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Danhong injection quality control method
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A technology of Danhong injection and active ingredients, which is applied in the direction of measuring devices, material separation, and analysis of materials, to achieve good reproducibility, avoid one-sidedness, and high precision
Active Publication Date: 2014-01-08
ZHEJIANG UNIV +1
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When this method is used to evaluate the quantitative similarity of fingerprints, although the proportion of different components is considered, it is only in S F Significant effect at lower
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Embodiment 1
[0045] Example 1: Formulation of Danhong Injection Fingerprint
[0048] 1.2 Preparation of Danhong injection control sample solution
[0049] Precisely pipet 2 mL of Danhong injection, place it in a 10 mL measuring flask, dilute to the mark with acetonitrile-0.5% formic acid solution (50:50, v / v), shake well, and filter through a 0.45μm microporous filter membrane , That is.
[0050] 1.3 Liquid chromatography conditions
[0051] Chromatographic conditions: Agilent Zo...
Embodiment 2
[0068] According to the method of Example 1, the difference is that the correlation coefficient is calculated to evaluate the similarity of fingerprints.
[0069] Compare the fingerprints of 15 batches of Danhong injection products to be tested with the established standard fingerprints, calculate and identify the number of common peaks between the two, if the similarity is greater than 0.95, the injection is considered qualified, and the similarity is greater than 0.97, then the injection is considered injection The liquid batch is stable and the quality is better. It turns out that for similarity> Above 0.990, the similarity obtained by the correlation coefficient algorithm is very close to the cosine value of the included angle, but the similarity value calculated in the samples with lower similarity is significantly different. See Table 3.
[0070] table 3
[0071]
Embodiment 3
[0073] According to the method of Example 1, the difference lies in calculating the qualitative similarity of the ratio, that is, comparing the fingerprint Make sample Make Calculation versus The cosine of the angle between. If the similarity is greater than 0.95, the injection is considered qualified, and if the similarity is greater than 0.97, the injection batch is considered stable and the quality is better. The results are shown in Table 4.
[0074] Table 4
[0075]
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Abstract
The invention relates to a Danhong injection quality control method. According to the method, an efficient liquid chromatography is used for measuring fingerprint spectrums of Danhong injection products to be measured, and in addition, three kinds of algorithms including the included angle cosine algorithm, the relative coefficient algorithm and the ratio qualitative algorithm are adopted for calculating the qualitative similarity of fingerprint spectrums of the Danhong injection; and the P value and the M value are calculated, and the qualitative similarity of the fingerprint spectrums of the Danhong injection is obtained. Meanwhile, a content measuring method of eight effective ingredients of the Danhong injection is built. Finally, a high performance liquid chromatography (HPLC) is used for measuring, the conditions that the sodium danshensu and protocatechualdehyde content is greater than 350mug / mL, the qualitative similarity is greater than 0.95, the quantitative similarity P is between 0.80 and 1.20, and the M is between 0.90 and 1.10 are used as quality control standards for controlling the Danhong injection quality. The fingerprint spectrum qualitative and quantitative discrimination is combined with the multi-index quantitative analysis, and the reliability and the safety of the Danhong injection quality are further ensured.
Description
Technical field [0001] The invention relates to a method for controlling the quality of Danhong injection, a compound preparation of traditional Chinese medicines, in particular to control the quality of Danhong injection by using a fingerprint atlas combined with a method of high performance liquid chromatography (HPLC) multi-index component content determination. Background technique [0002] Danhong injection is a traditional Chinese medicine injection made from two medicinal materials of Danshen and safflower through extraction, concentration, alcohol precipitation, water precipitation, preparations and other processes. It is mainly used to treat angina, myocardial infarction, atherosclerosis and other cardiovascular and cerebrovascular diseases disease. It has the effects of quick onset and good curative effect, and has been widely used in clinical practice. However, due to factors such as uneven quality of raw medicinal materials and fluctuations in working conditions, pro...
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