The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective:To investigate the therapeutic effectiveness and related factors of fertility preservation therapy(referred to as conservation therapy)using Levonorgestre-releasing intrauterine system(LNG-IUS)com-bined with Metformin in patients with atypical endometrial hyperplasia and early endometrial cancer.Methods:A retrospective analysis was conducted on the clinical data of 41 patients with atypical endometrial hyperplasia and 11 patients with early endometrial cancer who required fertility preservation therapy and admitted to Shenyang Women and Children's Hospital from January 1,2015 to December 30,2021.According to different treatment methods,they were divided into a study group(26 cases,LNG-IUS+metformin)and a control group(26 cases,high efficiency progesterone+metformin).Regularly review endometrial pathology and analyze the differences in complete remission rate,recurrence rate,and pregnancy outcomes between the two groups.Univariate Logistic regression was used to analyze the factors affecting complete remission,recurrence,and pregnancy outcomes in those patients.Results:There was no statistically significant difference in general clinical data between the two groups(P＞0.05).Compared with the control group,the study group had higher complete remission rate,shorter average complete remission time,less recurrence rate,and higher live birth rate,with a statistically significant be-tween the two groups(P＜0.05).Logistic regression analysis found that body mass index(BMI)≥30 kg/m2was a risk factor for complete remission(P＜0.05);BMI ≥30 kg/m2 and patients with diabetes or insulin resistance were the risk factors for recurrence after treatment(P＜0.05);BMI≥30 kg/m2 and diseases associated with fe-male reproductive system were the risk factors for pregnancy after preserving fertility therapy(P＜0.05).Conclu-sions:LNG-IUS combined with metformin has a more satisfactory therapeutic effect and pregnancy outcomes,compared to high efficiency progesterone combined with metformin in preserving fertility therapy.At the same time,BMI＜30 kg/m2 can increase the complete remission rate,reduce the recurrence rate after cure,and in-crease the pregnancy rate after preserving fertility therapy.

Objective:To investigate the therapeutic effectiveness and related factors of fertility preservation therapy(referred to as conservation therapy)using Levonorgestre-releasing intrauterine system(LNG-IUS)com-bined with Metformin in patients with atypical endometrial hyperplasia and early endometrial cancer.Methods:A retrospective analysis was conducted on the clinical data of 41 patients with atypical endometrial hyperplasia and 11 patients with early endometrial cancer who required fertility preservation therapy and admitted to Shenyang Women and Children's Hospital from January 1,2015 to December 30,2021.According to different treatment methods,they were divided into a study group(26 cases,LNG-IUS+metformin)and a control group(26 cases,high efficiency progesterone+metformin).Regularly review endometrial pathology and analyze the differences in complete remission rate,recurrence rate,and pregnancy outcomes between the two groups.Univariate Logistic regression was used to analyze the factors affecting complete remission,recurrence,and pregnancy outcomes in those patients.Results:There was no statistically significant difference in general clinical data between the two groups(P＞0.05).Compared with the control group,the study group had higher complete remission rate,shorter average complete remission time,less recurrence rate,and higher live birth rate,with a statistically significant be-tween the two groups(P＜0.05).Logistic regression analysis found that body mass index(BMI)≥30 kg/m2was a risk factor for complete remission(P＜0.05);BMI ≥30 kg/m2 and patients with diabetes or insulin resistance were the risk factors for recurrence after treatment(P＜0.05);BMI≥30 kg/m2 and diseases associated with fe-male reproductive system were the risk factors for pregnancy after preserving fertility therapy(P＜0.05).Conclu-sions:LNG-IUS combined with metformin has a more satisfactory therapeutic effect and pregnancy outcomes,compared to high efficiency progesterone combined with metformin in preserving fertility therapy.At the same time,BMI＜30 kg/m2 can increase the complete remission rate,reduce the recurrence rate after cure,and in-crease the pregnancy rate after preserving fertility therapy.

