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OBJECTIVE：To optimize the p reparation technology of citronellol submicroemulsion. METHODS ：The content of citronellol in Citronellol submicroemulsion was determined by HPLC. Citronellol submicroemulsion by high-speed shearing dispersion-high pressure homogenization method ，with centrifugation stability constant （ke） and particle size were used as evaluation indexes. Its formulation and preparation technology were optimized and validated. Drug-loading amount and encapsulation rate of the preparation were detected. RESULTS ：The linear range of citronellol were 4-64 μg/mL（R 2＝0.999 9）. RSDs of precision ，stability（24 h）and reproducibility tests were all lower than 3％. The recoveries were 97.64％-101.97％（RSD＝ 2.28％，n＝3），97.71％-99.50％（RSD＝1.29％，n＝3），96.87％-101.48％（RSD＝2.86％，n＝3）. The optimal formulation included that total weight of soybean oil and medium chain triglycerides （1 ∶ 1，g/g）was 3.75 g，1.2％ soybean phospholipid was 0.6 g， cholesterol was 0.06 g，citronellol was 1.25 g，0.6 ％ sodium oleate was 0.3 g，15-hydroxystearic acid polyethylene glycol ester was 0.75 g，poloxamer 188 was 0.75 g，water added to 50 mL. After prepared by optimal technology at 4 ℃ which contained shearing speed of 13 000 r/min，lasting for 5 min， primary emulsion was adjusted to pH 7 with dilute hydro- chloric acid ，and homogenized with 600 Bar high pressure for 1434412440@qq.com 5 min. The parameters of Citronellol submicroemulsion accor- ding to optimal formulation and technology contained mean particle size of （91.05±0.26）nm，PDI of （0.20±0.01）， Zeta-potential of （－30.86±0.39）mV，average content of 649511230@qq.com citronellol（100.21±0.01）％，the drug-loading amount was （2.481 7 ± 0.000 7） mg/mL，the encapsulation rate was （99.27 ± 0.03）％ . CONCLUSIONS ：The optimal formulation and technology is stable and feasible.
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OBJECTIVE: To investigate the effect of poloxamer 188 as co-emulsifier on the pharmaceutical property of emulsion.METHODS: Diclofenac sodium was used as model drug and poloxamer 188 as co-emulsifier,the emulsion was prepared by high pressure homogen-colostrum pH adjusting method,with its entrapment efficiency,particle size,?-electric potential etc determined.RESULTS: The emulsion which was added with poloxamer 188 showed decreased entrapment efficiency and ?-electric potential but increased particle size as comapred with the one without poloxamer 188.CONCLUSION: The pharmaceutical property of emulsion wouldn't necessarily be enhanced by adding poloxamer 188 as co-emulsifier.
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OBJECTIVE:To prepare coenzyme Q10 submicroemulsion and investigate its stability and physico-chemical properties.METHODS:Orthogonal experiment was designed to optimize the formulation and preparation procedure of coenzyme Q10 submicroemulsion.The content and entrapment efficiency of the preparation were determined by HPLC,and its properties such as particle size,? potential,pH value and stability were studied.RESULTS:The optimal formulation and preparation procedure of coenzyme Q10 submicroemulsion were as follows:the ratio of soybean oil to medium-chain triglyceride was 1∶2;the ratio of soybean phospholipids to poloxamer 188 was 3∶1;the high speed shearing emulsification time was 10min and the preparation temperature was 60℃.The mean entrapment efficiency of 3 batches of coenzyme Q10 submicroemulsions was 98.07%,with a ? potential of —28.4mV and a mean particle size of 168 nm.Illumination and freeze thawing should be avoided for the preparation in storing,which showed a satisfactory stability at 4℃.CONCLUSION:The prepared coenzyme Q10 submicroemulsion was up to the standards of intravenous injection preparations.