盐酸左西替利嗪口服溶液抑菌体系的评价研究.pdfVIP

盐酸左西替利嗪口服溶液抑菌体系的评价研究

11111,21*

王静，周发友，戴翚，肖璜，曹蕊，马仕洪(1.中国食品药品检定研究院，

北京

100050；2.北京四环科宝制药股份有限公

司，

北京

102629)

摘要：目的

对2021年国家药品评价性抽验品种盐酸左西替利嗪口服溶液的抑菌效力及其抑菌剂使用情况进行评价，分

析其抑菌体系对微生物污染的控制能力。方法参照中国药典2020年版二部阿昔洛韦滴眼液的方法对8家企业的样品开

展抑菌剂种类筛查；根据企业提供的方法对添加抑菌剂的6家企业的样品进行抑菌剂含量测定；根据中国药典2020年版

四部通则1121抑菌效力检查法，评判样品的抑菌性是否满足药典要求。结果8家企业所有样品抑菌剂的种类、添加量均

与处方一致。抑菌效力检查结果显示，添加抑菌剂的6家企业的样品均满足药典规定，未添加抑菌剂的2家企业的样品，

1家满足规定、1家不满足规定。结论抽验的盐酸左西替利嗪口服溶液均未发现违规添加或滥用抑菌剂的情况，但抑菌

体系是否为最优处方存疑，建议生产企业结合辅料特性、水分活度等，基于风险评估的理念开展评价，优化处方设计，建

立更合理的抑菌体系。

关键词：盐酸左西替利嗪口服溶液；尼泊金酯类抑菌剂；抑菌体系；抑菌效力；种类筛查；含量测定

中图分类号：R917文献标志码：B文章编号：1007-7693(2025)03-0430-07

DOI:10.13748/ki.issn1007-7693

引用本文：王静,

周发友,

戴翚,

等.

盐酸左西替利嗪口服溶液抑菌体系的评价研究[J].

中国现代应用药学,

2025,

42(3):

430-

436.

EvaluationoftheAntimicrobialSystemofLevocetirizineDihydrochlorideOralSolution

11111,21*

WANG

Jing,

ZHOU

Fayou,

DAI

Hui,

XIAO

Huang,

CAO

Rui,

MA

Shihong(1.NationalInstitutesforFoodand

DrugControl,Beijing100050,China;2.BeijingSHKBPharmaceuticalCo.,Ltd.,Beijing102629,China)

ABSTRACT:OBJECTIVETo

evaluate

the

antimicrobial

effectiveness

and

use

of

antimicrobial

agent

of

Levocetirizine

oral

solution,

which

was

included

in

the

national

evalutive

sampling

and

testing

program

in

2021,

and

analyze

the

control

level

of

its

antimicrobial

system

to

microbial

contamination.

METHODSAccording

to

the

method

of

aciclovir

eye

drops

in

Part

II

of

the

2020

edition

of

Chinese

Pharmacopoeia,

the

samples

produced

by

8

manufacturers

were

screened

for

the

types

of

antimicrobial

agent.

Determine

the

content

of

samples

produced

by

6

manufacturers

added

with

antimicrobial

agent

according

to

the

method

provided

by

the

manufacturers.

According

to

General

Rule

1121

of

PartⅣ

of

the

2020

edition

of

the

Chinese

Pharmacopoeia,

evaluate

whether

the

antimicrobial

effe