| Objective:This paper is based on "Liuwei Dihuang",developing a function food for young and middle-aged women,named Mengying oral liquid,which is using ziziphispinosaesemen,Rehmannia glutinosa and corni fructus as the main raw materials in Shanxi Province.It has the function of nourishing blood,nourishing liver and calming heart.In this paper,the prescription research,extraction and preparation technology,functional evaluation,safety evaluation and quality standard of Mengying oral liquid were systematically studied to provide experimental basis for the further development and application of Mengying oral liquid.Methods : Through literature review,the main active components,modern pharmacological action and efficacy of the prescription were analyzed,and the significance of prescription compatibility was demonstrated.Pentobarbital sodium was used to induce sleep in mice to verify the function of the prescription to improve sleep and optimize its compatibility dose.In addition,the network pharmacology technology was used to predict and screen the targets of Mengying oral liquid to improve sleep,establish the network correlation relationship,explore its possible mechanism of action,and further explain the prescription compatibility rule of Mengying oral liquid.After the purification,impurity removal,washing and soaking of the raw materials in the prescription,the method of water extraction and alcohol precipitation was adopted.The total saponin content was taken as the index to investigate the technological parameters such as decoction time,amount of water added and number of decoctions.And the test was designed to The alcohol precipitation process was further determined with the total saponin content as the evaluation index.Finally,based on the taste as the basis of evaluation,through the evaluation personnel taste score to obtain the best preparation of Mengying oral liquid molding process.Three doses of Mengying oral liquid(2.3,4.6,9.3 g crude drugs/kg)were administered orally to ICR mice for 30 consecutive days.Sodium pentobarbital sleeping time of test,pentobarbital sodium sleep latency test and subthreshold dose of sodium pentobarbital sleep test were uesd to detect behavioural indicators,such as sleep time,sleep latency period to evaluate the function of Mengying oral liquid to improve sleep on mice。According to the characteristics of Mengying oral liquid,the safety of Mengying oral liquid was evaluated.First,Mengying oral liquid was administered to mice and SD rats twice a day with the maximum dose and the maximum gavage of 20 mL/kg BW.Then,three doses of Mengying oral liquid(11.7,23.3,46.7g crude drugs /kg)were administered to SD rats for 30 consecutive days to observe the animal poisoning,and the hematology,blood biochemistry,viscera index and histopathological examination were conducted.The quality control of Mengying oral liquid was carried out,and the sensory indexes of Mengying oral liquid were established by means of sensory evaluation.With reference to the national standards,the physical and chemical indexes,microbial limits and pollutant limits of Mengying oral liquid were established.A method for the determination of total saponins in Mengying oral liquid was established by ultraviolet spectrophotometry.HPLC method was used to determine the content of Loganin,Verbascoside and spinosin in Mengying oral liquid.Results:Mengying oral liquid has the effect of nourishing blood,nourishing liver,calming the heart and the mind.The results of network pharmacology indicated that the active components of Mengying oral liquid mainly acted on the related proteins of the dopaminergic nervous system to regulate the downstream signaling pathway.In addition,the sterol components regulated the estrogen signaling pathway to improve the level of estrogen in the body,thus affecting the neurotransmitter conduction related to the regulation of sleep.The targets of alkaloids,flavonoids and terpenoids can be enriched in platelet activation,vascular smooth muscle contraction and other signaling pathways to improve hemorheology and blood microcirculation.Polysaccharides regulate inflammatory factors and improve immunity.Mengying oral liquid from multiple channels,multiple targets to regulate the balance of the body,play a role in improving sleep.The best preparation process for Mengying oral liquid : after purifying washing and soaking,raw material medicine were add 10 times the amount of water,boiling for 3 times,each time 1 hour decoction.After filtration and concentration,it was added the 70% ethanol and standed for 18 hours.Separating clear liquid and recycling of ethanol,adding 5% sugar,0.10% potassium sorbate,add water to the right amount.Finally,sterilization,filling,packing,inspection made it into finished products.The results of functional evaluation showed that Mengying oral liquid could cooperate with pentobarbital sodium to prolong the sleep time of mice,shorten the sleep latency and improve the sleep rate.The effect of pentobarbital sodium on prolonging sleep time was better than that of pentobarbital sodium on shortening sleep latency.The safety evaluation results showed that Mengying oral liquid had no obvious toxicity and teratogenics,and no obvious damage to liver,kidney,spleen,testis and ovary and other major organs.The non-toxic dose was 46.7g crude drug /kg,equivalent to 200 times of the clinical dose,indicating that Mengying oral liquid was safe and nontoxic.In the study of quality standard,the method of determining the content of total saponins of Mengying oral liquid was established by uv spectrophotometry,and the method of determining the content of Loganin,Verbascoside and spinosin in Mengying oral liquid was established by HPLC.According to the national standard(gb16740-2014),the draft quality standard of Mengying oral liquid was formulated,which can be effectively used in the quality control and product quality evaluation of Mengying oral liquid in the production process.Conclusion: Mengying oral liquid is a kind of health food that has the function of improving sleep.This paper,through literature search,data mining,network pharmacology,function evaluation,and other technical means comprehensive illustrates the rationality of prescription compatibility of Mengying oral liquid.The process parameters of water extraction and alcohol precipitation were determined,the function and safety of Mengying oral liquid were evaluated,and the quality standard was drawn up.It has basically completed the research and development of the Mengying oral liquid,which is worthy of further promotion and use. |