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溶液澄清度中國藥典與歐洲藥典

溶液澄清度
中**藥典:
附錄Ⅸ B澄清度檢查法
本法系在室溫條件下,將用水稀釋**一定濃度的供試品溶液與等量的濁度標
準液分別置于配對的比濁用玻璃管(內徑 15~16mm,平底,具塞,以無色、透
明、中性硬質玻璃制成)中,在濁度標準液制備 5 分鐘后,在暗室內垂直同置于傘棚燈下,照度為 1000 lx,從水平方向觀察、比較;用以檢查溶液的澄清度或其渾濁程度。除另有規定外,供試品溶解后應立即檢視。
   品種項下規定的“澄清”,系指供試品溶液的澄清度相同于所用溶劑,或未
超過 0.5 號濁度標準液。“幾乎澄清”則指供試品溶液的濁度介于 0.5 號** 1 號濁度標準液的濁度之間。
濁度標準貯備液的制備 稱取于105℃干燥**恒重的硫酸肼1.00g,置100ml
量瓶中,加水適量使溶解,必要時可在 40℃的水浴中溫熱溶解,并用水稀釋**
刻度,搖勻,放置 4~6 小時;取此溶液與等容量的 10%烏洛托品溶液混合,搖勻,于 25℃避光靜置 24 小時,即得。本液置冷處避光保存,可在兩個月內使用,用前搖勻。
濁度標準原液的制備 取濁度標準貯備液 15.0ml,置 1000ml 量瓶中,加水
稀釋**刻度,搖勻,取適量,置 1cm 吸收池中,照紫外-可見分光光度法(附錄Ⅳ A),在 550nm 的波長處測定,其吸光度應在 0.12~0.15 范圍內。本液應在 48小時內使用,用前搖勻。
濁度標準液的制備 取濁度標準原液與水,按下表配制,即得。本液應臨用
時制備,使用前充分搖勻。
級號 0.5 1 2 3 4
濁度標準原液/ml 2.50 5.0 10.0 30.0 50.0
水/ml 97.50 95.0 90.0 70.0 50.0
 
 
 
 
 
 
歐洲藥典:
Clarity and degree of opalescence of liquids
VISUAL METHOD一般方法
Using identical test-tubes of colourless, transparent, neutral glass with a flat base and an internal diameter of 15-25 mm, compare the liquid to be examined with a reference suspension freshly prepared as described below, the depth of the layer being 40 mm. Compare the solutions in diffused daylight 5 min after preparation of the reference suspension, viewing vertically against a black background. The diffusion of light must be such that reference suspension I can readily be distinguished from water R, and that reference suspension II can readily be distinguished from reference suspension I.
在內徑15~25mm,平底,無色、透明、中性玻璃管中,加入等量的供試溶液與濁度標準液,使液位的深度都為40mm,按如下所述方法進行比較。濁度標準液制備5分鐘后,以色散自然光照射濁度標準溶液和供試溶液,在黑色背景下從垂直方向觀察、比較澄清度或渾濁程度。色散自然光**較容易區分濁度標準溶液Ⅰ與水,濁度標準溶液Ⅱ與濁度標準溶液Ⅰ
A liquid is considered clear if its clarity is the same as that of water R or of the solvent used when examined under the conditions described above, or if its opalescence is not more pronounced than that of reference suspension I.
如果供試溶液的澄清、透明程度與水相同,或者與所用溶劑相同,或者其澄清度不超過Ⅰ號濁度標準溶液,那么可判定該溶液為澄清。
 
Hydrazine sulfate solution. Dissolve 1.0 g of hydrazine sulfate R in water R and dilute to 100.0 mL with the same solvent. Allow to stand for 4-6 h.
硫酸肼溶液:取1.0g硫酸肼溶于水,加水稀釋**100.0ml,靜置4~6小時。
 
Hexamethylenetetramine solution. In a 100 mL ground-glass-stoppered flask, dissolve 2.5 g of hexamethylenetetramine R in 25.0 mL of water R.
烏洛托品(六亞甲基四胺)溶液 :在100ml容量瓶中,以25.0ml水溶解2.5g烏洛托品。
 
Primary opalescent suspension (formazin suspension).  
To the examethylenetetramine solution in the flask add 25.0 mL of the hydrazine sulfate solution. Mix and allow to stand for 24 h. This suspension is stable for 2 months, provided it is stored in a glass container free from surface defects. The suspension must not adhere to the glass and must be well mixed before use.
濁度標準貯備液:在存放烏洛托品溶液的100ml容量瓶中,加25.0ml的硫酸肼溶液?;旌?,靜置24小時,貯存在無表面要求的玻璃容器中,可在2個月內使用。該濁度液不得黏附玻璃,用前**充分搖勻。
 
Standard of opalescence. Dilute 15.0 mL of the primary opalescent suspension to 1000.0 mL with water R. This suspension is freshly prepared and may be stored for up to 24 h.
濁度標準原液:取濁度標準貯備液15ml,加水稀釋、定容**1000ml。該液臨用前制備,**多保存24小時。
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