| The knee osteoarthritis(KOA)is also known as knee degenerative osteoarthritis,it is common in elderly people.It is generally believed that age,wear,obesity,biochemistry,heredity and so on are the important pathogenesis of the disease.Although the disease is not life-threatening,its chronic,progressive and degenerative characteristics do seriously reduce the quality of life of patients and greatly increase the pressure of public health.With the increase of population density in China over 60 years old,the incidence of knee osteoarthritis is on the rise.Therefore,effective treatment of KOA patients and improving the quality of life of patients is a major clinical topic.Objective:Bushen-Tongluo granules is a clinical prescription that originates from Dongfang Hospitial affiliated to Beijing University of Traditional Chinese Medicine.It has remarkable curative effect to treat knee osteoarthritis.It is composed of Drynariae rhizoma,Paeoniae radix alba,Cyathulae radix,and so on.The clinical application of this prescription is oral decoction.Due to the limitation of dosage form,the patient has inconveniences to have medicine,it is also not inconvenient in drug storage and so on.This study is on the basis of the traditional theory of Chinese medicine,using modern technology to optimize methods for the extraction,purification,enrichment,drying technology and establish a quality standard using modern technology.Methods:This subject mainly includes the extraction and purification of the BuShen-Tongluo granules,the process of purification,molding process,quality standard research,pilot study and particle stability study.(1)The extraction,purification,enrichment,drying technology:According to the chemical composition,nature and the correlation of prescription therapy,the whole water extraction was selected as the extraction process of this prescription.Taking naringin and paeoniflorin extraction rate as the index,orthogonal test was used to investigate the amount of water,extraction times and extraction time.With transfer rate of naringin and paeoniflorin as index,using the single factor experiment method to inspect temperature of water concentrationthe,density of enrichment,alcohol concentration,recovery and dry temperature.Optimizing the extract concentration,purification,drying process based on them.(2)Molding process:Investigating the moisture absorption rate,primary molding rate,soft material properties,and the difficult process of granulation,and select the appropriate auxiliary materials,auxiliary ratio and wetting agent concentration.The critical relative humidity is determined by the optimum process,which provides reference for the humidity control of granulation and storage.(3)Quality standard study:The quality standard was established by TLC identification and high performance liquid phase content determination for BuShen-Tongluo granules.In this paper,the content of the standard of n-butanol extract of BuShen-Tongluo granules was established by referring to the relevant literatures.According to the related fingerprint analysis,the fingerprint of BuShen-Tongluo granules was studied.(4)Pilot study:Three batches of pilot test were conducted according to the optimized extraction and forming process,and the content determination,the content of n-butanol extract and the examination under the granules were carried out.(5)The stability:Stability of the finished products were investigated by means of accelerating stability and long-term stability of the finished product particles in the 3 batches.Results:(1)Extraction,purification,enrichment,drying process:The whole prescription was extracted 3 times,each time 1.5h,and the addition water was 8 times as the best extraction process.Extract concentrated temperature 60℃ below loss rate is lesser,the best condensed density is of 1.11～1.15(60℃),the best alcohol density is of 60%.When recovering ethanol,the temperature is controlled below 80 degrees.The drying temperature has the fewest loss rate of less than 60℃.(2)Molding process:Select the auxiliary material as dextrin.Referring to the standard of the common granules and the yield of the sample,determine the ratio of the drug to be 1:1,and the wetting agent is 85%alcohol as the best preparation condition.The particle fluidity and thawing were good,and the critical relative humidity was 83%.(3)Quality standard:Established the method of qualitative identification of bone fragments,radix paeoniae alba,radix radix radix and chuanxiong.The method of determination of the content of naringin and paeoniflorin was established,and it was stipulated that each 1 g granule containing naringin should not be less than 0.31 mg/g,and the paeoniflorin should not be less than 1.99 mg/g.The content of n-butanol extract was limited,and the content of n-butanol extract was not less than 4.4%.A preliminary study on the fingerprint of tonifying tongluo granules was carried out,and 16 of them were classified.The method can be used to identify 6 herbs in the prescription.(4)Pilot study:The average content of the three batches of granuloside was 0.39 mg/g,and the mean value of paeoniflorin was 2.49 mg/g.The positive butanol extract of three batches of test particles was 55.4 mg/g.The results of the granule under the granules of the three batches of granules,the results of particle size,water,solubility,and quantity difference are in accordance with the regulations.(5)Stability study:Under the condition of temperature(40 ± 2)℃,humidity(75±5)%,placing six months,the cotent of naringin did not change significantly,so as the content of paeoniflorin.The grain size,water,solubility and loading difference of granules,TLC identification were all consistent with the requirements.After three months of room temperature,there was no significant reduction in the content of the three batches of test particles.And the grain size,water,solubility and loading difference of granules,TLC identification were all consistent with the requirements.Conchusion:In this paper,a stable and feasible preparation technology research was established and the qualified finished products were prepared by the study of the purification,concentration,drying process and the forming process of BuShen-Tongluo granules.Through the research of quality standard,the TLC identification and content determination and n-butyl alcohol extract standard is established.The method is stable,feasible.The fingerprint of BuShen-Tongluo granules was preliminarily explored.Three batches of pilot experiments were carried out,and the stability of the finished product is good. |
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