ABSTRACT
Ginkgo biloba Extract( GBE50) Dispersible Tablets is a new standardized prescription,which is widely used in the treatment of ischemic cardiovascular and cerebrovascular diseases. However,there are still many problems in its clinical application.Rational and safe use of GBE50 Dispersible Tablets is pivotal to the medication safety and clinical prognosis of patients. This consensus has been jointly formulated by clinical experts of traditional Chinese medicine and western medicine in cardiovascular and cerebrovascular diseases and followed the Manual for the Clinical Experts Consensus of Chinese Patent Medicine published by the China Association of Chinese Medicine. The present study identified clinical problems based on clinical investigation,searched the research papers according to PICO clinical problems,carried out evidence evaluation,classification,and recommendation by GRADE system,and reached the expert consensus with nominal group technique. The consensus combines evidence with expert experience. Sufficient evidence of clinical problems corresponds to " recommendations",while insufficient evidence to " suggestions". Safety issues of GBE50 Dispersible Tablets,such as indications,usage and dosage,and medication for special populations,are defined to improve clinical efficacy,promote rational medication,and reduce drug risks. This consensus needs to be revised based on emerging clinical issues and evidencebased updates in practical applications in the future.
Subject(s)
Humans , Cerebrovascular Disorders/drug therapy , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , TabletsABSTRACT
The present study aimed to systematically evaluate the efficacy and safety of Ginkgo biloba extract 50(GBE50) in the treatment of ischemic stroke. The databases including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library were searched for randomized controlled trial(RCT) of GBE50 for the treatment of ischemic stroke reported between database inception and May 2020. The methodological quality of the included RCTs was evaluated via the Cochrane risk of bias tool. The RevMan 5.4 was used for Meta-analysis. Sixteen RCTs were included, involving 1 615 patients with acute ischemic stroke. Most of the included RCTs reported the methods of random sequence generation, but only two performed the concealment of random sequence. All RCTs failed in blinding. Two RCTs reported the information of cases lost to follow-up and drop-outs. Since the number was small, the baselines of groups remained balanced. All RCTs reported key outcomes of ischemic stroke, which made selective reporting bias in a low risk. Meta-analysis results revealed that GBE50 combined with routine therapies could effectively lower the score of the National Institutes of Health stroke scale(NIHSS) and restore cognitive function and daily activity in ischemic stroke patients. Compared with routine therapies, the combination is advantageous in treating patients with ischemic stroke. However, high-quality multicenter RCTs with large sample sizes are still required for verification.
Subject(s)
Humans , Brain Ischemia/drug therapy , Ginkgo biloba , Ischemic Stroke , Multicenter Studies as Topic , Plant Extracts , Stroke/drug therapyABSTRACT
In this study, the anti-inflammatory mechanism of Ginkgo biloba extract 50 (GBE50) and its mechanism of action on NLRP3 inflammatory corpuscles were observed by primary microglia cells. LPS/ATP was used to stimulate microglia, and the best time for stimulation and optimal concentration of GBE50 were screened. Pro-inflammatory cytokine IL-1 and TNF-α was determined by ELISA. Western blot was performed to observe the protein expression of NLRP3, ASC, caspase-1 and IL-1 in cultured primary rat microglia. Effect of GBE50 on NLRP3 inflammatory corpuscle aggregation was detected by CO-IP. GBE50 (10 mg·L⁻¹) preconditioning could significantly inhibit the expression of LPS (100 μg·L⁻¹,12 h), ATP (5 mmol·L⁻¹, 30 min) induced primary microglia corpuscle associated protein, inflammatory corpuscle aggregation, and the release of inflammatory factors IL-6 and TNF-α. These results indicated that GBE50 could inhibit the secretion of inflammatory factors after microglia activation, which is related to down regulating the protein expression and activity of NLRP3 inflammatory corpuscle.
ABSTRACT
Objective To evaluate the efficiency of Ginkgo biloba extract 50 (GBE50) on learning memory ability and inflammatory response in hippocampus of natural aging mice, and explore the underlying anti-aging mechanisms.Methods 16-month-old ICR mice were randomly divided into three groups:model group, GBE50 low and high dose groups. 1 month mice were as normal group. The mice in GBE50 low and high dose groups received GBE50. The mice in the normal and model groups received solvent (1%CMC-Na+) by intragastric administration. The Morris water maze test and step-down test were used to assess behaviors of the mice. Immunofluorescent staining was used to detect the number of Iba-1 positive cells. The enzyme linked immunosorbent assay was used to determine the expression of TNF-α and IL-1β.Results Compared with normal group, escape latency and swimming distance in the Morris water maze test in the model group increased (P<0.05);latency shorted and error times decreased in the step-down test (P<0.05);the number of Iba-1 positive cell in the hippocampus CA1 in the model group increased considerably (P<0.01);TNF-α expression was in a general upward trend while IL-1β increased apparently (P<0.01). Compared with model group, escape latency and swimming distance decreased in the Morris water maze test in GBE50 high dose group;latency and the error times increased in the step-down test (P<0.05);the number of Iba-1 positive cells decreased (P<0.05). TNF-α expression showed a downward trend and IL-1β expression decreased in GBE50 low dose group (P<0.05). Conclusion GBE50 can delay aging and increase learning memory of natural aging mice.
ABSTRACT
Objective: To optimize the preparation of Ginkgo biloba extract-β-cyclodextrin inclusion (GBE50-β-CD inclusion) complex by central composite design and response surface methodology. Methods: Saturated aqueous solution method was used to prepare GBE50-β-CD inclusion complex. The preparation was optimized by central composite design. With the mass ratio of β-CD/GBE50, inclusion time and temperature as the independent variables and with the inclusion rate as the dependent variable, the binomial and linear equations were fitted to the data of overall desirabilities, and the resulting equation was used to produce 3-D response surface graphs, through which optimal formulation was predicted, the best prescription process was chosen to verification test. Results: It showed that the correlation coefficient of second-order quadratic model was higher and the prediction was better (r = 0.966); The optimum conditions for the preparation of GBE50-β-CD inclusion complex were as follows: the mass ratio of β-CD/GBE50 3:1, inclusion time 6 h, inclusion temperature at 60 °C. The deviation between, the result of the best craft verification test and the binomial fitting equation forecast value is 1.07%. Conclusion: Central composite design and response surface methodology is successfully used to optimize the preparation of GBE50-β-CD inclusion complex. The optimized process is reliable, stable, and available for the industrial production.