| Objectives Cuscuta chinensis formula granule is a new type of Chinese medicine granule made from traditional Chinese herbal Cuscuta chinensis as raw material.The product is prepared by water issolution,solid-liquid separation,concentration,drying,molding,and other processes.At present,there are many studies on Cuscuta chinensis,but there are few studies on the formula granule of them.Through a series of qualitative and quantitative analysis of flavonoids in Cuscuta chinensis formula granule,we can fully understand the content of effective ingredients in them.It plays an important role in the quality uniformity and consistency of Cuscuta chinensis formula granules and the quality control level of manufacturers.Method:(1)With reference to the TLC Identification Method in the ChP.2015,the 12 batches of Cuscuta chinensis formula granules were identified by TLC,which used hyperoside and Cuscuta chinensis control medicine as reference materials.(2)The content of total flavonoids in the Cuscuta chinensis formula granule is based on the color reaction of flavonoids,and the absorbance at 5l0nm was read with rutin as the reference.Finally,the content of 12 batches of samples was calculated by standard curve.(3)The contents of hyperoside,isoquercitrin,quercetin and kaempferol in 12 batches of samples were determined by HPLC,which used acetonitrile and 0.1%(v/v)phosphoric acid as mobile phase for gradient elution and 360nm as detection wavelength/4)The fingerprint of Cuscuta chinensis formula granules was established by HPLC.And the quality control level of different manufacturers was analyzed by principal components analysis(PCA).(5)The contents of total flavonoids,hyperoside,isoquercitrin,quercetion and kaempferol are correlated with the near infrared by direct measurement of Cuscuta chinensis formula granules with partial least square(PLS)models.The quantitative analysis models of the above five components were established and the models were also validated.Result:(l)TLC identification results showed that the spots on the sample are the same as those on the standard.(2)The content of total flavonoids in 12 batches of samples ranged from 23 mg/g to 34 mg/g,and there was no significant difference among different batches of samples from different manufacturers or the same manufacturer.(3)The contents of hyperoside,isoquercetin,quercetin and kaempferin in 12 batches of samples ranged from 1.7 to 4.6 mg/g,0.34 to 0.84 mg/g,0.05 to 0.27 mg/g and 0.06 to 0.49 mg/g respectively.There are great differences between different manufacturers or different batches of the same manufacturer.(4)There are 19 common peaks were selected as the specific chromatograms with hyperoside as the reference peak,and 4 of them were identified.It was subsequently compared with the chromatograms from 12 batches of samples to generate the similarity values which were all above 0.900,except for the sample with a lot number of 7085862,which was 0.893.However,principal components analysis(PCA)demonstrated that different manufacturers had different quality control levels for samples.The samples produced by factory B and factory C has less fluctuation in quality,while the quality of samples produced by factory A and factory D was quite different.(5)Quantitative analysis model of total flavonoids is ideal.The quantitative analysis model of hyperoside and isoquerectrin can be basically used to predict their respective content values,but the performance of quantitative analysis models of quercetin and kaempferol needed to be further explored.Conclustion:Through the above five test methods,the flavonoids in 12 batches of Cuscuta chinensis formula granules from 4 factories were analyzed comprehensively.From the results,we can see that the chemical composition of Cuscuta chinensis formula granules produced by different manufacturers is similar and consistent,but the content of the ingredients is different obviously.It can be seen that there are great differences in the control of production quality between different manufacturers. |
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