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A bioassay method for inhibiting platelet aggregation in vitro was established to quantify the pharmacological effects of Compound Danshen Tablets and support its quality control. The inhibition of platelet aggregation in rabbit plasma in vitro by Compound Danshen Tablets was used as the experimental system. The titer was calculated by using the method of dose-response parallel lines. As a result, a bioassay for the inhibition of platelet aggregation in vitro by Compound Danshen Tablets was established. Linearity was good in the concentration range of 0.128 g·mL-1 to 0.205 g·mL-1, and the titer of standard Compound Danshen tablets was 7 659 U·g-1 according to the titer definition. This in vitro assay was simple, reliable, reproducible and convenient. The activity of Compound Danshen Tablets in inhibiting platelet aggregation was quantified by potency assay and the quality of different batches was evaluated. The method can be applied for the quality control of Compound Danshen Tablets.
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To determine the contents of salvianolic acid B and borneol in compound Danshen tablet (composed of Salviae Miltiorrhizae Radix et Rhizome, Notoginseng Radix et Rhizome and Borneolum Syntheticum) by near-infrared spectroscopy (NIR) and to establish a dependency model for rapid quantitative analysis. NIR data of 74 batches of compound Danshen tablet from different companies were collected; the contents of salvianolic acid B and borneol were determined by using high performanceliquid chromatography (HPLC) and gas chromatography (GC) respectively to establish the dependency model for salvianolic acid B and borneol. The results showed that the best waveband for salvianolic acid B was 10 846.2-10 013, 9 195.3-8 362.2, 6 719.1-4 242.8 cm⁻¹; root-mean-squares error of cross-validation (RMSECV), coefficient of determination ² and regression point displacement (RPD) of salvianolic acid B were 1.72 mg·g⁻¹, 91.05% and 7.93 mg·g⁻¹, respectively. While the best wavebands, RMSECV, ² and RPD of borneol were 10 846.2-5 060.5 cm⁻¹, 1.2 mg·g⁻¹, 96.11% and 6.71 mg·g⁻¹，respectively. The relative error of the established model as validation results for validation set samples was 2.67% and 4.64%， respectively.With the good predictability, the models can be applied to the real time monitoring and quality control of compound Danshen tablet.
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Objective: To establish a quantitative analysis method of multi-components by single marker (QAMS) for the simultaneous determination of four tanshinones [tanshinone IIA (TIIA), dihydrotanshinone I (DTI), cryptotanshinone (CT), and tanshinone I (TI)], and to explore its accuracy and feasibility on quality evaluation of traditional chinese medicine preparations about three kinds of related preparations of Salvia miltiorrhiza. Methods: An HPLC method was used to calculate relative correction factors (fi/s) between other three components with TIIA. The component positioning methods were compared including retention time difference value, relative retention value, and linear regression methods. Meanwhile, the contents of tanshinones in different preparations of S. miltiorrhiza were determinated by the external standard method (ESM), including Danshen Tablet, Compound Danshen Tablet, and Guanxin Danshen Capsule. Measured content value was compared with calculated content value to evaluate the accuracy of QAMS method. Results: Within a certain range, the fi/s of DTI, TI, and CT to TIIA were 0.734, 0.916, and 0.774, respectively, with the good repeatability in different experimental conditions. The fi/s between other three components with TIIA was accurate and reliable, and there was no significant difference between QAMS and ESM method. Besides, the relative retention value method could be used to accurately locate the measuring component. The relative retention values of DTI, TI, and CT to TIIA were 0.314, 0.518, and 0.561, respectively. The contents of three kinds of S. miltiorrhiza preparations showed there were some differences in the intrinsic quality of the products from different factories, even from different batches of the same manufacturer. Conclusion: The QAMS method could be used for quality control about related preparations of S. miltiorrhiza and provide references for quality evaluation of other preparations. At the same time, the above three kinds of traditional Chinese medicine preparations should be further strengthened the control and supervision.
