現(xiàn)行的各國藥典的檢測方法和標(biāo)準(zhǔn)都統(tǒng)一,下面試列出各國藥典的原文供參考:
1. 中國藥典2010版-詳見附件【中國藥典2010不溶性微粒檢測方法】
光阻法
1.1 標(biāo)示裝量為100mL或100mL以上的靜脈注射液 除另有規(guī)定外,每1mL中含10µm以上的微粒不超過25粒,含25µm以上的微粒不超過3粒,判為符合規(guī)定。
如果每1mL中含10µm以上的微粒數(shù)超過25粒;或雖未超過25粒,但其中含25µm以上的微粒超過3粒時(shí);均判為不符合規(guī)定。
1.2 標(biāo)示裝量為100mL以下的靜脈注射液、靜脈注射液用無菌粉末及注射用濃溶液除另有規(guī)定外,每個(gè)供試品容器中含10µm以上的微粒不得過 6000粒,含25µm以上的微粒不得過600粒,判為符合規(guī)定。
如果每個(gè)容器中含10µm以上的微粒數(shù)超過6000粒,或雖未超過6000粒,但其中含25µm以上的微粒超過600粒時(shí);均判為不符合規(guī)定。
顯微計(jì)數(shù)法:
1. 標(biāo)示裝量為100mL或100mL以上的靜脈注射液 除另有規(guī)定外,每1mL中含10µm以上的微粒不超過12粒,含25µm以上的微粒不超過2粒,均為符合規(guī)定。
如果每1mL中含10µm以上的微粒數(shù)超過12粒;或雖未超過12粒,但其中含25µm以上的微粒超過2粒時(shí);均判為不符合規(guī)定。
2. 標(biāo)示裝量為100mL以下的靜脈注射液、靜脈注射用無菌粉末及注射用濃溶液除另有規(guī)定外,每個(gè)供試品容器中含10µm以上的微粒不超過3000粒,含25µm以上的微粒不超過300粒,判為符合規(guī)定。
如果每個(gè)容器中含10µm以上的微粒數(shù)超過3000粒;或雖未超過3000粒,但其中含25µm以上的微粒超過300粒;均判為不符合規(guī)定。
2. 美國藥典(USP35-788)-詳見附件USP35-788
光阻法LIGHT OBSCURATION PARTICLE COUNT TEST
For preparations supplied in containers with a nominal volume of more than 100 mL, apply the criteria of Test 1.A.
For preparations supplied in containers with a nominal volume of less than 100 mL, apply the criteria of Test 1.B.
For preparations supplied in containers with a nominal volume of 100 mL, apply the criteria of Test 1.B. [NOTE—Test 1.Ais used in the Japanese Pharmacopoeia.]
If the average number of particles exceeds the limits, test the preparation by the Microscopic Particle Count Test.
Test 1.A (Solutions for parenteral infusion or solutions for injection supplied in containers with a nominal content of more than 100 mL)—The preparation complies with the test if the average number of particles present in the units tested does not exceed 25 per mL equal to or greater than 10 µm and does not exceed 3 per mL equal to or greater than 25 µm.
Test 1.B (Solutions for parenteral infusion or solutions for injection supplied in containers with a nominal content of less than 100 mL)—The preparation complies with the test if the average number of particles present in the units tested does not exceed 6000 per container equal to or greater than 10 µm and does not exceed 600 per container equal to or greater than 25 µm.
顯微計(jì)數(shù)法MICROSCOPIC PARTICLE COUNT TEST
For preparations supplied in containers with a nominal volume of more than 100 mL, apply the criteria of test 2.A.
For preparations supplied in containers with a nominal volume of less than 100 mL, apply the criteria of test 2.B.
For preparations supplied in containers with a nominal volume of 100 mL, apply the criteria of test 2.B.
Test 2.A – Solutions for infusion or solutions for injection supplied in containers with a nominal content of more than 100 mL. The preparation complies with the test if the average number of particles present in the units tested does not exceed 12 per millilitre equal to or greater than 10 µm and does not exceed 2 per millilitre equal to or greater than 25 µm.
Test 2.B – Solutions for infusion or solutions for injection supplied in containers with a nominalcontent of less than 100 mL. The preparation complies with the test if the average number of particles present in the units tested does not exceed 3000 per container equal to or greater than 10 µm and does not exceed 300 per container equal to or greater than 25 µm.
3. 英國藥典<BP2012>-詳見附件BP2012
和美國藥典<USP35-788>一致。
4. 歐洲藥典<EP8.0>,詳見附件EP8.0
和美國藥典<USP35-788>一致。
5. 日本藥典<JP16>,詳見附件JP16
和美國藥典<USP35-788>個(gè)別文字描述不同,其他一致。
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