RÉSUMÉ
The quality control of Chinese patent medicines containing animal-derived crude drugs is relatively difficult, because the effective constituents of most animal-derived crude drugs remain unknown. Even if there are relevant methods, they are usually qualitative, and quantitative indicators are either lacking or have poor specificity. This paper has proposed to use molecular quantitative technology to control the quality of Chinese patent medicines containing animal-derived crude drugs. In this study, a molecular quantitative method based on fluorescence quantitative PCR was established for the determination of Jinqian Baihua She in Jinlong Capsule. The method has good specificity, sensitivity, and repeatability. There is a good linear relationship between the content of DNA fragments and the CT (cycle threshold) value. The content of the Bungarus multicinctus-specific fragment in Jinlong Capsule is 24.1-46.6 IU·mg-1. It is suggested that the content of the specific fragment of Jinqian Baihua She should not be less than 19.3 IU·mg-1 as one of the quality control criteria of Jinlong Capsule. The study can provide a reference for the quality control of Chinese patent medicines containing animal-derived crude drugs.
RÉSUMÉ
Objective To establish the fingerprint of amino acids composition of Jinlong capsule. Methods Using 6-acetamido-4-hydroxy-2-methyl quinoline (AQC) as the derivating agent, 17 kinds of amino acids were analyzed by UPLC at the same time and the fingerprint of amino acids composition of Jinlong capsule was established. Result Totally 22 co-possessing peaks were selected as the fingerprint peaks, 17 kinds of amino acids were identified. The fingerprint similarity value of 10 batches was above 0.9. Conclusion The fingerprint is characteristic and can be used for the quality control of Jinlong capsule.
RÉSUMÉ
Objective: This study aimed to investigate the effects and side effects of Jinlong Capsule with concurrent three-dimen-sional conformal radiotherapy for advanced primary hepatic carcinoma. Methods: A total of 85 patients with inoperable primary hepat-ic carcinoma were randomly divided into a research group and a control group. Forty-two cases in the control group were treated with three-dimensional conformal radiotherapy alone, whereas 45 cases in the research group were treated with three-dimensional conformal radiotherapy and Jinlong Capsule oral administration. All cases were irradiated with 6 MV X-rays, 2 Gy per day, 5 days a week to a to-tal dose of 60 Gy in 6 weeks. Jinlong Capsule (1 g) was administered orally three times daily until disease progression for at least one year. The short-term therapeutic effect and adverse events were evaluated for 2 months after treatment. The long-term therapeutic effect was assessed at the end of follow-up. Results: The objective response rate of the research group was significantly higher than that of the control group at 74.4% and 47.6%, respectively (P=0.011). The disease control rates were 97.7% and 85.3% (P=0.030) for the re-search and control groups, respectively. No obvious difference was found between the complete response rates of the two groups, 20.9% and 14.3% (P=0.422). The 1- and 3-year overall survival rates of the research group (74.4% and 34.9%) were significantly high-er than those of the control group (66.7% and 16.7%) at P=0.046. The 1- and 3-year progression free survival rates of the research group (74.4% and 27.9%) were significantly higher than those of the control group (61.9% and 9.5%) at P=0.038. The main adverse events were grade 1–2 bone marrow suppression, abdominal distension, nausea, vomiting, and transaminase elevation. No obvious dif-ference was observed between the adverse events in the two groups. Conclusion: The short- and long-term effects of the combination therapy of Jinlong Capsule and three-dimensional conformal radiotherapy on primary hepatocellular carcinoma were significantly high-er than those of three-dimensional conformal radiotherapy alone. The patients also tolerated the adverse effects.
RÉSUMÉ
Objective:To determine the effects of Jinlong capsule combined with interventional therapy on the immune functions of primary hepatocellular carcinoma patients. Methods:Sixty randomly selected cases of clinically diagnosed primary hepatocellular carcinoma were divided into the observation group and the control group. Three days after operation, the observation group was given four Jinlong capsules three times a day for 30 days (one treatment). Meanwhile, the control group received interventional therapy after the operation. One to four days following one treatment, peripheral blood specimens were collected from the two groups to determine the cellular immune function indices. Results:The cell numbers (mean) of the peripheral blood components CD3, CD4, NK, SIL-2R, TSGF, and SIL-2R and the CD4/CD8 ratio in the observation group showed no significant difference before and after treatment. In the control group, these indices were significantly different before and after treatment. Conclusion:The Jinlong capsule facilitates the cellu-lar immunity recovery of patients with primary hepatocellular carcinoma after interventional therapy.