Studies On The Preparation Technology And Quality Standard Of Huaiming Runchang Tablets

The incidence rate of constipation is a increasing problem concerned with the increasing aging population and social competition pressure.First,We here in sumed up the causes and harm of constipation,and Common clinical treatment.Based on the clinical medication experience,literature search results and TCM theory,it is determined that Huaiming Runchang tablet with the effect of moistening intestines and defecating is made of Sophora japonica L.,Ophiopogon japonicus(L.f)Ker-GawL,Arctium lappa L.,Cassia obtusifolia L.and Angelica sinensis(Oliv.)Diels.And,the preparation process ? quality standard and stability of the product were studied.The details of experiments as follows:1.Screening prescriptionThis study used CNKI to search the relevant literature with the title of "Runchang" and PubMed to search the literature with the title of "laxative" with the aim of selecting the best prescription for the treatment of constipation.The results showed that the Sophora japonica has the effect of Cooling blood,relieving heat and moistening dryness,the Angelica sinensis has the effect of nourishing blood,the Ophiopogon japonicus has the effect of promoting the secretion of saliva or body fluid,the Arctium lappa has the effect of Softening stool,and the Cassia obtusifolia has the effect of Clearing the bowels,promoting blood circulation and resolving phlegm.These results collectively demonstrate that the 5 herbs can treat constipation cooperatively.Therefore,the Huaiming Runchang Tablets is made of five kinds of medicinal and edible plants: Sophora japonica L.,Ophiopogon japonicus(L.f)Ker-GawL,Arctium lappa L.,Cassia obtusifolia L.and Angelica sinensis(Oliv.)Diels.2.Extraction processTo obtain the active components of each medicinal material as much as possible,water decoction extraction process was adopted.Decoction times,the amount of water added and length of decoction were three main factors affect the extraction efficiency.Orthogonal test were used in evaluating the extract technology,the extraction rates oftotal anthraquinone and total polysaccharide were used to evaluate the extraction efficiency.The extraction process as follows: firstly the medicinal materials soaked in water for 1 hour;then extracted 2 times by water decoction,the amount of water added are 10 times and 8 times of medicinal materials respectively,decocting time is 1 hour for each time;mixed the extracting solution of two times,condensed and dried.3.Tablets preparation technologyThe preparation technology of Huaiming Runchang Tablets were studied according the relevant provisions in the Chinese Pharmacopoeia and National Food Safety Standards.The indexes of evaluation included: tablet appearance,friability,disintegration time,hardness,etc.Auxiliary materials species and dosage,granules moisture,drying temperature and coating process were investigated.Based on the results,the tablets preparation process as: firstly the dry medicines extract powder900 g and corn starch 150 g mix uniformly,then spray appropriate amount of 95%ethanol to granulate,drying at 50-60?,finally pellet,add magnesium stearate 8g and mix uniformly,press tablet and coat.4.Quality control standardsTo ensure the quality of Huaiming Runchang Tablets quality stable and controllable,the quality standards were researched.Thin-layer chromatography were used in the identifications of Arctium lappa,Angelica sinensis and Ophiopogon japonicus in the products.The appearance,weight variation,microbial limit,disintegration time,residue,heavy metal content,pesticide residue and tablet hardness were analyzed using the methods of the national standard of National Food Safety Standards(GB 16740-2014),Health Food and Chinese Pharmacopoeia(2015 edition).The contents of total anthraquinone and total polysaccharide in the tablets were analyzed by spectrophotometry,and sophoricoside content was analyzed by HPLC.Then we made systematic methodology studies on the content analysis methods of Spectrophotometry and HPLC.Methodology was examined for linear range,precision,exclusivity,stability and average recovery.Satisfactory results obtained from the methodology studies suggested that the established three content analysis methodswere scientific and feasible.Finally,the quality standard of Huaiming Runchang Tablets was drafted based on the research results.5.Product StabilityThe stability of the product were studied according to the provisions of the Technical Guidelines for the Study of the Stability of Traditional Chinese Medicine and Natural Medicines.The tablets appearance,disintegration time,microbial limit and effective component content,physical and chemical indexes of the products were all meet the quality standard draft requirements after six months accelerated stability testing and nine months long-termed stability testing.This results showed that the quality of Huaiming Runchang Tablets is stable.To sum up,this paper focus on the pharmaceutical researches of the Huaiming Runchang Tablets which were made of the Sophora japonica,Ophiopogon japonicus,Arctium lappa,Cassia obtusifolia.and Angelica sinensis.It may help moisten intestines and used to relieve constipation.The study results suggested that the preferred preparation process of Huaiming Runchang Tablets was scientific and feasible,the product quality was controllable and stable.