1.Zishen Tiaogan Prescription Treats Diminished Ovarian Reserve in Rats via Keap1/Nrf2/HO-1 Signaling Pathway
Zhongtong LI ; Yaping ZHANG ; Chen YOU ; Qingqing LI ; Yingjie WANG ; Siwen OU ; Taomei XUE ; Chuqi ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):72-80
ObjectiveTo observe the effect of Zishen Tiaogan prescription on the oxidative stress injury in the rat model of diminished ovarian reserve (DOR) and explore the role of the Kelch-like ECH-associated protein 1 (Keap1)/nuclear factor E2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling pathway. MethodsForty-eight female SD rats were randomly assigned into a normal group (n=12) and a modeling group (n=36). The rats in the modeling group received subcutaneous injection of galactose (350 mg·kg-1) combined with immobilization stress daily. After 28 days of modeling, 6 rats in the normal group and 6 rats in the modeling group were sacrificed to examine the modeling results. The successfully modeled rats were assigned into model, estradiol valerate (0.09 mg·kg-1), and low-, medium-, and high-dose (6.39, 12.78, 25.56 g·kg-1, respectively) Zishen Tiaogan prescription groups. The intervention lasted for 4 weeks with 6 animals per group. Hematoxylin-eosin staining was used to observe the estrous cycle and the pathological changes in the ovarian tissue. The ovarian index was calculated. Enzyme-linked immunosorbent assay was employed to measure the serum levels of sex hormones and oxidative stress-related indexes. Western blot and real-time PCR were employed to determine the protein and mRNA levels, respectively, of Nrf2, Keap1 and HO-1 in the ovarian tissue. The positive expression of superoxide dismutase 2 (SOD2) in the ovarian tissue was detected by immunohistochemistry (IHC). ResultsCompared with the normal group, the model group showed reduced follicles in the ovary, loose arrangement of the follicle granule layer, declined levels of anti-Mullerian hormone (AMH) and estradiol (E2) in the serum, elevated levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) (P<0.01), lowered levels of superoxide dismutase (SOD), catalase (CAT), and glutathione (GSH) (P<0.01), and increased accumulation of malondialdehyde (MDA) (P<0.01). In addition, the modeling led to up-regulated protein and mRNA levels of Keap1 (P<0.01), the expression of Nrf2 and HO-1 protein was significantly decreased (P<0.01), the mRNA expression of Nrf2 was significantly decreased (P<0.05), the mRNA expression of HO-1 was significantly decreased (P<0.01), in the ovarian tissue. Compared with model group, the estradiol valerate and low-, medium-, and high-dose Zishen Tiaogan prescription groups showed increases in the ovarian index (P<0.01) and serum E2 and AMH levels (P<0.01), declined levels of FSH and LH (P<0.01), increased follicles in the ovary, elevated levels of SOD, CAT, and GSH, and reduced accumulation of MDA (P<0.05, P<0.01). Furthermore, these groups showcased down-regulated protein and mRNA levels of Keap1 (P<0.01), the expression of Nrf2 protein was significantly increased (P<0.01), the expression level of HO-1 protein was increased (P<0.05,P<0.01), and increased positive expression of SOD2 (P<0.01). ConclusionZishen Tiaogan prescription can regulate the serum levels of hormones, down-regulate the expression of Keap1, up-regulate the expression of Nrf2, HO-1, and SOD2, enhance the antioxidant capacity, and reduce the peroxidation damage in the ovarian tissue to improve the ovarian reserve function in the rat model of DOR. High-dose Zishen Tiaogan prescription demonstrated the best effect and the mechanism is associated with the regulation of the Keap1/Nrf2/HO-1 pathway.
