美国药典-中英文对照(翻译资料)

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－[（4

－N－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90％－

100%,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1.0mg/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〉: 57°－66°, 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40°P2O5真空干燥器中干燥5小时，失重不超过

1.0%。

灼烧残渣：≤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，RSD≤2%。

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 305.41

6-Nonenamide,

(E)-N-[(4-Hydroxy-3-methoxy-phenyl)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 content of

capsaicin (C18H27NO3) is not less than 55 percent, and the sum of the

contents of capsaicin 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.

Caution——Handle Capsaicin with care. Prevent inhalation of particles of it and

prevent its contact with any part of the body.

Packaging and storage——Preserve in tight containers, protected from

light, and store in a cool place.

Labeling——Label it to state the percentage content of total

capsaicinoids.

USP Reference standards〈11〉——USP Capsaicin RS. USP

Dihydrocapsaicin RS.

Identification——Prepare a test solution of Capsaicin in methanol

containing l 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. 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-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 range〈741〉: between 57°and 66°, but the range between

beginning and end of melting does not exceed 5°.

Loss on drying〈731〉: Dry it in vacuum over phosphorus pentoxide at

40°for 5 hours: it loses not more than 1.0% of its weight.

Residue on ignition〈281〉: not more than 1.0%.

Content of capsaicin, dihydrocapsaicin, and other capsaicinoids—Mobile

phase—Prepare 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 Chromatography

〈621〉).

Standard dihydrocapsaicin solution—Dissolve 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 solution—Dissolve an accurately weighed quantity

of USP Dihydrocapsaicin RS quantitatively in methanol to obtain a solution

having a known concentration of about 0.025 mg per mL.

Test solution—Transfer about 25 mg of Capsaicin, accurately weighed, to a

250-mL volumetric flask, dilute with methanol to volume, and mix.

Chromatographic system (see Chromatography〈621〉) —The liquid

chromatograph is equipped with a 281-nm detector and a 4.6-mm x 25-cm

column that contains 5-μm 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%.

Procedure—Separately inject equal volunes (about 20 μL) of the

Standard capsaicin solution, the Standard dihydrocapsaicin solution, and the

Test solution into the chromatograph, record the chromatogram for a period of

time that is twice that of the retention time of capsaicin, and measure the areas

of the responses for all of the peaks. Calculate the percentage of capsaicin

(C18H27NO3) in the portion of Capsaicin taken by the formula:

25,000(C/W)(gu/gs),

in which C is the concentration, in mg per mL, of USP Capsaicin RS in

the Standard capsaicin solution, W is the weight, in mg, of Capsaicin taken to

prepare the Test solution, and ru and rs are the capsaicin peak responses

obtained from the Test solution, and the Standard ate the percentage of

dihydrocapsaicin (C18H29NO3) in the portion of Capsaicin taken by the formula:

25,000(C/W)(gu/gs),

in which C is the concentration, in mg per mL, of USP Dihydrocapsaicin

RS in the Standard capsaicin solution, W is the weight, in mg, of Capsaicin

taken to prepare the Test solution, and ru and rs are the dihydrocapsaicin peak

responses obtained from the Test solution and the Standard dihydrocapsaicin

solution, respectively. The sum of the percentage of capsaicin found and of the

percentage of dihydrocapsaicin found is not less than 75%. Using the

chromatograms obtained from the Standard capsaicin solution and the Test

solution, calculate the percentage of other capsaicinoids in the portion of

Capsaicin taken by the formula:

25,000(C/W)(gu/gs),

in which C is the concentration, in mg per mL, of USP Capsaicin RS in

the, W is the weight, in mg, of Capsaicin taken to prepare the Test solution, rT

is the sum of the peak responses of the capsaicinoids other than capsaicin and

dihydrocapsaicin in the chromatogram obtained from the Test solution, and rs

is the capsaicin peak response obtained from the Standard capsaicin solution.

Not more than 15% of other capsaicinoids is found.

[[i] 本帖最后由 tinalongding 于 2008-12-8 17:24 编辑 [/i]]

2008-12-8 17:23 tinalongding

Papain

Papain [9001-73-4]

Papain is a purified proteolytic substance derived from Carica papaya

Linné(ceae).papain,when assayed directed herein, contains not less

than 6000 units per mg. Papain of a higher digestive power may be reduced to

the official standard by admixture with papain of lower activity ,lactose,or other

suitable diluents.

One USP Unit of papain is the activity that releases the of 1μg of tyrosine from

a specified casein substance under the conditions of the Assay， using the

enzyme concentration that liberates 40μg of tyrosine per mL of test solution.

Packaging and storage－Preserve in tight,light-resistant containers in a cool

place.

