The Key Technology Of Modern Research And Development Of Classic Famous Prescription

As the main tool of clinical treatment and the carrier of traditional medical theory,ancient classic prescriptions have always been the essence of Chinese medicine.Huaihuasan is derived from“Pu Ji Ben Shi Fang”and consists of four herbs:Sophora flos（Fried）,Platycladi cacumen（Baked with a broken pestle）,Schizonepetae herba and Fructus aurantii（To the pulp fine cut,then fried yellow with wheat bran）.It is mainly used to treat intestinal diseases caused by intestinal wind and blood poisoning.The quality control of all medicinal materials and decoction pieces of Huaihuasan met the requirements of the Chinese Pharmacopoeia.The established fingerprint methods of Platycladus platycladus leaves,Fructus Aurantii and Huaihuasan were stable,and the processing parameters of each medicinal material were clear,which could provide a beneficial exploration for the development of the unique research and development mode of classic prescription preparations.1.Textual Research on Classical Formula HuaihuasanOn the basis of the research group’s previous literature research,the research improved the research on the prescription source,herbal research,dose and clinical application of Huaihuasan by referring to ancient literature,medical database and network and other literature retrieval technologies.Huaihuasan is derived from“Pu Ji Ben Shi Fang”:The selection of medicinal materials and medicinal parts in the formulation is consistent with the varieties contained in the Chinese Pharmacopoeia（2020 edition）.According to the dosage of 1 Qian=4 g,the dosages of Sophora flos（Fried）,Platycladi cacumen（Baked with a broken pestle）,Schizonepetae herba and Fructus aurantii（To the pulp fine cut,then fried yellow with wheat bran）were 2 g.Studies have shown that Huaihuasan is mainly used in the clinical treatment of treatment of intestinal wind blood,internal hemorrhoids bleeding,ulcerative colitis bleeding and anal fissure bleeding and other diseases.2.Study on medicinal materials/decoction pieces of HuaihuasanWith the help of modern qualitative and quantitative analysis technology,the quality of high-quality raw materials of medicinal materials and decoction pieces was studied,the origin of medicinal materials was screened by combining fingerprint and chemical model analysis technology,and the processing technology of each medicinal flavor was investigated by using modern temperature control and timing equipment,so as to provide guarantee for the quality uniformity and stability of the material standard of Huaihuasan.All batches of medicinal materials meet the requirements of Pharmacopoeia,2020 edition,and are qualified medicinal materials;the fingerprints of Platycladus orientalis and Citrus aurantium were established using HPLC technology,and the origin of the medicinal materials was screened by HCA,PCA and OPLS-DA methods.the production areas of Platycladus orientalis from Pingyi of Shandong Province and Nanyang of Henan Province and Fructus Aurantii from Xinyu of Jiangxi Province and Yuanjiang of Hunan Province were optimized;The best lab-level processing method for each decoction piece:fry Sophora japonicae at 80°C for 15 min with gentle fire.The temperature is270℃,fry for 10min,fry the leaves of Platycladus orientalis black;The cutting process was 1:4and the amount of water（g:m L）was added,the softening time was 5 h,the drying temperature was 55℃,the drying time was 4 h,the frying temperature was 160℃,the frying time was 10min,the amount of bran was added 10%,and the bitter orange was fried with bran,which laid a foundation for the research on the substance benchmarks of Huaihuasan.3.Study on the key quality attributes of the substance benchmarks of HuaihuasanIn order to clarify the key quality attributes of Huaihuasan substance benchmarks,the detection method of 18 batches of Huaihuasan substance benchmarks fingerprints was established to clarify the chromatographic peak attribution,similarity range,moisture and leaching of the common peaks of the fingerprints.A basic quality evaluation method of Huaihuasan was established.The results showed that the 18 batches of Huaihuasan substance benchmarks correspond to a total of 11 common peaks calibrated for the physical objects,and the fingerprint similarity is greater than 0.98.Further summary of the indicator chemical composition information shows that Sophora flos,Platycladi cacumen,Schizonepetae herba and Fructus aurantii respectively Contribute 4,2,2,and 4 chromatographic peaks,Sophora flos（Fried）,Platycladi cacumen（Baked with a broken pestle）,Schizonepetae herba and Fructus aurantii（To the pulp fine cut,then fried yellow with wheat bran）contribute 4,1,2,and 4chromatographic peaks respectively.The water content of 18 batches of substance benchmarks was 5.75%～7.34%,and that of extract was 28.69%～33.66%,the contents of rutin,quercitrin and kurmenone were 3.22%～5.59%,0.21%～0.50%and 0.02%～0.04%respectively.4.Study on preparation technology of HuaihuasanAiming at the preparation technology of the powder and the use of modern intelligent powder characteristics instrument to study Huaihuasan,the particle size distribution of Huaihuasan and powder parameters as the criteria.The best crushing process of Huaihuasan was screened out,and the chemical properties and particle size distribution of Huaihuasan obtained by different preparation methods were preliminary studied.The in vitro cumulative dissolution of Huaihuasan with different particle sizes and dissolution media（pure water,artificial gastric juice and intestinal juice）need to be investigated,combining the modern powder preparation technology and taste,it is finally determined to prepare Huaihuasan after being mixed and crushed through a 100 mesh sieve.The latter had higher jet index,which provided a theoretical basis for the suitability of subsequent preparations.Using dry heat sterilization,wet heat sterilization,⁶⁰Co-γirradiation sterilization and microwave sterilization and other traditional Chinese medicine powder sterilization of the new technology of sterilization,further from the sterilization rate,the moisture after sterilization,the content of active ingredients and other angles,select the appropriate sterilization method.Finally,the optimum pulverization technology of Huaihuasan was selected as mixed pulverization,and the shredded decoction pieces were determined to be fried Sophora Sophora and Platycladus orientalis charcoal.The dispersion of Sophora japonicae prepared by mixed grinding is more distributed between 250μm and 355μm,and its fluidity and jet index are higher.When the mixed and crushed Huaihuasan is passed through a 100-mesh sieve,the components in the Huaihuasan have better cumulative solubility in different dissolution media.Under the sterilization conditions of dry heat at 110℃for 8 h,humid heat at 115℃for 30 min and humid heat at 121℃for 20 min,the detection results meet the microbial limit standard,and the sterilization effect has been achieved.