2.Zishen Tiaogan Prescription Treats Diminished Ovarian Reserve in Rats via Keap1/Nrf2/HO-1 Signaling Pathway
Zhongtong LI ; Yaping ZHANG ; Chen YOU ; Qingqing LI ; Yingjie WANG ; Siwen OU ; Taomei XUE ; Chuqi ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):72-80
ObjectiveTo observe the effect of Zishen Tiaogan prescription on the oxidative stress injury in the rat model of diminished ovarian reserve (DOR) and explore the role of the Kelch-like ECH-associated protein 1 (Keap1)/nuclear factor E2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling pathway. MethodsForty-eight female SD rats were randomly assigned into a normal group (n=12) and a modeling group (n=36). The rats in the modeling group received subcutaneous injection of galactose (350 mg·kg-1) combined with immobilization stress daily. After 28 days of modeling, 6 rats in the normal group and 6 rats in the modeling group were sacrificed to examine the modeling results. The successfully modeled rats were assigned into model, estradiol valerate (0.09 mg·kg-1), and low-, medium-, and high-dose (6.39, 12.78, 25.56 g·kg-1, respectively) Zishen Tiaogan prescription groups. The intervention lasted for 4 weeks with 6 animals per group. Hematoxylin-eosin staining was used to observe the estrous cycle and the pathological changes in the ovarian tissue. The ovarian index was calculated. Enzyme-linked immunosorbent assay was employed to measure the serum levels of sex hormones and oxidative stress-related indexes. Western blot and real-time PCR were employed to determine the protein and mRNA levels, respectively, of Nrf2, Keap1 and HO-1 in the ovarian tissue. The positive expression of superoxide dismutase 2 (SOD2) in the ovarian tissue was detected by immunohistochemistry (IHC). ResultsCompared with the normal group, the model group showed reduced follicles in the ovary, loose arrangement of the follicle granule layer, declined levels of anti-Mullerian hormone (AMH) and estradiol (E2) in the serum, elevated levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) (P<0.01), lowered levels of superoxide dismutase (SOD), catalase (CAT), and glutathione (GSH) (P<0.01), and increased accumulation of malondialdehyde (MDA) (P<0.01). In addition, the modeling led to up-regulated protein and mRNA levels of Keap1 (P<0.01), the expression of Nrf2 and HO-1 protein was significantly decreased (P<0.01), the mRNA expression of Nrf2 was significantly decreased (P<0.05), the mRNA expression of HO-1 was significantly decreased (P<0.01), in the ovarian tissue. Compared with model group, the estradiol valerate and low-, medium-, and high-dose Zishen Tiaogan prescription groups showed increases in the ovarian index (P<0.01) and serum E2 and AMH levels (P<0.01), declined levels of FSH and LH (P<0.01), increased follicles in the ovary, elevated levels of SOD, CAT, and GSH, and reduced accumulation of MDA (P<0.05, P<0.01). Furthermore, these groups showcased down-regulated protein and mRNA levels of Keap1 (P<0.01), the expression of Nrf2 protein was significantly increased (P<0.01), the expression level of HO-1 protein was increased (P<0.05,P<0.01), and increased positive expression of SOD2 (P<0.01). ConclusionZishen Tiaogan prescription can regulate the serum levels of hormones, down-regulate the expression of Keap1, up-regulate the expression of Nrf2, HO-1, and SOD2, enhance the antioxidant capacity, and reduce the peroxidation damage in the ovarian tissue to improve the ovarian reserve function in the rat model of DOR. High-dose Zishen Tiaogan prescription demonstrated the best effect and the mechanism is associated with the regulation of the Keap1/Nrf2/HO-1 pathway.
