| Qianghuo Shengshi Decoction is recorded in the Internal and External Trauma Dissertation written by Jin Dong medical scientist Li Dongyuan.Its main effect is to relieve wind and dampness,treat rheumatism on the surface,strong headaches,severe back pain,pain all over,difficult to turn to the side Fever,chills,fever,and pulse floating have a unique effect.In the clinic,decoctions have been used to treat rheumatic cold cervical spondylosis,rheumatoid arthritis,osteoporosis,ankylosing spondylitis and other diseases.The preparation of the decoction is time-consuming（newly prepared when needed）,is prone to moldy deterioration for a long period of time,is not portable,difficult to take,and has a bitter taste,which is very inconvenient in clinical application.In this paper,based on the decoction,Qiang huosheng Wet Drop Pill was developed to improve the limitation of the decoction application,improve the solubility of poorly soluble drugs,improve bioavailability and stability,make the drug play quickly,and expand the scope of application.First,the optimal extraction process is determined using modern research methods.The extraction process of volatile oil is 10 times the amount of water,which is distilled for 7 hours and once for distillation.The volatile oil inclusion process is as follows: the ratio of volatile oil to β-cyclodextrin saturated aqueous solution is 1: 8,the inclusion temperature is 30 ° C,and the stirring time is 45 minutes.The water extraction process is a soaking time of 200 min,a decoction time of 3.0 h,7 times the amount of water added,and two extraction times.The alcohol precipitation process is an alcohol precipitation temperature of 10 ° C,an alcohol precipitation time of 24 hours,and an ethanol concentration of 70%.Secondly,the orthogonal test was used to determine the drip pill forming process as the matrix PEG6000: PEG8000 = 1: 1,the coolant was 201-350 cs,the upper temperature of the coolant was 30 ° C,the drop distance was 9cm,and the drug-to-base ratio was 1: 1.5.The temperature is 75 ° C,the dropping speed is 35 drops / min,and the stability and rationality of the process are confirmed through verification tests.Thirdly,in the preliminary quality evaluation research,the corresponding thin-layer identification methods of five Chinese medicines except licorice and vitex in the compound were studied.The results showed that the thin-layer chromatography spots were clear and the negative control had no interference.Systematic methodological studies were carried out on the index components of solitary living,isoimperatorin and keratin,and volatile oil component ligustilide,and the content determination method was determined.The method is simple,sensitive and highly operable.According to the 2015 edition of the Pharmacopoeia,strict quality standards were established for the medicinal materials,intermediates,and pills,and fingerprints were established to improve the quality control standards of this product throughout the entire process.Fourth,a preliminary study on the long-term stability of Qiang huo sheng Wet Drop Pills was conducted under high temperature,high humidity,accelerated conditions（40°C ± 2°C,RH75% ± 5%）and long-term conditions（25°C ± 2°C,RH60% ± 10%）conducted a preliminary stability inspection on the product,and the stability inspection results were good.In summary,the preparation process of Qianghuosheng Wet Drip Pills is reasonable,which meets the requirements of the Chinese Pharmacopoeia for drip pills,and the quality is controllable,stable and feasible. |
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