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1、美国药典中英文对照美国药典中英文对照译文美国药典中记载的辣椒碱资料辣椒碱（辣椒素）分子结构式：C18H27NO3，分子量： 305.41，化学名：（反）N（4N羟基3甲氧基苯基）甲基8甲基6壬烯基酰胺以干燥提取物计算，辣椒碱含辣椒二萜类化合物总量为标示量的90100%,其中辣椒素的含量达到 50以上，辣椒素和二氢辣椒素总量超过75，其它辣椒素类化合物总量不足 15。注意事项：小心处置辣椒碱，谨防吸入辣椒碱微粒，勿使身体接触辣椒碱。包装贮藏：密封包装，置避光，阴凉处保存。标示量：以辣椒二萜类化合物总百分含量表示。美国药典参考标准：美国药典辣椒素标准规范，美国药典二氢辣椒素标准规范。鉴别：配制 1
2、.0mg/ml 辣椒碱甲醇溶液，配制符合美国药典标准的辣椒碱1.0mg/ml 甲醇溶液作为对照液，分别点样于 0.25mm 厚硅胶、凝胶混合薄层板上，点样量为 10 礚，将薄层板放于乙醚甲醇（19:1）展开剂中展开，待展开剂前沿至薄层板 3/4 处时将薄层板取出，晾干，用 0.5% 2,6-二溴苯醌-氯化亚胺甲醇溶液喷雾显色，放于氨气中片刻，取出，鉴别色谱图：供试液主要斑点颜色（兰色）及 R 值与对照液主要斑点颜色（兰色）及 R 值一致。熔点741: 5766, 一般熔融起始温度至结束温度温差不超过 5。干燥失重731: 置 40P2O5 真空干燥器中干燥 5 小时，失重不超过1.0%。灼烧残
3、渣：1.0。辣椒素，二氢辣椒素及其它辣椒二萜类化合物含量测定：流动相：磷酸水溶液（l ：1000，V/V）：乙腈(600:400)混匀，0.5 祄 微孔滤膜滤过，脱气。流动相视色谱行为可作适当调整。辣椒素对照液：精密称取美国药典标准的辣椒碱适量溶于甲醇中，配制约 0.1 mg/mL 的辣椒甲醇溶液。二氢辣椒素对照液：精密称取美国药典标准的辣椒碱适量溶于甲醇中，配制约 0.025mg/mL 的辣椒甲醇溶液。供试液：精密量取辣椒碱约 25 mg 于 250 mL 容量瓶中，甲醇稀释至刻度，摇匀。色谱条件：检测波长 281 nm，色谱柱（4.6 mm x 250 cm，5 祄），柱温：30，调流速使
4、辣椒碱主要色谱峰保留时间约为 20 min。 记录辣椒碱对照液色谱图及峰面积，重复进样，RSD2%。样品处理：辣椒素对照液，二氢辣椒素对照液，供试液分别进样 20 礚 ，记录色谱图至两倍主要色谱峰保留时间，记录所有色谱峰面积，按公式 25,000(C/W)(ru/rs)计算辣椒素百分含量, 公式中 C 为辣椒素对照液浓度，单位 mg/ mL,W为供试液中辣椒碱含量，单位 mg，ru 和 rs 分别代表供试液中和对照液中辣椒素峰面积。辣椒素含量不低于 55。按公式 25,000(C/W)(ru/rs)计算二氢辣椒素含量，公式中 C 为二氢辣椒素对照液浓度，单位 mg/mL, W 为供试液中辣椒素
5、含量，单位为 mg, ru 和 rs 分别代表供试液和对照液中二氢辣椒素峰面积。测得辣椒素和二氢辣椒素总百分含量不低于 75%. 根据记录供试液和对照液色谱图峰面积，按公式 25,000(C/W)(ru/rs)计算其它辣椒二萜类化合物百分含量，公式中 C 为对照液中辣椒素浓度，单位 mg/mL，W 为供试液中辣椒素含量，单位为 mg，ru 为供试液中其它辣椒二萜类化合物而非辣椒素、二氢辣椒素峰面积之和，rs 为对照液中辣椒素峰面积。其它辣椒二萜类化合物总百分含量不超过 15。C18H27NO3 305.416-Nonenamide, (E)-N-(4-Hydroxy-3-methoxy-phe
6、nyl)methyl-8-methyl.(E)-8-Methyl-N-vanillyl-6-nonenamide 404-86-4.Capsaicin contains not less than 90.0 percent and not more than 110.0 percent of the labeled percentage of total capsaicinoids.The content of capsaicin (C18H27NO3) is not less than 55 percent, and the sum of the contents of capsaicin
7、and dihydrocapsaicin (C18H29NO3) is not less than 75 percent, and the content of other capsaicinoids is not more than 15 percent, all calculated on the dried basis.CautionHandle Capsaicin with care. Prevent inhalation of particles of it and prevent its contact with any part of the body.Packaging and
8、 storagePreserve in tight containers, protected from light, and store in a cool place.LabelingLabel it to state the percentage content of total capsaicinoids.USP Reference standards11USP Capsaicin RS. USP Dihydrocapsaicin RS.IdentificationPrepare a test solution of Capsaicin in methanol containing l
9、 mg per mL. Prepare a Standard solution of USP Capsaicin RS in methanol containing l mg per mL. Separately apply 10 -礚 portions of the test solution and the Standard solution to a thin-layer chromatographic plate(see Chromatography 21)coated with a 0.25-mm layer of chromatographic silica gel mixture
10、. Develop the chromatograms in a solvent system consisting of a mixture of ether and methanol (19:1) until the solvent front has moved about threefourths of the length of the plate. Remove the plate from the chamber, and allow it to air-dry. Spray the plate with a 0.5% solution of 2,6-dibromoquinone
11、-chlorimide in methanol, allow to stand in a chamber containing ammonia fumes, and examine the chromatograms:the blue color and the R value of the principal spot obtained from the test solution correspond to those properties of the principal spot obtained from the Standard solution.Melting range741:
12、 between 57and 66, but the range between beginning and end of melting does not exceed 5.Loss on drying731: Dry it in vacuum over phosphorus pentoxide at 40for 5 hours: it loses not more than 1.0% of its weight.Residue on ignition281: not more than 1.0%.Content of capsaicin, dihydrocapsaicin, and oth
13、er capsaicinoidsMobile phasePrepare a mixture of diluted phosphoric acid (l in 1000) and acetonitrile (600:400). Filter through a filter having a porosity of 0.5 祄 or finer, and degas. Make adjustments if necessary (see System Suitability under Chromatography621).Standard dihydrocapsaicin solutionDi
14、ssolve an accurately weighed quantity of USP Capsaicin RS quantitatively in methanol to obtain a solution having a known concentration of about 0.1 mg per mL.Standard dihydrocapsaicin solutionDissolve an accurately weighed quantity of USP Dihydrocapsaicin RS quantitatively in methanol to obtain a so
15、lution having a known concentration of about 0.025 mg per mL.Test solutionTransfer about 25 mg of Capsaicin, accurately weighed, to a 250-mL volumetric flask, dilute with methanol to volume, and mix.Chromatographic system (see Chromatography621) The liquid chromatograph is equipped with a 281-nm det
16、ector and a 4.6-mm x 25-cm column that contains 5-m packing L11 and is maintained at a constant temperature of about 30. Adjust the flow rate to obtain a retention time of about 20 minutes for the main capsaicin peak. Chromatograph the Standard capsaicin solution, and record the peak responses as directed for procedure: the relative standard deviation for replicate injections is not more than 2%.ProcedureSeparately inj