3.Establishment and application of evaluation criteria for rational use of pyrotinib
Yiyi LIAO ; Xin LI ; Yaowen XIA ; Hongmei ZHAO ; Qingqing CHEN
China Pharmacy 2025;36(6):742-747
OBJECTIVE To establish drug utilization evaluation (DUE) criteria for pyrotinib to promote its appropriate application in clinical practice. METHODS Based on the label of Pyrotinib maleate tablets, with relevant guiding principles and diagnostic and treatment guidelines as the evaluation basis, DUE criteria for pyrotinib were determined through the Delphi method. Attribute hierarchical model (AHM) and entropy weight method (EWM) were used to combine and assign weights to each indicator within the DUE criteria. Additionally, the weighted technique for order preference by similarity to an ideal solution (TOPSIS) method was applied to perform rationality evaluation of medication in archived medical records from Hainan Provincial Tumor Hospital and Hainan Western Central Hospital regarding the use of pyrotinib from November 2019 to November 2023. RESULTS The established DUE criteria for pyrotinib included 4 primary indicators (prescription authority, indications for use, medication process, and medication outcomes) and 11 secondary indicators. The secondary indicators with higher weights were the route of administration and dosage (0.257) and indications in the label (0.241). Among the 88 archived cases included, there were 28 cases of inappropriate medication (31.82%), 43 cases of generally appropriate medication (48.86%), and 17 cases of appropriate medication (19.32%). The main issues related to inappropriate medication involved off-label use (42.05%) and inappropriate routes of administration and dosage (43.18%). CONCLUSIONS DUE criteria for pyrotinib established using the AHM-EWM-weighted TOPSIS method is highly operational and results in quantifiable evaluation outcomes. The overall rationality of the use of pyrotinib in the above hospitals remains to be improved, and there are some issues, like the off-label use,and inappropriate routes of administration and dosage being liaoyylyy@163.com unreasonable.
4.Study on the epidemiological characteristics and influencing factors of long COVID among previously infected individuals in two communities in Shanghai
Junhong YUE ; Chen CHEN ; Qingqing JIA ; Xiaoxia LIU ; Huiting WANG ; Fei WU ; Yanlu YIN ; Jiajie ZANG ; Yanfei GUO ; Fan WU
Shanghai Journal of Preventive Medicine 2025;37(7):597-605
ObjectiveTo analyze the epidemiological characteristics of long COVID and to investigate its main influencing factors by examining individuals infected with SARS-CoV-2 between March and June 2022 in two communities in Shanghai, to lay the foundation for further research on the mechanism and clinical treatment of long COVID, and to provide the basis for the development of inexpensive, convenient, and feasible prevention and intervention strategies. MethodsA cross-sectional study was conducted, enrolling 6 410 individuals infected with SARS-CoV-2. Data were collected through a questionnaire survey. The incidence and common symptoms of long COVID were analyzed, along with their associations with demographic characteristics, medical history, and behavioral factors. A logistic regression model was used to identify the major factors associated with the development of long COVID symptoms. ResultsThe overall incidence rate of long COVID among the study population was 13.9%. The most commonly reported symptoms included fatigue (65.1%), attention disorders (23.1%), and cough (16.9%). The analysis showed that having underlying chronic diseases (OR=2.580, 95%CI: 2.165‒3.074), a history of allergies (OR=1.418, 95%CI: 1.003‒1.971), current smoking (OR=1.461, 95%CI: 1.013‒2.079), ever smoking (OR=2.462, 95%CI: 1.687‒3.551), a greater number of symptoms during the acute phase [1 symptom (OR=1.778, 95%CI: 1.459‒2.162), 2 symptoms (OR=2.749, 95%CI: 2.209‒3.409), ≥3 symptoms (OR=7.792, 95%CI: 6.333‒9.593)] and aggravated symptoms during the acute phase (OR=1.082, 95%CI: 1.070‒1.094) were factors associated with a higher risk of developing long COVID symptoms. Additionally, individuals who had consumed alcohol in the past year (OR=1.914, 95%CI: 1.344‒2.684) were more prone to objective long COVID symptoms. Among individuals under 50 years of age, females (OR=1.427, 95%CI: 1.052‒1.943) were more likely to develop objective long COVID symptoms. ConclusionThis study has identified the diversity of long COVID symptoms, which involve multiple organs and systems, including fatigue, attention disorders, cough, and joint pain. It has also revealed associations between long COVID and various demographic factors (e.g., age, gender), personal medical history (e.g., underlying chronic diseases, history of allergies), acute-phase characteristics (e.g., number and severity of symptoms), and behavioral factors (e.g., smoking, alcohol consumption). These findings highlight the need for further research and ongoing surveillance of long COVID and may inform the development of more targeted health management strategies for specific populations.
