Study On The Quality Standard Of Dandelion Preparation For Vagina And Its Clinical Effect On Primary Dysmenorrhea

Objective:1. To prepare a new and high concentration external preparation-vaginal dandelion preparation,and study its quality standard.2.To study the effect of different sterilization methods on the effective components of vaginal dandelion.3.To study the clinical effect of dandelion preparation for vagina on primary dysmenorrhea?PD?,so as to provide ideas and reference for further clinical treatment research.Methods:1. Prepare vaginal dandelion preparation according to the preparation process.Check the appearance,loading capacity,microbial limit and p H value of the preparation in accordance with the relevant provisions of the general principles of the Pharmacopoeia.The contents of total flavonoids,total phenolic acids and total polysaccharides were determined by UV spectrophotometry.The contents of chlorogenic acid,caffeic acid,ferulic acid,chicory acid,quercetin and luteolin were determined by ultra high performance liquid chromatography.The stability of the preparation was investigated by room temperature test.2. To determine the content of the effective components of vaginal dandelion preparation under three different sterilization methods.3.From June 2018 to September 2019,60 patients with PD who met the inclusion criteria were selected and divided into treatment group and control group.The treatment group used self-made dandelion extract,and the control group took ibuprofen capsule,all of which were treated for 3 menstrual cycles.The visual analog scale?VAS?score,dysmenorrhea symptom score,menstrual color,menstrual volume,menstrual quality and menstrual cycle change score of the two groups were recorded before and after treatment,and analyzed and compared.Results:1.The results of appearance character,loading capacity,microbial limit and p H value of vaginal dandelion preparation meet the requirements of Pharmacopoeia.According to the calculation of the maximum 20%loss in production and storage,the content of total flavonoids,total phenolic acid,total polysaccharide,chlorogenic acid,caffeic acid,ferulic acid,chicory acid and quercetin in each 1g preparation shall not be less than 16.10mg,3.56mg,119.33mg,0.3514mg,0.5478mg,0.0388mg,1.1212mg,1.1212mg and0.0388mg respectively 0.0642mg,luteolin content is not less than 0.1546mg.The results of methodology investigation are all in accordance with the requirements.The product was stored at room temperature for 6 months,and its properties,p H value and content met the requirements.2. Compared with the other two sterilization methods,the content of active components in ⁶⁰Co irradiation sterilization was higher?P<0.05?.3. There were significant differences in VAS score,CMSS frequency score,CMSS degree score,menstrual volume,menstrual quality,menstrual color and menstrual cycle change before and after treatment in the treatment group?P<0.05?.There were significant differences in VAS score,CMSS frequency score and CMSS degree score before and after treatment in the control group?P<0.05?.There were significant differences between the treatment group and the control group?P<0.05?.There was no significant difference in the effective rate between the two groups?P>0.05?.Conclusions:1.The study on the properties,examination and content determination of dandelion preparation for vagina was carried out.The method is simple,accurate and reliable.It can be used for the quality control of vaginal dandelion preparation.2.Irradiation sterilization has the least influence on the content of effective components of dandelion preparation for vagina,and it is selected as the sterilization method.3. Dandelion extract in the treatment of primary dysmenorrhea can shorten the pain time and reduce the degree of pain.Its initial clinical effect is significant,but its exact clinical effect in the treatment of primary dysmenorrhea needs further research.