美國(guó)藥典-頭孢曲松鈉-中英文對(duì)照

1、Ceftriaxone Sodium(USP32)Ceftriaxone sodium contains the equivalent of not less than 795ug of ceftriaxone per mg,calculated on the anhydrous(無(wú)水的) basis.本品按無(wú)水物計(jì)算，每毫克頭孢曲松鈉含頭孢曲松不得少于795微克。Packaging and storage-preserve in the tight containers.包裝和貯藏-貯藏于密閉容器中。Labeling（標(biāo)簽）-where it is intended for use in p

2、reparing injectable(血管注射劑，可注射的) dosage（劑量，用量） forms（注射劑型）, the label states that it is sterile（無(wú)菌的） or must be subjected to further processing during the preparation of injectable dosage forms.標(biāo)簽-當(dāng)預(yù)期用于注射劑時(shí)，標(biāo)簽應(yīng)說(shuō)明無(wú)菌或者必須可以用于制備注射劑的后續(xù)處理。USP Reference standards<11>-USP Ceftriaxone Sodium RS(對(duì)照品).標(biāo)準(zhǔn)品

3、USP Ceftriaxone sodium E-Isomer（反式同分異構(gòu)體） RS.USP Endotoxin（內(nèi)毒素） RS.Identification-A:Infrared Absorption<197K>B:The chromatogram(色譜圖) of the Assay preparation（含量測(cè)定溶液） obtained as directed in the assay（含量測(cè)定項(xiàng)下的） exhibits（顯示） a major peak for ceftriaxone, the retention time（保留時(shí)間） of which correspon

4、ds to（相當(dāng)于） that exhibits in the chromatogram of the Standard preparation obtained as directed in the assay.含量測(cè)定項(xiàng)下的含量測(cè)定溶液的色譜圖中頭孢曲松主峰的保留時(shí)間和含量測(cè)定項(xiàng)下的標(biāo)準(zhǔn)溶液的色譜圖中頭孢曲松主峰保留時(shí)間相一致。C:It responds to the test for Sodium、。顯鈉鹽反應(yīng)。Crystallinity(結(jié)晶度) <695>:meets the requirements.符合規(guī)定（要求）Ph<791>:between 6.0 a

5、nd 8.0 in a solution (1in 10).溶液pH值需在6.0到8.0之間（1/10）。Water,Method I<921>:between 8.0%and 11.0%.水分，方法I：需在8.0%到11.0%之間。Other requirements-Where the label states that ceftriaxone sodium is sterile（無(wú)菌的）, it meets the requirements for Sterility（無(wú)菌） and Becterial endotoxins（細(xì)菌內(nèi)毒素） under Ceftriaxone

6、for injection（注射用頭孢曲松）.Where the label states that Ceftriaxone Sodium must be subjected to further processing during the preparation of injectable dosage forms,it meets the requriments for bacterial endotoxins under Ceftriaxone for infection.其他規(guī)定-當(dāng)標(biāo)簽說(shuō)明頭孢曲松鈉是無(wú)菌時(shí)，應(yīng)滿足注射用頭孢曲松項(xiàng)下的無(wú)菌和細(xì)菌內(nèi)毒素的規(guī)定。當(dāng)標(biāo)簽說(shuō)明頭孢曲松鈉在制備

7、注射劑的過(guò)程中，需進(jìn)行后續(xù)處理時(shí)。它應(yīng)該滿足注射用頭孢曲松項(xiàng)下的細(xì)菌內(nèi)毒素的規(guī)定。Assay- pH7.0 buffer-Dissolve 13.6g of dibasic potassium phosphate and 4.0g of monobasic potassium phosphate in water to obtain 1000ml of solution,Adjust this soluton with phosphoric acid or 10N potassium hydroxide to a pH of 7.0+-0.1.pH7.0緩沖液-取13.6g的磷酸氫二鉀和4.0

8、g的磷酸氫一鉀溶于水中并稀釋至1000ml溶液，加入磷酸或者是10mol/l的氫氧化鉀調(diào)節(jié)溶液pH值為（7.0+-0.1）.pH5.0 buffer-dissolve 25.8g of sodium citrate in 500ml of water, adjust with citric acid solution (1 in 5) to a pH of 5.0+-0.1,and dilute with water to a volume of 1000ml.pH5.0緩沖液-取25.8g檸檬酸鈉溶解于500ml水中，加入檸檬酸溶液（1/5）調(diào)節(jié)ph值至（5.0+-0.1），并加水稀釋至10

9、00ml.Mobile phase-Dissolve 3.2g of tetraheptylammonium bromide(四庚基溴化氫) in 400ml of acetonitrile（乙腈）, add 44ml of pH 7.0 buffer and 4ml of pH 5.0 buffer ,and add water to make 1000ml, Filter （過(guò)濾）through a membrane filter（膜濾器） of 0.5um or finer porosity（細(xì)孔隙度）, and degas（脫氣）.Make adjustment if necessar