5.Association between the Non-Fasting Triglyceride-Glucose Index and Hyperglycemia in pregnancy during the Third Trimester in High Altitudes
Qingqing WANG ; Hongying HOU ; Ma NI ; Yating LIANG ; Xiaoyu CHEN ; WA Zhuoga DA ; Qiang LIU ; Zhenyan HAN
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(5):861-871
ObjectiveTo investigate the relationship between the non-fasting triglyceride and glucose (TyG) index and hyperglycemia in pregnancy during the third trimester in high altitudes. MethodsThis study selected clinical and laboratory data of 774 Tibetan singleton pregnant women who delivered at Chaya People's Hospital of Qamdo city in Xizang autonomous region, from January 2023 to April 2025. The non-fasting TyG index was calculated from non-fasting triglyceride (TG) and random plasma glucose (PG). Based on the tertiles of the non-fasting TyG index values, the individuals were split into three groups (corresponding to non-fasting TyG index of 8.89 and 9.21, respectively). The baseline clinical characteristics, lipid levels and the occurrence of developing hyperglycemia in pregnancy were compared among the three groups. Statistical analyses were performed using ANOVA, Kruskal-Wallis H test, Chi-square test, or Fisher exact test and the relationship between the non-fasting TyG index and hyperglycemia in pregnancy were examined using multivariate logistic regression models and curve fitting. ResultsA total of 774 Tibetan singleton pregnant women were included, with a average age of 27.3 ± 6.1 years, a pre-delivery body mass index (Pre-BMI) of (25.2±2.3)kg/m2 , a proportion of 26.7% (207/774) primigravid women, the mean non-fasting TyG index was 9.1 ± 0.4。Thirty pregnant women were diagnosed with hyperglycemia in pregnancy, with a detection rate of 3.9% (30/774). Statistically significant differences in serum total cholesterol (TC), TG, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels were identified when comparing different non-fasting TyG groups (all P values <0.05). Subsequent trend test analysis indicated that the levels of TC, TG, LDL-C, and PG gradually increased with elevated the non-fasting TyG index ( Ftrend TC=95.61, P<0.001; Ftrend TG=1 051.91, P<0.001; Ftrend LDL-C = 97.20, P < 0.001; Ftrend TG=195.20; P<0.001). After adjustment for maternal age, pre-delivery BMI, altitude, TC, LDL-C, and HDL-C, multivariate Logistic regression models revealed independent positive associations between non-fasting TyG index and hyperglycemia in pregnancy (Model 1: OR=2.72, 95% CI: 1.13-6.53, P=0.026; Model 2: OR=2.56, 95% CI: 1.01-6.50, P=0.048; Model 3: OR=2.72, 95% CI: 1.06-6.97, P=0.037; Model 4: OR=4.02, 95% CI: 1.42-11.40, P=0.009) and the incident of hyperglycemia in pregnancy showed an increasing tendency as increasing with the non-fasting TyG index, however, this association did not statistical significance (P trend >0.05). Curve fitting by restricted cubic splines (RCS) were used to assess linearity between non-fasting TyG and hyperglycemia in pregnancy, and there was a linear dose-response relationship between non-fasting TyG and hyperglycemia in pregnancy (P for non-linear = 0.515). ConclusionNon-fasting TyG index in the third trimester is a risk factor for hyperglycemia in pregnancy among the Tibetan singleton pregnant women at high altitudes and there was a possible linear dose-response relationship between the non-fasting TyG index and hyperglycemia in pregnancy.
