3、工艺路线： Technical Processes:
调pH至* Regulate the pH to *
半落塞 Half plugged
过滤除菌 Filtering and sterilization
真空压塞 Vacuum tapping
出箱、轧盖、检验 Boxing, covering and testing
成品 Finished products
4、制备工艺研究 Research on preparation technics
4.1配料：在l万级洁净区按处方量秤取*、*，用处方量*％的*溶解，加入*，加热至沸0.5小时，冷却，过滤，加入处方量的*，加注射用水至规定体积，用0.1mol／L氢氧化钠调pH至*，经0.45／0.22μm滤膜过滤。
Preparation: in 10,000 level clean area, * were measured according to the prescription and *% of the prescription amount were dissolved. * was then added. The mixture was heated to boiling for 0.5 hours, cooled and filtered. A prescription amount of * was added and the injection water was filled up to the nominal volume. The solution was regulated by 0.1 mol/L NaOH to pH * and filtered by 0.45/0.22 μ m membrane.
4.2分装：在100级洁净区内，经灌装器分装，0.5ml／瓶，半落塞。
Filling: In the100 level clean area, the solution was filled into 0.5ml bottles by filling machine and half plugged.
4.3冷冻干燥：分装制品进箱后，预冻3小时，搁板温度至-40℃以下，制品温度为-40℃以下，开真空泵制品开始升华，升华阶段制品温度控制在-5℃以下，待水线到底后，制品温度缓慢升温至40℃，搁板温度为40-45℃，保温4小时，真空下压塞出箱。
Freeze drying: after bottled, they were pre-frozen for 3 hours. The temperature of the lay plate was below -40 ℃, so did the products. When the vacuum pump was opened, the products started the sublimation, over which the temperature of the products were controlled under -5 ℃. When the waterline reached the bottom, the temperature of the products gradually increased to 40℃, and that of lay plate to 40-45 ℃. The temperature was kept for 4 hours, and they were tapped under the condition of vacuum.
4.4包装：制品出箱后，轧盖，检验合格后，包装得成品。
Packaging: after boxed, covered and tested, the products were then packaged and finished.
4.5冻干曲线(见图5-9、5-10、5-11)。
Freeze Drying Curve (See Fig 5-9、5-10、5-11)。
华译网上海翻译公司曾经翻译过大量有关制备工艺研究和影响因素试验资料文件。
Beijing Chinese Subtitling Translation Service Agency has translated many technical documents about Research on preparation technics and Affecting Factor test.
5、影响因素试验 样品批号：Affecting Factor test Sample lot No.:
5.1光照试验 Light Test
取本品，放置于强光照射之下(5000L×)，室温下(20-25℃)观察10天，按临床前研究用质量标准(草案)考察样品的稳定性。结果如下：(见图5-12至5-20)：
This product was placed under strong light (5000 L ×), at room temperature (20-25 ℃) for 10 days to observe the stability in accordance with Quality Standards for Preclinical Studies (Draft). The results were as follows: (See fig. 5-12 to 5-20):结果表明本品在强光照射下10天，质量有明显变化，说明本品应避光保存。
The results showed that the quality of this product had significant change under the strong light lasting for 10 days, which indicated that this product should be stored in dark places.
5.2高温60℃条件 At high temperature 60℃
取本品，放入60℃烘箱中10天，分别于第5天和第10天取样，考察本品的稳定性，结果如下(见图5-21至图5-26)。
This product was placed into the 60℃ oven for 10 days and sampled on the 5th and 10th day. The stability results were as follows (See Fig 5-21to Fig 5-26).
结果表明本品60℃烘箱中10天，质量有明显变化，说明本品对高温不稳定。
The results showed that the quality of this product had significant changes at 60℃ oven for 10 days, which indicated that this product was unstable at high temperature.
本品在光照和60℃条件下放置不稳定，故生产时应避光和控制温度。
This product was unstable under the condition of strong light and 60℃ and thus the production of it should avoid light and had temperature controlled.
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