Chronic heart failure(CHF), a serious and end stage of various heart diseases, is a common chronic cardiovascular disease in the 21 st century. Literature data show that the 5-year mortality rate of hospitalized patients with heart failure is as high as 50%. Nowadays, the development of drugs treating heart failure has become a hot spot, meanwhile, traditional Chinese medicine(TCM) has shown the advantages in the treatment of chronic heart failure. In this article, four stages to develop traditional Chinese medicine for chronic heart failure were proposed. Firstly, discuss and screen ideas and methods with regard to the development of TCM and its prescriptions based on clinical needs. Secondly, study the preparation process and quality control method by referring to the existing clinical background of TCM prescriptions and analyzing the chemical compositions and pharmacological action characteristics of each herb in the prescription. Then, design non-clinical evaluation programs and carry out researches on pharmacodynamics and toxicology by combining the experience of clinical use of TCM prescriptions and future clinical positioning, and gradually adjust and improve the programs during implementation. Finally, conduct clinical trial application(IND) by submitting registration application data which are base on the clinical drug experience, preclinical research pharmacy, main pharmacodynamics, safety test results of the prescription, clinical positioning, and reasonable clinical trial plan designed by the theory of TCM. After passing the IND technical review, the clinical trial study shall be officially launched to achieve the desired results and obtain effective Chinese patent medicines for heart failure treatment.
Chronic Disease ; Drugs, Chinese Herbal ; Heart Failure ; Humans ; Medicine, Chinese Traditional ; Quality Control

To evaluate the efficacy and safety of Choudongning (CDN)capsule in children with Tourette's syndrome of spleen deficiency and phlegm accumulation through a randomized double-blind three-arm controlled phase Ⅲ study in 588 patients from 8 hospitals. The included patients were randomly divided into test group, positive control group and placebo group at the ratio of 3∶1∶1. Patients in the test group orally took CDN capsules and simulated Tiapridal tablets; the patients in positive control group took Tiapridal tablets and simulated CDN capsules; whereas the patients in placebo group orally took the simulated agents of the above two drugs. The treatment course was 6 weeks for three groups. The global grading rates, YGTSS scores and its factor scores, the degree of social function damage, as well as traditional Chinese medicine syndrome efficacy were evaluated as the outcome measures on efficacy. The AEs/ADRs, vital signs and laboratory testing were observed as outcome measures on safety. The total effective rate of YGTSS was 75.92% in the test group, 72.65% in the positive control group, and 37.29% in the placebo group. Non inferiority test stands between the test group and the positive control group, and they were superior to placebo group in efficacy with statistical difference. Significant difference had also been found among the 3 groups in YGTSS tics score, motor tics score, vocal tics, degree of social function damage and traditional Chinese medicine syndrome efficacy. During the study, there were 5 (1.42%)ADRs in the test group, 10 (8.55%)in the positive control group and 3 (2.54%)in the placebo group. The incidence of ADRs in the test group was lower than that in the positive control group, with statistical difference. It is clear to say that CDN capsule can effectively treat the Tourette's syndrome of spleen deficiency and phlegm accumulation. Its efficacy is not inferior to the commonly used Tiapridal tablets, with even less adverse reactions, so it has clinical application value.

ObjectiveChemical components in ethanol extract of Cyclocarya paliurus dried leaves were analyzed by ultra-high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry （UHPLC-Q-TOF/MS）. MethodAn Agilent Poroshell 120 EC-C₁₈ column （3.0 mm×100 mm， 2.7 μm） was used with 0.1% formic acid aqueous solution （A）-acetonitrile （B） as the mobile phase for gradient elution （0-26 min，2%-18%B； 26-60 min， 18%-72%B； 60-70 min， 72%-100%B； 70-71 min， 100%-2%B； 71-72 min， 2%B）， and the flow rate of 0.4 mL·min^-1 and injection volume of 3 μL. The electrospray ionization （ESI） was used in positive and negative modes， and detection range was m/z 50-1 100. The collected data were processed by Agilent MassHunter workstation. According to the retention time and MS information of each compound， combined with existing literature and MS database information， the compounds were identified and analyzed for the fragmentation rule. ResultA total of 52， 55 components were identified in the positive and negative ion modes， respectively. Among them， 14 flavonoids， 3 triterpenoids， 15 organic acids and 20 other compounds were identified under positive ion mode， while 18 flavonoids， 9 triterpenoids， 18 organic acids and 10 other compounds were identified under the negative ion mode. By summarizing the positive and negative ion modes and removing the common compounds， 87 compounds were identified， including 22 flavonoids， 27 organic acids， 11 triterpenoids and 27 other compounds. ConclusionUHPLC-Q-TOF/MS can be used to quickly analyze the chemical constituents in C. paliurus dried leaves. 1-Kestose and 18β-glycyrrhetinic acid and other components related to hypoglycemic activity of this herb are identified for the first time， which can provide reference for clarifying the pharmacodynamic substance basis of C. paliurus dried leaves.