1.Optimization of prescription process of lifitegrast eye drops and evaluation of its efficacy for dry eye disease
Xi YAN ; Yunan PAN ; Kaili WANG ; Qianzi XU ; Yan SHEN ; Yang LU
Journal of China Pharmaceutical University 2024;55(2):209-216
In order to develop a more effective drug for dry eye disease, the preparation of lifitegrast eye drops was carried out, and the safety and efficacy of lifitegrast eye drops in vitro and in vivo were investigated. First the method for the determination of lifitegrast content was established, and then the composition and preparation process of the preparation were determined by literature review and single factor experiment. Finally, the safety of lifitegrast eye drops was evaluated by Draize eye irritation test and HE staining, and the therapeutic efficacy was evaluated by Schirmer test and ELISA test. The results showed that the final prescription of lifitegrast eye drops consisted of 5% lifitegrast, 0.4% sodium chloride, 0.3%−0.4% anhydrous disodium hydrogen phosphate, 0.3% sodium thiosulfate pentahydrate and 0.3% sodium hydroxide. The appearance of lifitegrast eye drops was transparent and slightly brownish yellow solution, the pH was7.75±0.05, the osmotic pressure was in the range of 200−330 mOsmol/kg and it had good stability at 60℃ for 3 months. There was no significant difference in irritation study compared with normal saline. Schirmer test showed that tear secretion was increased and the expression of inflammatory factors IL-6, IL-1β and TNF-α in tears were significantly decreased after treatment with lifitegrast eye drops and compared to the commercially available emulsion cyclosporine eye drops, it takes effect faster. The above results indicate that lifitegrast eye drops are simple to prepare and stable, which is a better choice for the rapid treatment of dry eye disease.
2.Content Determination of 10 Kinds of Active Componets in Tibetan Medicine Siwei Jianghuang Prescription and Its Decoction Technology Optim ization
Xiaoyan WANG ; Yunan XIANG ; Jie GAO ; Lin PAN ; Ruohong BI ; Xianrong LAI ; Qi’en LI ; Xianjia LI
China Pharmacy 2020;31(8):913-919
OBJECTIVE:To e stablish the method for simultaneous determination of 10 kinds of active components in Tibetan medicine Siwei jianghuang prescription ,and to optimize its decoction technology. METHODS :HPLC method was adopted. Using soaking time ,the amount of added water ,decoction time and decoction times as factors ,comprehensive score of the contents of 10 kinds of components and solid extracts rate as response values ,one the basis of single factor test ,Box-Behnken response surface method was used to optimize its decoction technology. RESULTS :The linear range of gallic acid ,corilagin,magnoflorine, ellagic acid , hydrochloric jatrorrhizine , hydrochloride palmatine , hydrochloride berberine , bisdemethoxycurcumin, demethoxycurcumin and curcumin were 0.280 6-1.683 6,0.289 6-1.737 6,0.320 8-1.924 8,0.116 0-0.696 0,0.018 9-0.113 5, 0.013 3-0.079 9,0.092 3-0.553 8,0.025 5-0.153 0,0.036 1-0.216 3,0.041 0-0.245 7 µg(all r were 0.999 9),respectively. The limits of quantitation were 0.28,14.48,3.21,11.60,1.89,4.44,0.46,0.26,0.36,0.41 ng,respectively. The limits of detection were 0.11,4.14,1.24,3.32,0.58,1.33,0.13,0.09,0.14,0.12 ng,respectively. RSDs of precision ,stability and reproducibility tests were all lower than 3%. The recoveries were 92.56%-103.69%(RSDs were 0.90%-3.81%,n=6). The optimal decoction technology included soaking 60 min,adding 8-fold(mL/g)water,decoction for twice ,lasting for 65 min each time. In 6 validation tests ,comprehensive scores were 3.323 2-3.422 4,and the absolute value of the relative error with the predicted value (3.437 4)was less than 2%.CONCLUSIONS:Established method is simple and repeatable ,and can be used for simultaneous determination of 10 kinds of active components in Siwei jianghuang prescription. Optimized decoction technology is stable and feasible.
3.Bouquet technique in treatment of unstable pediatric femoral shaft fractures
Yunan LU ; Ran LIN ; Nuoqi PAN ; Yuling HUANG ; Bin CHEN ; Shunyou CHEN
Chinese Journal of Orthopaedic Trauma 2022;24(12):1042-1048
Objective:To investigate the clinical results of Bouquet technique [multiple elastic stable intramedullary nails (ESIN)] in the treatment of unstable pediatric femoral shaft fractures.Methods:From August 2016 to October 2019, 25 pediatric patients (26 sides) with unstable femoral shaft fracture were treated with Bouquet technique at Department of Pediatric Orthopedics, The Second Fuzhou Hospital Affiliated to Xiamen University. They were 17 boys and 8 girls, with a mean age of 7.8 years at injury (from 5 to 11 years). Their body weight ranged from 23 kg to 62 kg, with an average of 36.3 kg. Long oblique fractures happened in 6 cases (6 sides) and comminuted fractures in 19 cases (20 sides). Ten cases (11 sides) were fixated with 3 ESINs (type 3A) and 15 cases (15 sides) with 4 ESINs (type 4A in 6 cases and type 2A+2B in 9 cases). The multiple ESINs were inserted from the medial and lateral cortex of the distal femur through the fracture sides until the head ends of the nails were distributed evenly at the proximal femur. Recorded were the fracture healing time, complications, fracture reduction quality and hip function at the last follow-up.Results:All the 25 patients were followed up for 18 to 27 months (mean, 22.4 months). Their fractures got united after 4 to 8 weeks (mean, 6.3 weeks). One case presented with femoral overgrowth of 1.1 cm and another case with nail tail irritation. Follow-ups revealed that none of the patients had such complications as incision infection, limited joint movement, nonunion or delayed fracture union. The limb alignment recovered well with no angulation, shortening or rotational deformity. At the last follow-up, according to the efficacy evaluation system for intramedullary nails by Flynn et al., the quality of reduction of femoral shaft fractures was assessed as excellent in 24 sides and as good in 2 sides, giving an excellent and good rate of 100% (26/26). According to the hip Harris scoring system, the hip function was assessed as excellent in all the 26 sides, giving an excellent rate of 100% (26/26).Conclusion:Bouquet technique is safe and effective in the treatment of unstable pediatric femoral shaft fractures, leading to fine clinical results.