect it at different times to investigate the consistency of the chromatographic peak retention time and peak area ratio. The results are shown in Table 1 and Table 2. internal stability.
[0045] peak number
[0046] peak number
[0047] Precision test: take the same test solution, inject 6 times continuously, and investigate the consistency of relative retention time and peak area ratio of chromatographic peaks. The results are shown in Table 3 and Table 4. It is stipulated that for each chromatographic peak with a common peak area ratio, the relative standard deviation of the peak area ratio is less than 3%.
[0048] peak number
[0049]
[0050] Reproducibility experiment: Take the injection of the same batch number, prepare 6 copies of the test product in parallel, and test them. The result...
experiment example 2
[0053] Experimental Example 2: Research on Fingerprint and Various Technical Parameters
[0054] Fingerprint: Figure 1 is the fingerprint and various technical parameters of Mailuoning Injection, Figure 2 is the blank baseline spectrum, Figure 3 is the reference spectrum, and Figure 4 is the fingerprint of Mailuoning Injection recorded for 2 hours.
[0055] Calibration of common peaks: According to the detection results of 10 batches of test samples, 10 chromatographic peaks common to each batch of samples with relatively stable retention time and peak area were selected as the common peaks of the fingerprint of Mailuoning injection. The sum accounts for more than 95% of the peak area. After HPLC / MS analysis, the four peaks were preliminarily determined to be 5-hydroxymethylfurfural (peak No. 1), chlorogenic acid (peak No. 3), caffeic acid (peak No. 4), and cinnamic acid (peak No. 10). .
[0056] The ratio of the common peak area: the relative retention time detection result...
experiment example 3
[0061] Experimental Example 3: Correlation Study of Fingerprints of Injections, Intermediates and Chinese Medicinal Materials
[0062] Using HPLC / DAD / MS technology, we investigated the correlation between Mailuoning Injection, intermediates and medicinal materials. The results showed that Mailuoning Injection had a good correlation with its intermediates, while Dendrobium , Scrophulariaceae and honeysuckle four medicinal materials are reflected in the injection and intermediates, the results are shown in Table 10.
[0063] t R (min)
[0064] According to the injection preparation process, injections containing only single medicinal materials were extracted and prepared. Measure 1.0ml of the single medicinal material injections into 10ml measuring bottles, add water to dilute to the mark, shake well, and use a 0.45um microporous filter membrane Filtration, as the test solution.
[0065] A%(V / V)
[0066] The detection wavelength is 300nm for the fingerpr...
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