基于关联规则算法分析中/长链脂肪乳注射液热原检查影响因素研究

Study on Influencing Factors of Pyrogen Examination for Medium/Long Chain Fat Emulsion Injection Based on Association Rule Algorithms

关键词:  热原试验  关联规则  基础体温  使用次数  实验间隔  环境温度

Key words:  pyrogen test  association rule  basic body temperature  frequency of use  experimental interval  ambient temperature

摘要:

目的 探索中/长链脂肪乳注射液热原检查中的不同影响因素对结果的影响，提高中/长链脂肪乳注射液热原检查结果的准确性和可靠性。方法 选取苏州市药品检验检测研究中心近5年对中/长链脂肪乳注射液热原检查的检验数据进行统计，采用Apriori关联规则分析热原实验中家兔升温幅度与家兔体质量、性别、基础体温、环境温度、家兔使用次数、实验样品与前次实验是否相同、实验间隔时间之间的关联关系。结果 家兔升温幅度≥0.4℃与家兔基础体温38.0~38.7℃、环境温度波动1.6~3.0℃、家兔第1~3次使用、实验间隔天数为2~5 d和前次使用相同样品呈现强关联。结论 在中/长链脂肪乳注射液热原检查过程中，应尽量选用基础体温和使用次数不同的家兔，同时尽量避免使用前次样品为中/长链脂肪乳注射液的家兔，实验间隔天数适当延长，并且保持较小环境温度波动，以保证中/长链脂肪乳注射液热原检查的准确性和可靠性。

Abstract:

OBJECTIVE To explore the influence of different influencing factors on the results of pyrogen test for medium/long chain fat emulsion injection, and to improve the accuracy and reliability of pyrogen test results for medium/long chain fat emulsion injection. METHODS The test data of pyrogen test for medium/long chain fat emulsion injection in Suzhou Institute for Drug Control for 5 years were collected and the association between the range of rabbit temperature rise in pyrogen experiment and rabbit weight, sex, basic body temperature, ambient temperature, the number of rabbits used, whether the experimental sample was the same as the previous experiment, and the interval between experiments were analyzed by Apriori association rule. RESULTS "Rabbit temperature rise ≥ 0.4℃" was significantly associated with "basic body temperature 38.0-38.7℃", "ambient temperature fluctuation 1.6-3.0℃", "rabbits were used for 1-3 times", "experimental interval days 2-5 d" and "the same sample was used the previous time". CONCLUSION During the pyrogen test of medium/long chain fat emulsion injection, rabbits with different basic body temperature and use times should be selected as far as possible, and the rabbits using medium/long chain fat emulsion injection in the previous sample should be avoided as far as possible. The experimental interval should be prolonged, and the environmental temperature fluctuation should be maintained to ensure the accuracy and reliability of pyrogen test results for medium/long chain fat emulsion injection.