6.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
7.Herbal Textual Research on Olibanum in Famous Classical Formulas
Haiyan ZHOU ; Qingqing WANG ; Qi ZHANG ; Suping XIAO ; Meng CHEN ; Jianxin ZHOU ; Yeda ZHANG ; Danyang JIA ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):55-66
By consulting the ancient and moderm literature, this paper makes a textual research on the name, origin, quality evaluation, harvesting and processing of Olibanum, so as to provide a basis for the development of the famous classical formulas containing this medicinal material. According to the herbal textual research, the results showed that Olibanum was first described as a medicinal material by the name of Xunluxiang in Mingyi Bielu(《名医别录》), until Ruxiang had been used as the correct name since Bencao Shiyi(《本草拾遗》) in Tang dynasty. The main origin was Boswellia carterii from Burseraceae family. The mainly producing areas in ancient description were ancient India and Arabia, while the modern producing areas are Somalia, Ethiopia and the southern Arabian Peninsula. The medicinal part of Olibanum in ancient and modern times is the resin exuded from the bark, which has been mainly harvested in spring and summer. It is concluded that the better Olibanum has light yellow, granular, translucent, no impurities such as sand and bark, sticky powder and aromatic smell. There were many processing methods in ancient times, including cleansing(water flying, removing impurities), grinding(wine grinding, rush grinding), frying(stir-frying, rush frying, wine frying), degreasing, vinegar processing, decoction. In modern times, the main processing methods are simplified to cleansing, stir-frying and vinegar processing. Nowadays, the commonly used specifications include raw, fried and vinegar-processed products. Among the three specifications, raw products is the Olibanum after cleansing, fried products is a kind of Olibanum processed by frying method, vinegar-processed products is the processed products of pure frankincense mixed with vinegar. Based on the research results, it is recommended to select the resin exuded from the bark of B. carterii for the famous classical formulas such as Juanbitang containing Olibanum, processing method should be carried out in accordance with the processing requirements of the formulas, otherwise used the raw products if the formulas without clear processing requirements.
8.Establishment and verification of microscopic review rules in Dirui GMD-S600 gynecological secretion analysis system
Wanchao LIU ; Longmei CHEN ; Liangxiao ZHU ; Qingqing LIU ; Yiqiao DU
International Journal of Laboratory Medicine 2024;45(2):229-233
Objective To establish and verify the microscopic review rules of Dirui GMD-S600 gynecologi-cal secretion analysis system.Methods A total of 2 619 samples of vaginal secretions were collected and test-ed for tangible components and dry chemistry items using the Dirui GMD-S600 gynecological secretions analy-sis system.All samples were subjected to manual microscope examination using a double blind method,and the results of instrument testing,manual image review of instrument testing,and manual microscope examina-tion were recorded separately.Using the results of manual microscope examination as the standard,the false negative rates and the false positive rates of instrument testing results and tangible component results after manual image review of instrument testing were analyzed.At the same time,the false negative rates and the false positive rates of instrument detection dry chemistry items and their corresponding tangible components were analyzed,and the review rules were derived based on this.Subsequently,344 samples were selected to verify the effectiveness of the review rules.Results The false positive rates of white blood cells,fungi,trichomonas and clue cells detected by the instrument were 28.77%,14.71%,20.09%and 2.30%,and the false negative rates were 0.28%,15.06%,4.35%and 10.34%.After manual image review and correction,the false positive rates of white blood cells,fungi,trichomonas and clue cells were 28.77%,7.06%,8.67%,0.66%,and the false negative rates were 0.28%,3.35%,4.35%and 10.34%.The false positive rates of white blood cell esterase(LE)for white blood cells,N-acetylhexylglucosidase(NAG)for fungi,NAG for trichomonas,hydrogen peroxide(H2O2)for bacteria,lactic acid(LA)for bacteria,sialidase(SNA)for clue cells,and proline aminopeptidase(PIP)for clue cells were 13.83%,22.47%,24.10%,95.52%,2.52%,12.92%and 5.54%,and the false negative rates were 28.17%,48.12%,0.00%,23.55%,78.82%,0.00%and 74.14%.The false positive rate of 260 validation samples was 1.68%,the false negative rate was 4.22%,and the review rate was 45.38%.Conclusion The review rules of the Dirui GMD-S600 gynecological secretion analysis system are as follows(1)All specimens need to be reviewed with images,and the following rules are based on this rule.(2)When the result of white blood cell shows positive,then the microscopic exam-ination is required.(3)When the result of fungi shows positivity,then the microscopic examination is re-quired.(4)When the result of trichomonas shows positive,then the microscopic examination is required.(5)When the result of SNA does not match the positive result of clue cells,then the microscopic examination is required.
