纯化水英汉对照-欧洲药典8.0

WATER, PURIFIED

纯化水

H2O Mr 18.12 DEFINITION

Water for the preparation of medicines other than those that are required to be both sterile and apyrogenic, unless otherwise justified and authorized. 定义

制药用水不同于其它用水，要求它是无菌的、无热源的，除非另有调整或授权。

Purified water in bulk

散装纯化水

PRODUCTION

Purified water in bulk is prepared by distillation, by ion exchange, by reverse osmosis or by any other suitable method from water that complies with the regulations on water intended for human consumption laid down by the competent authority. Purified water in bulk is stored and distributed in conditions designed to prevent growth of micro-organisms and to avoid any other contamination. 生产：

散装纯化水是经合格的当局规定的适宜人类使用的水经蒸馏、离子交换、反渗透膜或其他任何适合的方法制备。散装纯化水存储和分配于

可防止微生物生长和可避免其他任何污染的条件下。

Microbiological monitoring During production and subsequent storage, appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored. Appropriate alert and action levels are set so as to detect adverse trends. Under normal conditions, an appropriate action level is a microbial count of 100 CFU/mL, determined by filtration through a membrane with a nominal pore size not greater than 0.45 μm, using R2A agar and incubating at 30-35 °C for not less than 5 days. The size of the sample is to be chosen in relation to the expected result. 微生物监测

在生产和其后的存储过程中，采取适当的方式以确保水的微生物数受到足够的控制和监测。设置适当的警戒限和行动限以检测不利趋势。在正常条件下，用公称孔径不大于0.45μm微孔滤膜过滤后，采用R2A琼脂于30-35°C下培养至少5天，微生物限度的行动限是100CFU/mL。检测所用的样品量根据期望的结果进行选择。

Yeast extract /酵母膏 0.5g Proteose peptone/蛋白胨 0.5g Casein hydrolysate/水解酪蛋白 0.5g Glucose/葡萄糖 0.5g Starch/淀粉 0.5 g

Dipotassium hydrogen phosphate/磷酸氢二钾 0.3 g Magnesium sulfate, anhydrous/无水硫酸镁 0.024 g Sodium pyruvate/丙酮酸钠 0.3 g Agar/琼脂 15.0 g

Purified water/纯化水 可达1000 mL

Adjust the pH so that after sterilisation it is 7.2 ± 0.2. Sterilise by heating in an autoclave at 121 °C for 15 min.

适当调整pH，使灭菌后的pH为7.2 ± 0.2。通过121 °C高压灭菌锅中加热15分钟进行灭菌。

Growth promotion of R2A agar

— Preparation of test strains. Use standardised stable suspensions of test strains or prepare them as stated in Table 0008.-1. Seed lot culture maintenance techniques (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot. Grow each of the bacterial strains separately as described in Table 0008.-1. Use buffered sodium chloride-peptone solution pH 7.0 or phosphate buffer solution pH 7.2 to make test suspensions. Use the suspensions within 2 h, or within 24 h if stored at 2-8 °C. As an alternative to preparing and then diluting a fresh suspension of vegetative cells of Bacillus subtilis, a stable spore

suspension is prepared and then an appropriate volume of the spore suspension is used for test inoculation. The stable spore suspension may be maintained at 2-8 °C for a validated period of time. R2A琼脂促生长试验：

测试菌株的制备：使用标定过的稳定的测试菌悬浮液或按表0008.-1中所述的方法制备。采用适当的菌株批保藏技术以保证菌株从原始菌株中传代次数不超过5代。根据表0008.-1描述，每次菌株分开培养。使用pH为7.0的氯化钠-蛋白胨缓冲溶液或pH为7.2的磷酸盐缓冲液制备测试悬浮液。悬浮液应在2小时内使用，如保存在2-8°C则可在24小时内使用。作为制备并稀释枯草芽孢杆菌营养细胞新鲜悬浮液的替代方法，也可以制备稳定的孢子悬浮液，然后使用体积适合的 孢子悬浮液进行接种测试。 孢子悬浮液需在2-8 °C、且已验证的期限内保存。

— Growth promotion. Test each batch ofready-prepared medium and each batch of medium, prepared either from dehydrated medium or from theingredients described. Inoculate plates of R2A agar separately with a small number(not more than 100 CFU)of the micro-organisms indicatedin Table 0008.-1. Incubate under the conditions described in the table. Growthobtained must not differ by a factorgreater than 2 from the calculated value for a standardizedinoculum. For a freshly prepared inoculum, growth ofthe micro-organisms must be comparable to that obtained with a previouslytested and approved batch of medium.

促生长试验：测试每批已制备好的培养基,以及使用脱水培养基制备或按指定成分制备的培养基。分别将表0008.-1中指定的少量菌悬液（不超过100CFU）接种在R2A琼脂上。按表中指定条件进行培养。所得的培养结果，不可超过已标定培养液的培养结果加上2的因子。对于新鲜制备的培养液，微生物的生长必须与先前测试并且已认可的批次的培养基的培养结果有可比性。

Table0008.-1. – Growth promotion of R2A agar

表 0008.-1. R2A琼脂培养基

Micro-organism 微生物 Growth Preparation of the test strain promotion 测试菌株的制备 促生长试验 Pseudomonas aeruginosa Casein soyabean digest agar or casein R2A agar soyabean digest broth /R2A琼脂 such as/铜绿假单孢菌，例如 : ATCC 9027 /大豆酪蛋白消化物琼脂培养基或液体培

本文来源：https://www.bwwdw.com/article/jtq7.html