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01/2011:50104
5.1.4.
MICROBIOLOGICAL QUALITY OF NON-STERILE
PHARMACEUTICAL PREPARATIONS AND
SUBSTANCES FOR
PHARMACEUTICAL USE (1)
非无菌制剂和药用物质的微生物质量
The presence of certain micro-organisms
in non-sterile preparations may
have
the potential to reduce or even inactivate the
therapeutic activity of the
product and
has a potential to adversely affect the health of
the patient.
在非无菌制剂中如果存在某些微生物，可能会降低或抑制药
物的治疗活性，
可能会对病人健康有潜在不良影响。
Manufacturers therefore
have to ensure a low bioburden of finished dosage
forms by implementing current
guidelines on Good Manufacturing Practice
during the manufacture, storage and
distribution of pharmaceutical
preparations.
因此，生产商应在药品生产、存
贮和销售过程中遵守现行
GMP
指南，来保
证制剂的微生物在一个较低的水平。
Microbial examination of non-sterile
products is performed according to the
methods given in general chapters
2.6.12 and 2.6.13. Acceptance criteria
for non-sterile pharmaceutical products
based upon the total aerobic
microbial
count (TAMC) and the total combined yeasts/moulds
count
(TYMC) are given in Tables
5.1.4-1 and 5.1.4-2. Acceptance criteria are
based on individual results or on the
average of replicate counts when
replicate counts are performed (e.g.
direct plating methods).
非无菌产品微生物检查应依据通
则
2.6.12
和
2.6.13
中指定的方法进行。
非无
菌制剂的细菌数
（
TAMC
）
和霉
菌酵母菌总数
（
TYMC
）
可接受标准见表
5.1.4-1
和表
5.1.4-2
。可接受标准是基于单个计算结果或多个计数（例如碟式直接
计
数法）结果的平均值。
When an acceptance criterion for
microbiological quality is prescribed it is
interpreted as follows:
可接受标准的解释如下
—
10
1
CFU: maximum
acceptable count = 20;
—
10
1
CFU:
：最大可接受计数结果
=20
—
10
2
CFU: maximum
acceptable count = 200;
—
10
2
CFU:
：最大可接受计数结果
=200
—
10
3
CFU: maximum
acceptable count = 2000, and so forth.
—
10
3
CFU:
：最大可接受计数结果
=2000
，依此类推
Table 5.1.4.-1
includes a list of specified micro-organisms for
which
acceptance criteria are set. The
list is not necessarily exhaustive and for a
given preparation it may be necessary
to test for other micro-organisms
depending on the nature of the starting
materials and the manufacturing
process.
表
5.1.4-1
包括控制菌清单及其可接受标准。
清单并未列出制剂需要检验的
全
部控制菌，需要检测的菌种业依起始物料和生产工艺而定。
Table 5.1.4-1. Acceptance
criteria for microbiological quality of non-
sterile
dosage forms
表
5.1.4.-1
非无菌制剂微生物可接受标准
Route of administration
给药方式
TAMC
总细
菌计数
(CFU/g or
CFU/mL)
TYMC
霉菌
和酵母菌总
数
(CFU/g or
CFU/mL)
Specified
micro-organisms
控制菌
N
on-aqueous preparations for
10
3
oral use
口服非水制剂
Aqueous
preparations for oral
10
2
use
口服水型制剂
Rectal
use
10
3
直肠给药
2
Oromucosal use
口腔粘膜给药
10
Gingival use
齿龈给药
Cutaneous
use
皮肤给药
Nasal
use
鼻给药
Auricular
use
耳给药
10
2
Absence of Escherichia coli (1g
or 1 mL)
大肠杆菌不得检出
（
1g
或
1ml
）
10
1
Absence of Escherichia coli (1g
or 1 mL)
大肠杆菌不得检出
（
1g
或
1ml
）
10
2
10
1
Absence of Staphylococcus
aureus (1 g or 1 mL)
Absence of Pseudomonas
aeruginosa (1 g or 1 mL)
金黄色葡萄球菌不得检出
（
1g
或
1ml
）
铜绿假单胞菌不得检出（
1g
或
1ml
）