10、y (see system suitability under chromatography<621>)流動(dòng)相-取3.2g 四庚基溴化氫溶于400ml乙腈，并加入44ml pH為7.0 緩沖液和4ml pH為5.0的緩沖液，加水稀釋至1000ml.用0.5um的濾膜或跟細(xì)小的濾膜過(guò)濾，脫氣。如果有需要應(yīng)適當(dāng)做調(diào)整。（參閱色譜法項(xiàng)下的系統(tǒng)適用性。）Standard preparation-Dissolve an accurately weighed quantity of USP ceftriaxone sodium RS in mobile phase, to obtain a s

11、olution having a known concentration（濃度） of about 0.2mg per ml . Use this solution promptly（立即的、迅速的） after preparation .標(biāo)準(zhǔn)溶液的配制-精密稱定適量的USP頭孢曲松鈉標(biāo)準(zhǔn)品溶于移動(dòng)相中。制成已知濃度為每ml為0.2mg的溶液。配置后立即使用。Resolution(分離度) solution(分離度測(cè)試溶液)-Dissolve a suitable quantity of USP Ceftriaxone sodium e-isomer RS in standard soluti

12、on , and dilute with mobile phase to obtain a solution containing about 160ug of USP Ceftriaxone sodium e-isomer RS per ml and 160ug of USP ceftriaxone sodium RS per ml .Use this solution promptly after preparation .分離度測(cè)試溶液-取適量的USP頭孢曲松鈉反式同分異構(gòu)體的標(biāo)準(zhǔn)品，溶解于標(biāo)準(zhǔn)溶液中。加入流動(dòng)相稀釋至每ml溶液含USP頭孢曲松鈉反式同分異構(gòu)體標(biāo)準(zhǔn)品160ug及每ml含U

13、SP頭孢曲松鈉標(biāo)準(zhǔn)品160ug的溶液。配置后應(yīng)立即使用。Assay preparation -Tranfer about 40mg of Ceftriaxone sodium ,accurately weighed,to a 200ml volumetric flask（容量瓶）,dissolve in and dilute with mobile phase to volume,and mix.Use this solution promptly after preparation .供試品溶液配制-取頭孢曲松鈉約40mg，精密稱定，至200ml容量瓶中。加入流動(dòng)相溶解并稀釋至刻度，混勻。配

14、置后因立即使用。Chromatographic system （see chromatography <621>）-The liquid chromatography(液相色譜儀) is equiped with a 270-nm detector（檢測(cè)器） and a 4.0-mm*15-mm column（圓柱） that contains 5-um packing（填充物） L1.The flow rate（流速） is about 2ml per minute. Chromatograph the resolution solution（向色譜儀中注射分離度測(cè)試溶液） ,a

15、nd record the peak responses as directed under procedure:the resolution,R, between the ceftriaxone e-isomer and ceftriaxone peaks is not less than 3.chromatograph the standard preparation ,and record the peak responses as directed under procedure:the column efficiency（柱效應(yīng)） determined from the analyt

16、e peak（分析峰） is not less than 1500 theoretical plates（理論板數(shù)） ;the tailing factor（拖尾因子） for the analyte peak is not more than 2;and the relative standard deviation（相對(duì)標(biāo)準(zhǔn)偏差） for replicate injections（重復(fù)進(jìn)樣） is not more than 2%.色譜系統(tǒng)（參閱色譜法）-液相色譜的組成：檢測(cè)器波長(zhǎng)：270-nm，色譜柱：5um填料L1，規(guī)格：4.0-mm*15mm.流速為2ml/min,量取分離溶液，注入

17、液相色譜中，按照程序項(xiàng)下記錄記錄峰響應(yīng)：頭孢曲松鈉反式同分異構(gòu)體和頭孢曲松鈉的分離度應(yīng)不小于3，量取適量標(biāo)準(zhǔn)液，注入色譜柱，按照程序項(xiàng)下記錄峰響應(yīng)：據(jù)分析峰而得的柱效應(yīng)不低于1500理論板數(shù)，分析峰的拖尾因子應(yīng)不大于2；重復(fù)進(jìn)樣的相對(duì)標(biāo)準(zhǔn)偏差不大于2%。Procedure-Separately inject equal volumes (about 20ul) of the standard solution and the assay preparation into the chromatograph, record the chromatograms, and measure the r

18、espones for the major peaks. Calculate the quantity, in ug, of ceftriaxone (c18h18n8o7s3)per mg of the ceftriaxone sodium taken by the formula: 200(CP/M)(ru/rs)In which C is the concentration(濃度) , in mg per ml, of USP ceftriaxone sodium RS in the standard preparation ; P is the desigenated potency（標(biāo)示含量，效價(jià)）, in ug of ceftriaxone per mg,of USP ceftriaxone sodium RS ; W is the quantity, in mg , of the ceftriaxone sodium taken to prepare the assay preparation ; and ru and rs are the ceftriaxone peak responses obtained from the a