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Objective:To observe the clinical efficacy of Shenxie Zhitong capsule in the treatment of diabetic peripheral neuropathy（DPN） of stagnant blockade of collaterals， and evaluate its effectiveness and safety. Method:The 104 patients were randomly divided into the Shenxie Zhitong capsule treatment group （the treatment group， 53 patients） and the alpha lipoic acid group （control group， 51 patients）， and two groups were compared by random and contrast test. The changes of the Toronto clinical scoring system （TCSS）， utah early neuropathy scores （UENS）， traditional Chinese medicine（TCM）syndrome scores， visual analysis scale （VAS）， ankle brachial index （ABI）， vibrating perception threshold （VPT） before and after treatment were compared between two groups， and the endpoint events， such as foot ulcers， percutaneous coronary intervention （PCI）， death and composite endpoint events， related indicators of glucose and lipid metabolism and safety indicators were recorded among patients. Result:Compared with the data before treatment， the scores of TCSS， UENS， and TCM syndromes in two groups were significantly reduced （<italic>P</italic><0.01） after treatment， and VAS and glycosylated haemoglobin A1c （HbA1c） were significantly reduced （<italic>P</italic><0.05）， during follow-up visit， the levels of right ABI，total cholesterol （TC）， and low-density lipoprotein （LDL） in two groups were significantly reduced （<italic>P</italic><0.05）， and high-density lipoprotein （HDL） level was significantly increased （<italic>P</italic><0.05）. control group in control group， the 2-hour postprandial plasma glucose （2 h PG） and HbA1c levels were significantly increased （<italic>P</italic><0.05）. Compared with control group， the VAS of the treatment group after treatment was significantly reduced （<italic>P</italic><0.05）. After treatment and during follow-up visit， compared with control group， the 2 h PG levels of the right toe in the treatment group were significantly reduced （<italic>P</italic><0.05）. There was no statistically significant difference in endpoint events and safety indicators between two groups， but the incidence trend of composite endpoint events in the treatment group was lower than that in control group. Conclusion:Shenxie Zhitong capsule has definite clinical curative effect in treating diabetic peripheral neuropathy， which is more safe and effective than alpha lipoic acid in improving pain symptoms.
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Objective: To rapidly analyze the chemical constituents of Huoxue Zhitong Capsules performed by ultra-high performance liquid chromatography quadrupole-time-of-flight mass spectrometry (UPLC-Q-TOF/MS). Methods: A Waters Acquity UPLC BEH C18 column (100 mm × 2.1 mm, 1.7 μm) was used with 0.1% formic acid aqueous solution and 0.1% formic acid acetonitrile as a mobile phase. The flow rate was 0.4 mL/min; The samples were collected in positive and negative ion modes, respectively. The processed data was analyzed by Masslynx 4.1TM software. Results: A total of 113 compounds were identified in positive and negative ion mode, including terpenoids, saponins, organic acids, benzoquinones and others, and the medicinal sources of the compounds were assigned. Conclusion: The established method can systematically, quickly and accurately identify various chemical components of Huoxue Zhitong Capsule. This study provides a reference for the selection of quality evaluation indicators and the basis of pharmacodynamics of Huoxue Zhitong Capsule.
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OBJECTIVE： To study the improvement effect and mechanism of Chuanju zhitong capsules （CZC） on migraine model rats. METHODS： SD rats were randomly divided into normal group， model group， chemical drug positive control group （Zolmitriptan tablet， 0.004 05 g/kg）， TCM positive control group （Compound yangjiao capsule， 4.32 g/kg）， CZC high-dose， medium-dose and low-dose groups （1.6， 0.8， 0.4 g/kg）， 10 rats in each group. All rats were relevant medicine intragastrically once a day， for successive 5 days. 30 min after last medication， except for normal group， rats in other groups were given glyceryl trinitrate subcutaneously （10 mg/kg） via head and neck to induce migraine model. The behavior changes of rats were evaluated using the times of scratching head as indexes within 2 h after modeling （30 min as a period of time）. 4 h after modeling， hemorheological parameters as whole blood viscosity （low-shearing， medium-shearing， high-shearing）， plasma viscosity， erythrocyte aggregation indexes and erythrocyte rigidity indexes were determined by automatic hemorheology instrument. The levels of NO， NOS， ET-1， CGRP in serum and the levels of 5-HT， 5-HIAA， DA and NE in cerebral tissue were determined by ELISA. RESULTS： Compared with normal group， the times of scratching head was increased significantly in model group at different periods （P＜0.01）. The serum levels of NO， NOS and CGRP were increased significantly （P＜0.01）， while ET-1 level was decreased significantly （P＜0.01）. The levels of 5-HT， DA and NE in cerebral tissue were decreased significantly （P＜0.01）， while 5-HIAA level was increased significantly （P＜0.01）. Whole blood viscosity （low-shearing）， plasma viscosity， erythrocyte aggregation index and erythrocyte rigidity indexes were increased significantly （P＜0.05），plasma viscosity were decreased significantly （P＜0.05） . Compared with model group， the times of scratching head were decreased significantly in TCM positive control group （0-120 min）， TCM positive control group （60-90 min）， CZC high-dose （30-120 min） and medium-dose （60-90 min） groups （P＜0.05 or P＜0.01）. The whole blood viscosity （low-shearing） and erythrocyte aggregation indexes of TCM positive control group， CZC high-dose and medium-dose groups were decreased significantly （P＜0.05 or P＜0.01）； the serum levels of NO， NOS and CGRP in chemical drug positive control group and CZC high-dose and medium-dose groups were decreased significantly （P＜0.05 or P＜0.01）， while the serum level of ET-1 was increased significantly （P＜0.01）； the levels of 5-HT， DA and NE were increased significantly in cerebral tissue （P＜0.05 or P＜0.01）， while the level of 5-HIAA was decreased significantly （P＜0.05）. CONCLUSIONS： The improvement effect of CZC on migraine model rats is associated with decreasing the serum levels of NO， NOS and CGRP and increasing the levels of 5-HT， DA and NE in cerebral tissue.
