摘要
目的建立苏贝止咳颗粒中挥发油成分的质量标准。方法采用气相色谱-质谱联用(GC-MS)对挥发油提取物的成分进行鉴定,共鉴定出10个色谱峰;采用气相色谱法(GC)测定制剂中挥发油的含量,其中α-蒎烯、β-蒎烯、柠檬烯采用外标法进行测定。结果α-蒎烯、β-蒎烯、柠檬烯线性范围分别为0.590 8~75.625 mg·L^(-1)(r=1),0.778 1~24.90 mg·L^(-1)(r=1),1.719 4~220.08 mg·L^(-1)(r=1),平均加样回收率分别为102.68%(RSD=4.82%)、108.09%(RSD=6.45%)和95.59%(RSD=5.43%)(n=9)。结论所建立的方法准确、可靠、专属性强,增加了能反映制剂临床疗效的质量控制指标,为质量标准的完善提供依据。
Objective To establish quality standard of Subei zhike granules volatile oil constituents. Methods The constituents of the volatile oil extracts were identified by GC-MS,there were 10 chromatographic peaks identified. The content of volatile oil was determined by GC,α-pinene,β-pinene and limonene were determined by the external standard method. Results The linearity ranges of α-pinene,β-pinene,Limonene were 0. 5908-75. 625 mg·L - 1 （r = 1）,0. 7781-24. 90 mg·L - 1 （r = 1）,1. 7194-220. 08 mg·L - 1 （r = 1）,re-spectively. The average recovery rate was 102. 68% （RSD = 4. 82% ）,108. 09% （RSD = 6. 45% ） and 95. 59% （RSD = 5. 43% ）（n =9）,respectively. Conclusions The establishment of accurate,reliable,specific method can reflect the quality control indicators of clini-cal efficacy and provide a basis for improvement of quality standards.
出处
《安徽医药》
CAS
2017年第11期1994-1998,共5页
Anhui Medical and Pharmaceutical Journal