Objective:To investigate the therapeutic effectiveness and related factors of fertility preservation therapy(referred to as conservation therapy)using Levonorgestre-releasing intrauterine system(LNG-IUS)com-bined with Metformin in patients with atypical endometrial hyperplasia and early endometrial cancer.Methods:A retrospective analysis was conducted on the clinical data of 41 patients with atypical endometrial hyperplasia and 11 patients with early endometrial cancer who required fertility preservation therapy and admitted to Shenyang Women and Children's Hospital from January 1,2015 to December 30,2021.According to different treatment methods,they were divided into a study group(26 cases,LNG-IUS+metformin)and a control group(26 cases,high efficiency progesterone+metformin).Regularly review endometrial pathology and analyze the differences in complete remission rate,recurrence rate,and pregnancy outcomes between the two groups.Univariate Logistic regression was used to analyze the factors affecting complete remission,recurrence,and pregnancy outcomes in those patients.Results:There was no statistically significant difference in general clinical data between the two groups(P＞0.05).Compared with the control group,the study group had higher complete remission rate,shorter average complete remission time,less recurrence rate,and higher live birth rate,with a statistically significant be-tween the two groups(P＜0.05).Logistic regression analysis found that body mass index(BMI)≥30 kg/m2was a risk factor for complete remission(P＜0.05);BMI ≥30 kg/m2 and patients with diabetes or insulin resistance were the risk factors for recurrence after treatment(P＜0.05);BMI≥30 kg/m2 and diseases associated with fe-male reproductive system were the risk factors for pregnancy after preserving fertility therapy(P＜0.05).Conclu-sions:LNG-IUS combined with metformin has a more satisfactory therapeutic effect and pregnancy outcomes,compared to high efficiency progesterone combined with metformin in preserving fertility therapy.At the same time,BMI＜30 kg/m2 can increase the complete remission rate,reduce the recurrence rate after cure,and in-crease the pregnancy rate after preserving fertility therapy.

Objective:To investigate the therapeutic effectiveness and related factors of fertility preservation therapy(referred to as conservation therapy)using Levonorgestre-releasing intrauterine system(LNG-IUS)com-bined with Metformin in patients with atypical endometrial hyperplasia and early endometrial cancer.Methods:A retrospective analysis was conducted on the clinical data of 41 patients with atypical endometrial hyperplasia and 11 patients with early endometrial cancer who required fertility preservation therapy and admitted to Shenyang Women and Children's Hospital from January 1,2015 to December 30,2021.According to different treatment methods,they were divided into a study group(26 cases,LNG-IUS+metformin)and a control group(26 cases,high efficiency progesterone+metformin).Regularly review endometrial pathology and analyze the differences in complete remission rate,recurrence rate,and pregnancy outcomes between the two groups.Univariate Logistic regression was used to analyze the factors affecting complete remission,recurrence,and pregnancy outcomes in those patients.Results:There was no statistically significant difference in general clinical data between the two groups(P＞0.05).Compared with the control group,the study group had higher complete remission rate,shorter average complete remission time,less recurrence rate,and higher live birth rate,with a statistically significant be-tween the two groups(P＜0.05).Logistic regression analysis found that body mass index(BMI)≥30 kg/m2was a risk factor for complete remission(P＜0.05);BMI ≥30 kg/m2 and patients with diabetes or insulin resistance were the risk factors for recurrence after treatment(P＜0.05);BMI≥30 kg/m2 and diseases associated with fe-male reproductive system were the risk factors for pregnancy after preserving fertility therapy(P＜0.05).Conclu-sions:LNG-IUS combined with metformin has a more satisfactory therapeutic effect and pregnancy outcomes,compared to high efficiency progesterone combined with metformin in preserving fertility therapy.At the same time,BMI＜30 kg/m2 can increase the complete remission rate,reduce the recurrence rate after cure,and in-crease the pregnancy rate after preserving fertility therapy.