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OBJECTIVE:To observe the clinical efficacy and safety of Feijin zhitong capsule combined with methotrexate and tripterygium glycosides in the treatment of rheumatoid arthritis. METHODS:70 patients with rheumatoid arthritis were randomly di-vided into control group(34 cases)and observation group(36 cases). Control group received Methotrexate for injection by intrave-nous infusion,10 mg every times,once a week;and also Tripterygium glycosides tablet,10 mg every times,bid,po. Observa-tion group additionally received Feijin zhitong capsule,3 capsules every times,bid,po. The treatment course for both groups was 6 months. The clinical efficacy,symptoms and signs,erythrocyte sedimentation rate (ESR),rheumatoid factor (RF),C-reactive protein(CRP),interleukin(IL)-1,IL-6,IL-8 and TNF-α levels before and after treatment in 2 groups were observed,and the in-cidence of adverse reactions was recorded. RESULTS:The effective rate in observation group was 85.71%,which was significant-ly higher than control group(70.59%),the difference was statistically significant(P0.05). CONCLU-SIONS:Feijin zhitong capsule combined with methotrexate and tripterygium glycosides has good efficacy and safety in the treat-ment of rheumatoid arthritis,it can reduce the inflammatory index level,improve symptom and sign.
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Objective To determine the content of heavy metals and harmful elements in commercially available Yuanhu Zhitong Capsule. Methods The determination of lead, cadmium, arsenic, mercury, copper and chromium by atomic absorption spectrometry and atomic fluorescence spectrometry was established.Results The recovery rate of the method was between 91.2% and 111.2%, and the precision of the experiment was less than 5%, and the range of each element was good.The stability and reproducibility of the method were good.Lead and cadmium and copper of Yuanhu zhitong capsule in different degree exceeded the standard, while the content of arsenic, mercury and chromium was in accordance with the requirements. Conclusion The method is simple and easy to operate, convenient and quick.The content of the current limit of Yuanhu zhitong capsule still need to establish the quality standard of lead and cadmium, arsenic, mercury, copper and chromium.In this paper, the establishment of the heavy metals and harmful elements determination method of Yuanhu zhitong capsule provide quality control and safety evaluation of reference.
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AIM:To stuudy the relationship of the constituents of Erxiang Zhitong Capsule(Rhizoma alpiniae officinarum,Rhizoma cyperi and Radix aucklandiae) and its pharmacodynamics.METHODS:The use of supercritical CO_2 fluid extraction as extraction for three herbs acted as experimental materials.The preparation composed of Rhizoma Alpiniae officinarum extract,Rhizoma Cyperi extract;Radix Aucklandiae extract(3∶3∶2) had obviously antiulcerative,antispasmodic and anti-inflammatory analgesic effects.CONCLUSION: From view of pharmacodynamics view,we gain ratio of components of Erxiang Zhitong Capsule better than that of classical prescription.
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AIM:To establish a HPLC method for determining contents of tetrahydropalmatine and pepper alkali in Zhitong Capsule(Rhizoma Corydalis,Fructus Piperis,Radix Paeoniae alba,etc.)to control its quality.METHODS:The samples were extracted in water by ultrasonic wave,and then extracted by aether to refine after being acidized by 1 mol/mL HCl.Following that the pH of water solution was adjusted to 9.0-10.0 by NH_3?H_2O,and then extracted by aether again.After that,the aether solution was collected to evaporation to dryness and metered by methanol.The sample solution was determined by high performance liquid chromatography on a Hypersil ODS 2 C_ 18 column(4.6 mm?250 mm,5 ?m)with mobile phase composed methanol-0.1% phosphoric acid water solution(the pH was adjusted to 6.0 by triethylamine)(55∶45).The flow rate was 1.0 mL/min,the column temperature was at 30 ℃ and the signal from 0 to 14.5 minutes were acquired at 280 nm,and that from 14.5 to 22 minutes were detected at 328 nm.RESULTS:The resolution of tetrahydropalmatine and pepper alkali was good,with no miscellaneous peak.The linear range was at 0.196-1.96 ?g(r=0.999 6)for tetrahydropalmatine,0.03-0.3 ?g(r=0.999 7)for pepper alkali.The average rate of recovery of tetrahydropalmatine was 97.74%(RSD= 0.42%,n=6),and that of pepper alkali was 104.51%(RSD=2.01%,n=6).CONCLUSION:The method is simple,reliable,accurate and can be applied to the quality control of the preparation.