Neuroprotective effects of Ginkgo biloba dropping pills in Parkinson's disease / 药物分析学报

Parkinson's disease(PD)is the second most common neurodegenerative disease in the world;however,it lacks effective and safe treatments.Ginkgo biloba dropping pill(GBDP),a unique Chinese G.biloba leaf extract preparation,exhibits antioxidant and neuroprotective effects and has a potential as an alternative therapy for PD.Thus,the aims of this study were to evaluate the effects of GBDP in in vitro and in vivo PD models and to compare the chemical constituents and pharmacological activities of GBDP and the G.biloba extract EGb 761.Using liquid chromatography tandem-mass spectrometry,46 GBDP constitu-ents were identified.Principal component analysis identified differences in the chemical profiles of GBDP and EGb 761.A quantitative analysis of 12 constituents showed that GBDP had higher levels of several flavonoids and terpene trilactones than EGb 761,whereas EGb 761 had higher levels of organic acids.Moreover,we found that GBDP prevented 6-hydroxydopamine-induced dopaminergic neuron loss in zebrafish and improved cognitive impairment and neuronal damage in methyl-4-phenyl-1,2,3,6-tetrahydropyridine-induced PD mice.Although similar effects were observed after EGb 761 treatment,the neuroprotective effects were greater after GBDP treatment on several endpoints.In addition,in vitro results suggested that the Akt/GSK3β pathway may be involved in the neuroprotective effects of GBDP.These findings demonstrated that GBDP have potential neuroprotective effects in the treatment of PD.

Analysis of adverse drug reaction/adverse event and early warning signal mining of Ginkgo biloba Dropping Pills based on SRS data / 中国中药杂志

In order to understand the characteristics of adverse drug reaction/adverse event(ADR/AE) of Ginkgo biloba Dropping Pills and evaluate the safety of clinical use after marketing, 407 ADR/AE case report data of Ginkgo biloba Dropping Pills collected by National Center for ADR Monitoring System during 2009-2018 was systematically analyzed, and its general characteristics were analyzed using descriptive statistical methods. The results showed that among the 407 cases of spontaneous reporting system(SRS) data, 401 cases were general ADR/AE, accounting for 98.5%, and 6 cases were severe ADR/AE, accounting for 1.5%; there were more females than males(171/150) in ADR/AE, and they were mainly middle-aged and elderly people aged 45-64 years(152 cases, accounting for 37.35%); gastrointestinal system(23.89%) was mostly involved in ADR/AE. The top ten clinical symptoms were nausea(15.49%), dizziness(9.88%), vomiting(8.11%), rash(5.60%), chest tightness(5.46%), palpitations(5.31%), pruritus(4.72%), headache(4.57%), abdominal distension(3.83%), gastric dysfunction(3.54%); proportional reporting ratio(PRR) and Bayesian confidence progressive neural network method(BCPNN) were adopted to mine ADR/AE warning signals. Due to the small sample size, there were only 0-2 ADR/AE cases with various symptoms in many quarters, with no warning signal by PRR and BCPNN methods. The findings suggest that ADR/AE of Ginkgo biloba Dropping Pills based on SRS system was not recorded in the package insert, and further active monitoring studies shall be conducted to improve relevant ADR/AE information and pay attention to its clinical drug safety issues.

Optimize dropping process of Ginkgo biloba dropping pills by using design space approach / 中国中药杂志

In this paper, a design space approach was applied to optimize the dropping process of Ginkgo biloba dropping pills. Firstly, potential critical process parameters and potential process critical quality attributes were determined through literature research and pre-experiments. Secondly, experiments were carried out according to Box-Behnken design. Then the critical process parameters and critical quality attributes were determined based on the experimental results. Thirdly, second-order polynomial models were used to describe the quantitative relationships between critical process parameters and critical quality attributes. Finally, a probability-based design space was calculated and verified. The verification results showed that efficient production of Ginkgo biloba dropping pills can be guaranteed by operating within the design space parameters. The recommended operation ranges for the critical dropping process parameters of Ginkgo biloba dropping pills were as follows: dropping distance of 5.5-6.7 cm, and dropping speed of 59-60 drops per minute, providing a reference for industrial production of Ginkgo biloba dropping pills.