9.Clinical analysis of robotic bilateral modified radical neck dissection through the bilateral axillo-breast approach for thyroid carcinoma
Lanqing CHEN ; Xiaolei LI ; Dayong ZHUANG ; Peng ZHOU ; Tao YUE ; Jing XU ; Sijuan CHEN ; Chenyu LI ; Changxiu SHAO ; Qingqing HE
Chinese Journal of Endocrine Surgery 2024;18(1):21-25
Objective:To research the efficacy and safety of robotic thyroidectomy and bilateral modified radical neck dissection through bilateral axillo-breast approach (BABA) .Methods:We retrospectively analyzed the clinical data of 37 patients with thyroid cancer who received bilateral modified radical neck dissection through the BABA at the Department of Thyroid and Breast Surgery of the 960th Hospital of the People’s Liberation Army from Jan. 2014 to Jan. 2023. There were 24 females and 13 males, and the average age of the patients was (33,22±10.53) years old. The tumor diameter, number of lymph node dissection and metastasis in the central and lateral regions, average operation time, average hospital stay, complications, and aesthetic score were recorded. SPSS 25.0 software was used for statistical analysis, and the measurement data was calculated using mean ± standard deviation ( ± s), and the counting data was expressed in percentages and numbers. Results:A total of 37 thyroid cancer patients underwent robotic bilateral regional lymph node dissection. The 37 patients received total thyroidectomy, bilateral central compartment and cervical lateral regional lymph node dissection. All the pathological types were papillary carcinoma, with a maximal tumor diameter of (1.47±0.85) cm. The average number of central lymph nodes dissected was 19.46±8.84, and there were (10.24±5.95) metastases; The average number of lymph nodes removed from the bilateral cervical region was 38.92±14.21, and there were (7.92±5.84) metastases. The average operation time was (288.05±77.09) min, the average length of stay in the hospital was (10.76±3.92) days, and the average length of stay in the hospital following surgery was (8.03±2.08) days. These patients had no permanent hypoparathyroidism, permanent recurrent laryngeal nerve palsy, infection, accessory nerve injury and phrenic nerve injury after operation. Transient hypoparathyroidism occurred in 15 patients, transient recurrent laryngeal nerve palsy occurred in 1 patient, and chyle leak occurred in 2 patients. One month after surgery, the aesthetic score was 9.51±0.69.Two patients were found lymph node metastases during the (27.81±15.10) months of follow-up, and received robotic cervical lymph node dissection with BABA.Conclusion:For carefully chosen thyroid cancer patients with bilateral lateral cervical region lymph node metastases, robotic bilateral cervical lymph node regional dissection via BABA is safe and feasible, and good cosmetic results can be obtained.
10.Study on Optimization of spray Drying Process of Banlangen Formula Granules
Lanlan ZHANG ; Wenting SHI ; Weimei CHEN ; Zan YANG ; Xingpeng HUANG ; Qingqing TIAN ; Zheng ZHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):202-210
Objective To optimize the spray drying process of Banlangen(Isatidis Radix)formula granules based on quality by design(QbD)concept.Methods Using powder yield and the contents of uridine,adenosine,guanosine,and(R,S)-goitron as the critical quality attributes(CQAs),Plackett-Burman design was used to screen out critical process parameters(CPPs)for inlet temperature,spray pressure,liquid temperature,pump speed,and liquid relative density.The central-composite design(CCD)test was used to optimize the CPPs,which were screened.Based on the quadratic polynomial regression model,the design space of spray drying process of Banlangen(Isatidis Radix)formula granules was established,and further validated by experiments.Results Plackett-burman test results show that liquid relative density and inlet velocity are the key parameters for the study.The variance analysis results of CCD test showed that the constructed model in a good prediction ability,since the P-values of model was less than 0.01 and P-values of items lack of fit was more than 0.05.The optimized design space of CPPs was the liquid relative density 1.05-1.08,and pump speed 30%-40%.Conclusion Based on the QbD concept,the design space for the spray drying process of Banlangen(Isatidis Radix)formula granules can improve the stability of its process and help ensure the consistency of product quality.

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