Pharmaceutical Research Of Shaofu Zhuyu Gel Plaster

Shaofu Zhuyu Gel Plaster is made up of Angelica sinensis(Oliv.)Diels,Ligusticum chuanxiong Hort,Paeonia lactiflora Pall and 6 other herbal ingredients.It has the following functions:to promote blood circulation,remove blood stasis,dispel cold by warming the meridians and reduce swelling and relieve pain.For the treatment of blood stasis and less abdomen,dysmenorrhea,irregular menstruation and so on.This product is originally taken with decoction,but the decoction for the treatment of dysmenorrhea has poor targeting,slow onset,and inconvenient use,resulting in poor patient compliance.In this experiment,the decoction is changed into a gel paste,which can be directly attached to the guanyuan acupoint of abdomen to facilitate the patient’s medication.The active ingredients in the prescription can reach the lesion sites directly,which not only reflects the principle of "external aid to treat internal diseases" but also combine with acupoint and meridian theory.Based on the theory of traditional Chinese medicine,this study applies modern pharmaceutical methods and techniques to carry out research on extraction process,formulation molding process,and preliminary quality standards.According to the medicinal chemical composition and modern pharmacological research,the mouse hot plate analgesia experiment and the mouse primary dysmenorrhea model are used to screen the extraction process route to determine the volatile oil and alcohol extraction process.After single factor investigation,the parameters of the volatile oil extraction process are as follows: Angelica sinensis(Oliv.)Diels,Ligusticum chuanxiong Hort and other 4 volatile oils were added to 10 times of water,soaked for 2h,distilled by steam for 6h,and the volatile oil,dregs and extract are collected separately.It uses orthogonal design to investigate the process parameters such as extraction times,extraction time and ethanol dosage,while total content of paeoniflorin,ferulic acid,typhaneoside,isorhamnetin-3-O-neohesperidin,and the ratio of extraction as an evaluation index.The parameters of the prescription extraction process are as follows: the remaining medicinal materials and the dregs are added with 6 times 70% ethanol,and extracted 3 times,each time 1h,the extract recovers the ethanol to an alcohol-free taste,collecting all medicinal liquids and concentrated to a relative density.Finally,add the volatile oil and stir to obtain thetotal extract.In the research of formulation molding process,the matrix prescription is selected and optimized by using the Plackett-Burman design combined with the Box-Behnken effect surface method,and the optimal prescription ratio is as follows:NP-700-carbomer-kaolin-aluminiumglycinate-glycerin-tartaricacid(2.42:0.22:0.96:0.2:14:0.16).3% of the azone is screened as a penetration enhancer by a transdermal experiment.The final preparation process of this product is: to weigh the prescribed amount of carbomer,adding water to make it fully swell as phase A,NP-700,kaolin,aluminium glycinate with proper amount of glycerin dispersed uniformly as phase B,tartaric acid dissolved in water as phase C,Slowly add phase A to phase B,stir evenly,add phase C,traditional Chinese medicine extract,stir until uniform,and then immediately apply it to the non-woven fabric and to dry.In the research of quality standards,the TLC identification methods of Ligusticum chuanxiong Hort,Paeonia lactiflora Pall,Zingiber officinale Rosc and Corydalis yanhusuo W.T.Wang are established.A study on the determination methods of paeoniflorin,ferulic acid,isorhamnetin-3-O-neohesperidin and typhaneoside is carried out,and some inspections are carried out in accordance with the relevant regulations of the 2015 edition of the Chinese Pharmacopoeia.