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OBJECTIVE:To observe clinical efficacy of recurrent oral ulceration with combination of Zhibai dihuang pills and Compound danshen tablets. METHODS:110 patients with recurrent oral ulceration were selected and divided into control group and tri-al group with 55 cases in each group. Control group individually received vitamin C 0.2 g/time+vitamin B2 10 mg/time+levamisole 45 mg/time,three times a day,Cetylpyridinium chloride collutory,15 ml/time,for 1 min,3 times a day. Trial group received Zhibai di-huang pills orally,8 pills/time,Compound danshen tablets,3 tablets/time,3 times a day. A treatment course lasted for 10 days. Both groups received 2 courses of treatment. Therapeutic efficacy,VAS and relapse were observed and compared between 2 groups. RE-SULTS:The cure rate(80.00%)and total effective rate(94.55%)of trial group were higher than those of control group(47.27%, 74.55%),with statistical significance(P<0.05). The VAS score of trial group were significantly lower than that of control group after 3 and 7 days of treatment,with statistical significance(P<0.05). After 2,6,10 and 12 months of treatment,the recurrence rates of tri-al group were 0,7.27%,9.09% and 16.36%,which were all significantly lower than those of control group(18.18%,34.55%, 47.27%,56.36%),with statistical significance(P<0.05). CONCLUSIONS:Combination of Zhibai dihuang pills and Compound danshen tablets has definite effect on recurrent oral ulcer,showing high cure rate and not easily recur.
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Compound Danshen aerosol remarkably increased hypoxia tolerance after isoproterenol injection and prolonged survival time in mice. The electrocardiogram of rats and rabbits with pituitrin-induced ischemia was significantly improved. The aerosol also decreased the elevation of lactic dehydrogenase in rats with experimental myocardial infarction.
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AIM:A new method to rapidly non-destructive quality control Compound Danshen Tablet was developed by portable acousto-optic tunable filter (AOTF)-near infrared (NIR) spectroscopy. METHODS:A portable AOTF-NIR spectrometer was used to test 215 different batches of Compound Danshen Tablet collected from fifty-six pharmaceutical factories. The samples were analyzed by the Unscrambler program using principal component analysis(PCA). Quantitative analytical models invoking the partial least squares (PLS) algorithm simultaneously predicted the contents of four major constituents in Compound Danshen Tablet:salvianolic acid B,tanshinoneⅡA,water extract and alcohol extract. RESULTS:The qualitative analysis models accurately identified the differences between Compound Danshen Tablet and other reference substances. The results of external validation showed by the significant t-test that no significant difference between predictive and the chemical value,RSD was equal to 0. 990 9,0. 991 3,0. 964 0 and 1. 73% ,2. 08% ,3. 32% ,1. 32% ,respectively. CONCLUSION:The method of rapid non-destructive analyzing Compound Danshen Tablet is explored.
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AIM:The method of HPLC was established for the analysis of fingerprint of Compound Danshen Tablet (Radix et Rhizoma Salvial miltiorrhizal,Radix et Rhizoma Notoginseng,Borneolum Syntheticum) and the determination of its main components. METHODS:The fingerprint chromatograms of liposoluble constituents of Compound Danshen Tablet were set up and its main components of 10 batches were determined. RESULTS:The fingerprint chromatograms were simulated with mean method and the analysis of different batches of Compound Danshen Tablet was made after the analysis of the fingerprint chromatograms from different groups of Compound Danshen Tablet. The similarities which were proved to be higher than 0.99 were calculated with the help of The Similarity Calculation Soft of Fingerprint Chromatography of Traditional Chinese Medicin. CONCLUSION:This method is accurate and provides a scientific basis for controlling the quality of Compound Danshen Tablet.
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AIM:To set up a determination of tanshinone Ⅱ_A and cryptotanshinone in Compound Danshen Tablet(Radix Salviae Miltiorrhizae, Radix Notoginseng, Borneolum Syntheticum) by RP-HPLC. METHODS:Two components could be separated through YWG-C_~18 column with methanol-water (75∶25 by volume) as a mobile phase. The flow rate was 1.0 mL?min~-1 , and the detection wavelength was at 270 nm. RESULTS: The linear range of tanshinone Ⅱ_A and cryptotanshinone were 2.5-50.0 ?g?mL~-1 and 0.625-12.5 ?g?mL~-1 , respectively. The average recovery was 99.76% with RSD 0.92% for tanshinone Ⅱ_A and 98.34% with RSD 0.71% for cryptotanshinone, respectively. CONCLUSION: The method is simple, accurate and rapid with good reproducibility. It can be used for the quality control of Compound Danshen Tablet.