ABSTRACT
Objective: To explore the placebo-preparation method of Ginkgo Folium Dropping Pills (GFDP) and evaluate its simulation effect objectively, which could provide production and evaluation reference for Chinese materia medica (CMM) placebo. Methods: Taking the placebo-preparation of GFDP as an example, the simulation effect was evaluated from aspects of appearance, color, smell, and taste. It employed three different approaches as possibility of experimental drug, similarity evaluation between placebo and experimental drug and the similarity analysis among the drugs. Results: The two placebo-preparation prescriptions of GFDP have high similarity with the original drug in terms of appearance, color, smell, and taste. The simulation effect of No. 2 placebo-prescription (0.6 g of sucrose octaacetate as bitter agent, 2.1 g of caramel as colorant, 13.3 g of PVP K30 as fillerz and 44.0 g of PEG 4000 as water-soluble bases to prepare 1 000 pills) is better than No. 1 placebo-prescription (1.2 g of sucrose octaacetate as bitter agent, 2.1 g of caramel as colorant, 12.7 g of PVP K30 as filler, and 44.0 g of PEG 4000 as water-soluble bases to prepare 1 000 pills). Conclusion: The placebo-preparation of GFDP conform to placebo requirements of randomized controlled trials. It fills the vacancy of dropping pills form placebo-preparation in CMM and provides method and idea for placebo-preparation and simulation-effect evaluation of CMM.
ABSTRACT
OBJECTIVE@#To investigate the effect and safety of Guanxinning Tablet (, GXN) for the treatment of stable angina pectoris patients with Xin (Heart)-blood stagnation syndrome (XBSS).@*METHODS@#One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN (80 cases) or placebo (80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets (0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test (treadmill protocol), Chinese medicine (CM) syndrome score, electrocardiogram (ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events (AEs) were evaluated during the whole clinical trial.@*RESULTS@#Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28 ±17.67 s after treatment (P>0.05); moreover, the change of exercise duration in the GXN group increased 63.10 ±96.96 s in subgroup analysis (P<0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group (40.58%, 75.36%, 26.92%, 28.21%, respectively, P<0.05).@*CONCLUSION@#GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.
ABSTRACT
Objective: To explore the correlation between the high expression of hepcidin and vascular endothelial damage and the intervention effect of tetramethylpyrazine (TMP). Methods: Twenty-four SD rats were randomly divided into four groups: blank control, model, heparin, and TMP groups. Except the rats in the blank control group, the rats in all other groups were fed with high-fat diet for 8 weeks. The rats in the blank control and model groups were injected with normal saline at 2 mL/(kg∙d). The rats in the TMP group were injected with TMP at 40 mg/(kg∙d), and heparin at 5 mg/(kg∙d) was given to those in the heparin treated group. After rats were given medicine for 7 d, the levels of blood lipid, serum hepcidin, NO, ET-1, ROS, MDA, CAT, and SOD were detected. Results: As compared with blank control group, the levels of hepcidin, ET-1, ROS, and MDA in serum were significantly increased in the model group (P < 0.05), while NO, CAT, and SOD were obviously decreased (P < 0.05). Compared with the model group, the levels of hepcidin, ET-1, ROS, and MDA in serum were obviously decreased in TMP and heparin groups (P < 0.05), while NO and CAT were obviously increased (P < 0.05). Conclusion: Hepcidin expression is increased with the vascular endothelial damage aggravated. After rats are given TMP, the level of serum hepcidin and extent of vascular endothelial damage are decreased. It is suggested that TMP has the protective effects on the vascular endothelial function might be correlated to inhibiting high expression of hepcidin.
ABSTRACT
Ginsenoside Rb3 (GRb3) is one of the main components in plasma of Panax quinquefolius Saponin of stem and leaf (PQS), which can be into human plasma. Previous studies have found PQS has estrogen-like vascular protective effects. In the present study, we investigated the estrogen-like protective effect of GRb3 on oxidative stress and dysfunction of endothelial cells induced by oxidized low-density lipoprotein. The activities of SOD, NOS and the contents of MDA in the cell lysate were examined by enzyme method or spectrophotometry. The NO and ET-1 concentrations in the cell culture supernatant were measured by ELISA method. The iNOS and eNOS mRNA expression were measured by real time RT-PCR, while the phosphorylation levels of Akt was measured by Western blotting. The results showed that GRb3 could enhance the activity of SOD, reduce the content of MDA, increase the level of NOS, NO, ET-1 and iNOS mRNA expression while decrease the eNOS mRNA expression and the phosphorylation level of Akt. These effects were blocked by estrogen receptor antagonist ICI182780. GRb3 can play a role in protecting vascular endothelial cells by estrogen receptors, the protective mechanism is similar to 17-β estrodiol.