Study New Type Gel Preparation Of Tongluozhitong Prescription And Its Clinical Observation On The Treatment Of Knee Osteoarthritis

BackgroundTongluozhitong Recipe,with Guizhi and Baiji as the vital part of medicine,supplemented with peach kernel,safflower,frankincense,myrrh,Achyranthes bidentifolia,Aconitum,Asarum,and Chuanjiao,is selected by Professor Qingfu Wang from his clinical practice in orthopedics for more than 40 years.The traditional Chinese medicinal herbs used for the treatment of osteoarthrosis of the knee,such as osteoarthrosis of the knee joint,have been used for the external detoxification of water decoction,and later developed a Tongluozhitong patch for use with the low-frequency penetration instrument.Clinical observation confirmed that Tongluo Zhitong Patch has good effect on knee osteoarthritis and has the best effect in treating knee spasm of meridian syndrome.Basic research shows that cinnamon aldehyde and total glucosides of paeony can inhibit knee osteoarthritis Synovial fibroblast activity,Tongluozhitongfang decoction can reduce the release of interleukin-1β(IL-1β),tumor necrosis factor-α(TNF-α)and other inflammatory mediators.In the treatment of knee osteoarthritis and other degenerative diseases with clinical collaterals Tongluozhitong,there are obvious limitations in the use of external devices.In order to better play the role of Tongluozhitong,it is urgent to use more convenient external dermatologic formulations.After consulting a large amount of literature and information,it was decided that Tongluozhitong should be made into a gelling agent containing cinnamic aldehyde liposomes.The prepared gelling agent was initially used for the clinical treatment of knee osteoarthrosis.The safety and efficacy were preliminary verified,and preliminary clinical data were accumulated.Fundamental research sectionPurpose:To produce the Tongluozhitong gel containing liposome of cinnamaldehyde and evaluate it for quality.Method:The cinnamaldehyde liposome was made by film dispersion method,the free drug section in cinnamic aldehyde liposome was separated by ultrafiltration,the drug content was determined by HPLC,and the encapsulation efficiency of cinnamaldehyde liposome was calculated,also the cholesterol and egg were used.The proportion of phospholipids,the ratio of cinnamaldehyde to auxiliaries,hydration temperature,pH value of phosphate buffer salt were the influencing factors.The evaluation of the basic quality of Tongluo Zhitong gel was performed by a scoring method.Result:The optimal formulation of cinnamaldehyde liposome was as follow:the mass ratio of cholesterol to lecithin was 1:8,the total ratio of cinnamaldehyde to cholesterol lecithin was 1:12,the pH was 7.0,and the hydration temperature was 55 ℃.The cinnamaldehyde liposome entrapment efficiency was 82.71%and the drug loading was 5.32%.According to the sensory index of the gelling agent and the comprehensive evaluation criteria of the experimental indicators,the prepared Tongluozhizhi gel was evaluated with a score of>=12 points.Conclusion:The prepared Tongluozhitong gel meets the quality standard and the contains of the cinnamaldehyde liposome encapsulation rate and the drug loading can reach the standard.Clinical observation sectionObjective:To observe the clinical efficacy of Tongluozhitong gel in the treatment of knee osteoarthritis.Method:Three groups of Tongluozhitong gel external preparation group,Ultrasound-assisted traditional Tongluo Zhitong patch group and blank group were established.The consistency of the three groups in the form of treatment was established.Patients with knee osteoarthropathy were selected for a certain period of time.Treatments were performed in batches and randomized into groups to compare VAS scores and knee function scores before and after treatment.The active flexion of the knee and the passive horizontal movement range of the d patella were examined before and after the treatment of the test group.Results:The overall difference was checked by Kruskal—Wallis H test,and the Nemenyi test was used for the comparison.In terms of pain score before and after treatment,p<0.01,which showed the difference between the three groups was statistically significant.The external use group of Tongluo Analgesic Gel was statistically significant compared with the blank group(p<0.01),but there was no statistically significant difference between this group and the pain-relieving patch group.The functional scores before and after treatment were p<0.05.The difference between the three groups was statistically significant.The topical group of Tongluo Analgesic Gel was statistically significant compared with the blank group(p<0.01),no statistical difference between the ultrasound-transparent traditional Tongluo pain-relieving patch group.Paired t-test was used in 29 cases of the experimental group before and after the control.In terms of active flexion of the knee joint,p<0.05,the increase of knee flexion before and after treatment was statistically significant.The range of passive motion of the patella was p<0.01,and the improvement of the passive range of the tibia before and after treatment was statistically significant.Conclusion:For the treatment of knee osteoarthritis,topical Tongluo Analgesic Gel and Low Frequency Promoting Tongluo Analgesic Patch can.both significantly alleviate knee pain and improve knee function activity.There is no obvious difference in pain relieving,Tongluo analgesic gel is better in improving joint motion,but the advantage is not statistically significant.Tongluo Analgesic Gel can also significantly increase the knee flexion and the passive range of motion of the patella in patients with knee osteoarthritis.