Objective:To investigate the therapeutic effectiveness and related factors of fertility preservation therapy(referred to as conservation therapy)using Levonorgestre-releasing intrauterine system(LNG-IUS)com-bined with Metformin in patients with atypical endometrial hyperplasia and early endometrial cancer.Methods:A retrospective analysis was conducted on the clinical data of 41 patients with atypical endometrial hyperplasia and 11 patients with early endometrial cancer who required fertility preservation therapy and admitted to Shenyang Women and Children's Hospital from January 1,2015 to December 30,2021.According to different treatment methods,they were divided into a study group(26 cases,LNG-IUS+metformin)and a control group(26 cases,high efficiency progesterone+metformin).Regularly review endometrial pathology and analyze the differences in complete remission rate,recurrence rate,and pregnancy outcomes between the two groups.Univariate Logistic regression was used to analyze the factors affecting complete remission,recurrence,and pregnancy outcomes in those patients.Results:There was no statistically significant difference in general clinical data between the two groups(P＞0.05).Compared with the control group,the study group had higher complete remission rate,shorter average complete remission time,less recurrence rate,and higher live birth rate,with a statistically significant be-tween the two groups(P＜0.05).Logistic regression analysis found that body mass index(BMI)≥30 kg/m2was a risk factor for complete remission(P＜0.05);BMI ≥30 kg/m2 and patients with diabetes or insulin resistance were the risk factors for recurrence after treatment(P＜0.05);BMI≥30 kg/m2 and diseases associated with fe-male reproductive system were the risk factors for pregnancy after preserving fertility therapy(P＜0.05).Conclu-sions:LNG-IUS combined with metformin has a more satisfactory therapeutic effect and pregnancy outcomes,compared to high efficiency progesterone combined with metformin in preserving fertility therapy.At the same time,BMI＜30 kg/m2 can increase the complete remission rate,reduce the recurrence rate after cure,and in-crease the pregnancy rate after preserving fertility therapy.

Objective:To investigate the therapeutic effectiveness and related factors of fertility preservation therapy(referred to as conservation therapy)using Levonorgestre-releasing intrauterine system(LNG-IUS)com-bined with Metformin in patients with atypical endometrial hyperplasia and early endometrial cancer.Methods:A retrospective analysis was conducted on the clinical data of 41 patients with atypical endometrial hyperplasia and 11 patients with early endometrial cancer who required fertility preservation therapy and admitted to Shenyang Women and Children's Hospital from January 1,2015 to December 30,2021.According to different treatment methods,they were divided into a study group(26 cases,LNG-IUS+metformin)and a control group(26 cases,high efficiency progesterone+metformin).Regularly review endometrial pathology and analyze the differences in complete remission rate,recurrence rate,and pregnancy outcomes between the two groups.Univariate Logistic regression was used to analyze the factors affecting complete remission,recurrence,and pregnancy outcomes in those patients.Results:There was no statistically significant difference in general clinical data between the two groups(P＞0.05).Compared with the control group,the study group had higher complete remission rate,shorter average complete remission time,less recurrence rate,and higher live birth rate,with a statistically significant be-tween the two groups(P＜0.05).Logistic regression analysis found that body mass index(BMI)≥30 kg/m2was a risk factor for complete remission(P＜0.05);BMI ≥30 kg/m2 and patients with diabetes or insulin resistance were the risk factors for recurrence after treatment(P＜0.05);BMI≥30 kg/m2 and diseases associated with fe-male reproductive system were the risk factors for pregnancy after preserving fertility therapy(P＜0.05).Conclu-sions:LNG-IUS combined with metformin has a more satisfactory therapeutic effect and pregnancy outcomes,compared to high efficiency progesterone combined with metformin in preserving fertility therapy.At the same time,BMI＜30 kg/m2 can increase the complete remission rate,reduce the recurrence rate after cure,and in-crease the pregnancy rate after preserving fertility therapy.