USP reference standards (11)—USP papain RS.

pH<791>:between 4.8 and 6.2 in a solution (1 in 50).

Loss on drying <731>—Dry it in a vacuum oven at 60℃ for 4 hours : it losses

not more than 7.0% of its weight.

Assay (casein digestive power)—

Dibasic sodium phosphate.,0.05M—dissolve 7.1g of anhydrous dibasic sodium

phosphate in water to make 1 drop of toluene as a preservative.

Citric acid,0.05M—dissolve 10.5g of citric acid monohydrate in water to make

1000mL. Add 1 drop on toluene as a preservative.

Casein substrate—Disperse 1 g of Hammersten-type casein in 50 mL on

0.05M Dibasic sodium phosphate. Place in a boiling water bath for 30 minutes

with occasional to room temperature ,and add 0.05 M Citric acid to

adjust to a pH of 6.0± the solution rapidly and continuously during the

addition of the 0.05M Citric acid to prevent precipitation of the casein. Dilute

with water to 100 mL .prepare fresh daily.

Buffer solution (Phosphate-Cysteine Disodium ethylenediaminetetraacetate

Buffer) —dissolve 3.55g of anhydrous dibasic phosphate in 400mL of water in a

500-mL volumetric 7.0 g of disodium EDTA and 3.05 g of cysteine

hydrochloride monohydrate. Adjust with 1 N hydrochloric acid or 1 N sodium

hydroxide to a pH of 6.0±0.1 . dilute with water to volume ,and mix. Prepare

fresh daily.

Trichloroacetic acid solution —Dissolve 30g of reagent grade trichloroacetic

acid in water. and dilute with water to 100mL. This solution may be stored at

room temperature.

Standard preparation —Weigh accurately 100 mg of USP Papain RS in a 100-mL

volumetric flask. And add Buffer solution to dissolve. Dilute with Buffer solution

to volume, and mix. Transfer 2.0 mL of this solution to a 50-mL volumetric flask,

dilute with Buffer solution to volume, and mix. Use within 30 minutes after

preparation.

Assay preparation—Transfer an accurately weighed amount of

papain.,equivalent to about 100mg of USP Papain RS, to a 10-mL volumetric

flask, dilute with Buffer solution to volume, and mix. Transfer 2.0 mL of this

solution to a 50-mL volumetric flsk, dilute with Buffer solution to volume, and

mix.

Procedure—Into each of 12 test tubes (18-×150-mm) pipet 5.0 mL of casein

substrate. Place in a water bath at 40°, and allow 10 minutes to reach bath

temperature. Into each of two of the tubes (the tests are run in duplicate

except for the blanks) labeled S1 ,pipet 1.0 mL of the Standard preparation

and 1.0mL of the Buffer solution, Mix by swirling , note zero time,insert the

stopper, and replace in the bath . Into each of 2 other tubes ,labeled S2 pipet

1.5mL of standard . preparation and 0.5 mL of Buffer solution , and proceed as

before . Repeat this procedure for 2 tubes ,labeled S3to which 2.0mL of

standard preparation is added , and for 2 tube ,labled U2,to which 1.5mL of

Assay preparation and 0.5mL Buffer solution are 60

minutes,accurary timed,add to all 12 tubes 3.0 mL of trichloroacetic acid

solution,and shake vigorously . With the 4 tubes to which no standard

preparation or Assay preparation were added,prepare blanks by

pipeting,respectively ,1.0mL of standard preparation and 1.0 mL of Buffer

solution 1.5mL of standard preparation and 0.5 mL of Buffer solution;2.0mL of

standard preparation;and 1.5mL Assay preparation and 0.5 mL of Buffer

e all tubes in the 40° water bath for 30 to 40 minutes,to allow to

coagulate fully the precipitated through medium-porosity filter

paper,discarding the first 3 mL of the filtrate(filtrates used are clear).Read the

absorbances at 280 nm,of the filtrates if all solutions against their respective

the absorbance readings for S1,S2¬ and S3 against the enzyme

concentration of each corresponding interpolation from this

curve,taking into consideration dilution factors,calculate the potency in Units,in

the weight of papain taken by the formula.:

(50,000/3)CA,

In which 50,000/3 is a factor derived by the expression 100(50/2)(10/1.5),C is

the concentration,in mg per mL,obtained from the standard curve,and A is the

activity of the Reference Standard in Units per mg.

