Study On Optimization Of HuangKui Capsule Processing Technology And Its Quality Improvement

Abelmoschus Corolla is originated from the corolla of Abelmoschus manihot(L.)Medic that comes from Abelmoschus of Malvaceae.It was recordedfirstly in the Book ofMateria medica with Jiayou.The drug is the smell of fragrance and sweet taste.Huangkui Capsule with prescribed preparation was made of Abelmoschus Corolla.It can reduce glomerular inflammation of immune reactions,reduce urinary protein,reduce the swelling and relieve pain,etc.It is widely used in the treatment of chronic nephritis and the effect is very goodHuangkui Capsule had many deficiencies and was needed to further study with it’s expansion of industry and depth of the clinical application.In terms of production process,this paper studied Huangkui Capsule in the extraction process,the drying process and the molding process.In terms of the quality standard,the current quality standard was mainly for the material and the end product.On the basis of original standard,this paper study on optimization of HuangKui Capsule’s quality improvement.The study not only provided a reference for improvement of the production process in the future,but also improved the quality control of the Huangkui Capsule each link in production,and provided the scientific basis for quality research of Huangkui CapsuleTechnological aspects(1)According to the content of total flavonoids,rutin,hyperoside,isoquercitrin,myricetin,quercitrin and extraction rate,orthogonal experimental designs were employed to select the best extracting procedure.The ideal extraction process was 2 times of extraction,15 times of 70%alcohol,50min of reflux.(2)According to drying transfer rate of rutin,hyperoside,isoquercitrin,myricetin,quercitrin and drying time and material appearance,the experiment was employed to comparing the different drying methods of vacuum-belt drying,scraper drying and vacuum drying.vacuum-belt drying is better than scraper drying and vacuum drying in material appearance,and the drying transfer rate of rutin was 89.63%-93.05%,hyperoside was 94.11%-94.69%,isoquercitrin was 94.53%-94.70%,myricetin was 93.48%-94.19%and quercitrin was 93.07%-96.32%.Vacuum-belt drying is the best drying method for Huangkui Capsule(3)In the study of molding process,according to moisture absorption of materials,this paper filtered the kind and amount of excipients.And then,this paper studied the formulation process of capsule,such as percentage of moisture absorption,buik density,angle of repose and so on,which were investigated in order to provide a reference of improving Huangkui Capsule production process.Quality standards:(1)On the basis of original standard,this paper established the microemulsion thin-layer chromatography for identifying materials,intermediates and end products of Huangkui Capsule.The optimum developer of microemulsion contain 80%water.Spots were clear and round comparing with the other developer.(2)Contents of the five flavonoids(Rutin,Hyperoside,Isoquercitrin,Myricetin,Quercitrin)have a good resolution with the correlation coefficients exceed 0.9999.Chromatograms of 10 different lots of materials,intermediates and end products of Huangkui Capsule have been analyzed with the similarities over 0.9.This paper established the content determination method of total flavonoids of materials,intermediates and end products of Huangkui Capsule by UV.The proposed method of contents determination and chromatogram analysis has a strong characteristic and specificity.This method is fast,easy and reliable,and can be applied for quality control of the preparation.(3)Checking item for the optimized product was the amount of difference,heavy metals and arsenic salts and other research.The results are complianced with the 2010 version of Pharmacopoeia.Innovation point:(1)Optimizing the extraction procedure of Huang Kui Capsule,selecting vacuum-belt drying and optimizing excipients,is to improve moisture absorption and fluidity of materials(2)This paper established qualitative identification methods of medicinal materials,intermediates and end products of Huangkui Capsule by microemulsion TLC.This paper established the fingerprint detection methods of materials,intermediates and end products of Huangkui Capsule by HPLC.This paper established the content determination method of total flavonoids and five kinds of flavonoids of materials,intermediates and end products of Huangkui Capsule.