W/O型黄芩苷纳米乳的制备及质量评价
|
摘要
目的制备W/O型黄芩苷纳米乳并对其质量进行评价。方法通过优化处方工艺制得W/O型黄芩苷纳米乳,并对其外观、粒径、载药量及稳定性进行考察,采用高效液相色谱法测定纳米乳中黄芩苷的含量,检测波长为280nm。结果 W/O型黄芩苷纳米乳为均一透明的液体,平均粒径为(63.40±1.10)nm,载药量为9.5mg/mL。黄芩苷在12.40～310.00μg/mL浓度范围内与峰面积线性关系良好,r=0.999 7。高、中、低质量浓度的黄芩苷供试品溶液平均加样回收率分别为99.88%、99.01%、100.31%,RSD均小于0.87%。黄芩苷纳米乳在常温和低温条件下贮存30d,含量无明显变化。结论制备的W/O型黄芩苷纳米乳质量稳定可靠,建立的高效液相色谱法操作简便、快捷、重复性好,可用于测定纳米乳中黄芩苷的含量。
Objective To prepare water-in-oil(W/O)baicalin nanoemulsion and assess its quality.Methods W/O baicalin nanoemulsion was prepared by the optimized formulation process.The appearance,particle size,drug loading,and stability of W/O baicalin nanoemulsion were investigated.High-performance liquid chromatography(HPLC)was performed at a detection wavelength of 280 nm to determine the content of baicalin in nanoemulsion.Results W/O baicalin nanoemulsion was uniform transparent liquid,with an average particle size of(63.40±1.097)nm and a drug loading of 9.5 mg/mL.The concentration of baicalin showed a good linear relationship with peak area within 12.40-310.00μg/mL(r=0.999 7).The average recovery rates of high-,middle-,and low-concentration baicalin sample solutions were 99.88%,99.01%,and 100.31%,respectively,with relative standard deviations of<0.87%.No significant change in the content of baicalin was observed after baicalin nanoemulsion was stored at normal or low temperature for 30 days.Conclusion The prepared W/O baicalin nanoemulsion has stable and reliable quality.The established HPLC method is simple,efficient,and repeatable,and can be used to determine baicalin in nanoemulsion.
Objective To prepare water-in-oil(W/O)baicalin nanoemulsion and assess its quality.Methods W/O baicalin nanoemulsion was prepared by the optimized formulation process.The appearance,particle size,drug loading,and stability of W/O baicalin nanoemulsion were investigated.High-performance liquid chromatography(HPLC)was performed at a detection wavelength of 280 nm to determine the content of baicalin in nanoemulsion.Results W/O baicalin nanoemulsion was uniform transparent liquid,with an average particle size of(63.40±1.097)nm and a drug loading of 9.5 mg/mL.The concentration of baicalin showed a good linear relationship with peak area within 12.40-310.00μg/mL(r=0.999 7).The average recovery rates of high-,middle-,and low-concentration baicalin sample solutions were 99.88%,99.01%,and 100.31%,respectively,with relative standard deviations of<0.87%.No significant change in the content of baicalin was observed after baicalin nanoemulsion was stored at normal or low temperature for 30 days.Conclusion The prepared W/O baicalin nanoemulsion has stable and reliable quality.The established HPLC method is simple,efficient,and repeatable,and can be used to determine baicalin in nanoemulsion.
引文
[1]WU H,LIU Z,PENG J,et al.Design and evaluation of baicalin-containing in situ pH-triggered gelling system for sustained ophthalmic drug delivery[J].International Journal of Pharmaceutics,2011,410(1):31-40.
[2]GAO X,GUO M,ZHANG Z,et al.Baicalin promotes the bacteriostatic activity of lysozyme on S.aureus in mammary glands and neutrophilic granulocytes in mice[J].Oncotarget,2017,8(12):19894-19901.
[3]李新成,王宏伟,申保生,等.黄芩苷联合干扰素α治疗慢性乙型肝炎疗效及对细胞免疫的影响[J].中国现代药物应用,2014,8(2):3-5.
[4]HUANG H,ZHOU W,ZHU H,et al.Baicalin benefits the anti-HBV therapy via inhibiting HBV viral RNAs[J].Toxicol Appl Pharmacol,2017,323:36-43.
[5]ZIGNEGO A L,PILUSO A,GIANNINI C.HBV and HCV chronic infection:autoimmune manifestations and lymphoproliferation[J].Autoimmunity Reviews,2008,8(2):107-111.
[6]UMEDA M,MARUSAWA H,SENO H,et al.Hepatitis B virus infection in lymphatic tissues in inactive hepatitis B carriers[J].Journal of Hepatology,2005,42(6):806-812.
[7]CHU M,XIAO X,MA J,et al.In vivo real-time near-infrared fluorescent mapping of sentinel lymph nodes using methylene blue encapsulated in a microemulsion nanosystem[J].Current Nanoscience,2010,6(4):388-396.
[8]KAWAKAMI K,YOSHIKAWA T,MOROTO Y,et al.Microemulsion formulation for enhanced absorption of poorly soluble drugs:Ⅰ.Prescription design[J].Journal of Controlled Release,2002,81(1-2):65-74.
[9]李萌,王杏林,葛志强,等.HPLC法测定依托泊苷亚微乳中的药物含量[J].中国新药杂志,2007,16(17):1390-1392.
[10]史亚军,吴品江,许润春,等.黄芩苷磷脂复合物基本性质研究[J].中草药,2012,43(1):78-82.
[11]中华人民共和国药典委员会.中华人民共和国药典:一部[M].北京:化学工业出版社,2015:301.
[2]GAO X,GUO M,ZHANG Z,et al.Baicalin promotes the bacteriostatic activity of lysozyme on S.aureus in mammary glands and neutrophilic granulocytes in mice[J].Oncotarget,2017,8(12):19894-19901.
[3]李新成,王宏伟,申保生,等.黄芩苷联合干扰素α治疗慢性乙型肝炎疗效及对细胞免疫的影响[J].中国现代药物应用,2014,8(2):3-5.
[4]HUANG H,ZHOU W,ZHU H,et al.Baicalin benefits the anti-HBV therapy via inhibiting HBV viral RNAs[J].Toxicol Appl Pharmacol,2017,323:36-43.
[5]ZIGNEGO A L,PILUSO A,GIANNINI C.HBV and HCV chronic infection:autoimmune manifestations and lymphoproliferation[J].Autoimmunity Reviews,2008,8(2):107-111.
[6]UMEDA M,MARUSAWA H,SENO H,et al.Hepatitis B virus infection in lymphatic tissues in inactive hepatitis B carriers[J].Journal of Hepatology,2005,42(6):806-812.
[7]CHU M,XIAO X,MA J,et al.In vivo real-time near-infrared fluorescent mapping of sentinel lymph nodes using methylene blue encapsulated in a microemulsion nanosystem[J].Current Nanoscience,2010,6(4):388-396.
[8]KAWAKAMI K,YOSHIKAWA T,MOROTO Y,et al.Microemulsion formulation for enhanced absorption of poorly soluble drugs:Ⅰ.Prescription design[J].Journal of Controlled Release,2002,81(1-2):65-74.
[9]李萌,王杏林,葛志强,等.HPLC法测定依托泊苷亚微乳中的药物含量[J].中国新药杂志,2007,16(17):1390-1392.
[10]史亚军,吴品江,许润春,等.黄芩苷磷脂复合物基本性质研究[J].中草药,2012,43(1):78-82.
[11]中华人民共和国药典委员会.中华人民共和国药典:一部[M].北京:化学工业出版社,2015:301.