翻译仅供参考：

木瓜蛋白酶

木瓜蛋白酶[9001-73-4]

木瓜蛋白酶是一种源自番木瓜乳汁（ceae）的纯化的水解蛋白物。木

瓜蛋白酶在这里定向检测时其含量不得少于6000单位每毫克。具有较高的消化

能力的木瓜蛋白酶也许可以通过掺加低活力的木瓜蛋白酶，乳糖或者其他合适的

填充物来降低消化能力以达到官方的标准。

定义木瓜蛋白酶一个USP活力单位为在测定条件下指定的酪蛋白物质释放1μg

酪氨酸所需要的量，所用的酶试液的浓度相当与每毫升释放40μg酪氨酸 。

包装与保藏—包装要包紧，保存在避光，阴凉的地方

USP 参考标准（11）—USP 木瓜蛋白酶 R.S

pH<791>在溶液中介于4.8与6.2之间（1 in 50？）

干燥失重<731>—60℃时在真空干燥箱中干燥4小时：失重不得少于本身的7.0％

检测（酪蛋白消化能力）

0.05M磷酸氢二钠溶液—准确称取7.1g无水磷酸氢二钠用蒸馏水水溶解并定

容至1000mL。加一滴甲苯作为防腐剂。

0.05M柠檬酸—准确称取10.5g柠檬酸一水合物用蒸馏水溶解并定容至

1000mL。加一滴甲苯作为防腐剂。酪蛋白底物—将1g Hammersten-type 酪蛋

白分散于50mL磷酸氢二钠溶液中，将上述溶液沸水浴加热30分钟并在必要时

搅拌。酪蛋白溶解后冷却至室温再用0.05M柠檬酸调节pH至6.0±0.1。为了防

止酪蛋白沉淀，加入0.05M柠檬酸的过程中要不断的快速搅拌。然后将上述溶

液定容至100mL，临时现配。

缓冲溶液（磷酸盐—半胱氨酸－磷酸氢二钠EDTA－2Na缓冲）

——准确称取3.55g二代磷酸盐用400mL水溶解移入到500mL的容量瓶中，同

时加入7.0g EDTA及3.05g 半胱氨酸盐酸盐一水物。用1mol/L盐酸或1mol/L

氢氧化钠溶液调至pH6.0±0.1。用水稀释至刻度，混匀，临用现配。

三氯乙酸溶液—准确称取30g 试剂级三氯乙酸用水溶解并定容到100mL。此溶

液可以保存于室温。

标准试剂—精确称取100mg RS级USP木瓜蛋白酶置于100mL容量瓶中，加入

缓冲溶液使之溶解，再用缓冲溶液定容至刻度，混匀。移取2.0mL此溶液置于

50mL容量瓶中，然后用缓冲溶液定容至刻度，混匀。配好后30min内用。

待测试剂—将准确称取的与100mg USP RS级木瓜蛋白酶当量的木瓜蛋白酶移

入100mL的容量瓶中，用缓冲溶液稀释至刻度，混匀。移取2mL此溶液到50mL

容量瓶中并用缓冲溶液定容至刻度，混匀。

步骤——用吸量管每次吸取5ml酪蛋白底物分别加往12支试管（18×150mm）

中，将试管置于40°水浴加热10分钟以使溶液达到水浴温度。然后每两管（除

空白之外其他管操作完全相同）标上S1 ，往上述两管中吸入1.0mL标准试剂和

1.0mL缓冲溶液，涡流混匀，记下开始时间，加入终止剂，放回水浴中。其他两

管标上S2 吸入1.5mL标准溶液和0.5mL缓冲溶液，以后操作同前。对两试管

重复此过程标上S3 吸入2.0mL标准试剂，对后拿两试管标上U2 加入1.5mL

待测试剂和0.5mL缓冲溶液。精确计时60分钟后，往所有的12支试管中加入

3.0ml三氯乙酸溶液并剧烈震荡。同时准备四支没有加入标准试剂或待测试剂的

试管作为空白对照分别加入1.0mL标准试剂和1.0mL缓冲溶液，1.5mL标准试

剂和0.5mL缓冲溶液，2.0mL标准试剂以及1.5mL待测试剂和0.5mL缓冲溶液。

将所有试管放回40℃水浴30分钟到40分钟以便使蛋白质沉淀物完全凝结。用

中等孔径滤纸过滤，弃去首先收集的3mL滤液（所用的滤液要是清澈的）。分

别读出溶液滤液在其相应的空白作为参比溶液下在280nm处的吸光度。将

S1,S2¬ 和 S3对应的吸光度读数对各自相应的酶浓度水平作图。通过对图

像用内插法，并考虑稀释因子，用单位，木瓜蛋白酶质量计算通过下述公式计算

其效价：(50,000/3)CA

其中50,000/3源自表达式100（50/2）（10/1.5）得到的因数，C表示浓度

单位：mg/mL，从标准曲线获得，A表示参比标准的活力单位：单位/毫克