1.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
2.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
6.Herbal Textual Research on Kochiae Fructus in Famous Classical Formulas
Huifang HU ; Liping YANG ; Fei CHEN ; Xiaohui MA ; Ling JIN ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):247-257
In this paper, by referring to ancient and modern literature, the textual research of Kochiae Fructus has been conducted to clarify the name, origin, distribution of production areas, quality specification, taste and efficacy, harvesting time, processing and compatibility taboo, so as to provide reference and basis for the development and utilization of related famous classical formulas. According to the investigation, it can be seen that Difuzi was first published in Sheng Nong's Herbal Classic, and has been used as the official name throughout history. It is also known by other names such as Dimai, Dikui, and Luozhou. The mainstream source of Difuzi in materia medica throughout history is the dried ripe fruit of Kochia scoparia, which is consistent throughout history. In the Han dynasty, it was recorded that Kochiae Fructus was produced in Jingzhou(Hubei province), while modern literature records its distribution throughout the country, so it does not have obvious geoherbalism. The harvesting period of Kochiae Fructus is mostly in the late autumn, and the quality is best when it is full, gray green in color, and no impurities. There are two processing methods for its origin:from the Southern and Northern dynasties to the Ming dynasty, it was dried in the shade, and after the founding of the People's Republic of China, it was dried in the sun. There are few records about the processing of Kochiae Fructus, and its clinical application is mostly based on raw products as medicine. The seedlings are harvested in February of the lunar calendar, and the leaves are taken in April and May, processing in the place of origin is shade drying, the processing methods include burning ash and frying frost, pounding juice and wine soaking. For internal use, it is mostly decocted or mashed, while for external use, it is mostly washed with decoction or taken in a soup bath. Throughout history, it has been recorded that Kochiae Fructus is bitter and cold, and is mainly used for treating bladder fever. After the founding of the People's Republic of China, most of the literature classified it as damp-clearing medicine. Since the 1985 edition of Chinese Pharmacopoeia, it has been recorded that Kochiae Fructus has a pungent and bitter taste, and a cold nature. Returning to the kidney and bladder meridians with functions of clearing heat and dampness, dispelling wind and relieving itching. The clinical contraindications are mainly prohibited for those with deficiency and no dampness and heat. Throughout history, it has been recorded that the taste of the seedlings and leaves is bitter and cold for treatment of dysentery. Since modern times, it has been used to regulate the liver, spleen and large intestine meridians, with functions such as clearing heat and detoxifying, and diuresis. Based on the textual research, it is recommended to use the dried ripe fruit of K. scoparia when developing the famous classical formulas containing Kochiae Fructus, and processing shall be carried out according to the original processing requirements. If the original formula does not specify the processing requirements, the raw products is taken into medicine.
7.Herbal Textual Research on Cnidii Fructus in Famous Classical Formulas
Huifang HU ; Liping YANG ; Fei CHEN ; Xiaohui MA ; Ling JIN ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):243-253
In this paper, by referring to ancient and modern literature, the textual research of Cnidii Fructus has been conducted to clarify the name, origin, distribution of production areas, quality specification, nature and flavour, efficacy, harvesting and processing, compatibility taboo and others, so as to provide reference and basis for the development and utilization of the relevant famous classical formulas. After textual research, it can be verified that Cnidii Fructus was first published in Sheng Nong's Herbal Classic, the materia medica of all dynasties was named Shechuangzi, and there are also aliases such as Shesu, Shemi, and Qiangmi. The main source for generations was the dried ripe fruit of Cnidium monnieri, and ancient and modern consistent. From the Eastern Han dynasty to Tang dynasty, the origin of Cnidii Fructus was Zibo, Shandong province. During the Five dynasties, it expanded to Yangzhou in Jiangsu province and Xiangyang in Hubei province, the Song dynasty added Shangqiu in Henan province, and it was considered that Yangzhou, Xiangyang and Shangqiu were its genuine producing areas. It was more widely distributed in Ming and Qing dynasties. After the founding of the People's Republic of China, the origin is clearly distributed throughout the country. For its quality evaluation, generally full grain, gray yellow color, strong aroma is the best. The harvesting period in the past dynasties was mostly the fifth lunar month, and the fruit was collected to remove impurities and dry. The mainstream processing in producing area of the past dynasties was net selection of raw products, mixing and steaming with the juice of Rehmanniae Radix and stir-frying were the mainstream processing methods in the past, there were also stir-frying with honey, stir-frying with salt and rice wine, immersing and steaming with rice wine and other methods. In recent times, it has been used in raw products as medicine. Sheng Nong's Herbal Classic recorded Cnidii Fructus was bitter, Supplementary Records of Famous Physicians recorded its acrid for the first time. It was recorded in the Ming dynasty that its nature was warm, acted on the kidney meridian, and had small toxicity. After the founding of the People's Republic of China, most of the literature classified it as a medicine to attack poison, kill insects and relieve itching with the functions of dispelling pathogenic wind and removing dampness, destroying parasites and elieving itching, warming kidney and activating Yang. Clinical contraindications are mainly contraindicated for people with damp-heat from the lower-jiao or kidney heat. Based on the textual research, it is suggested that when developing the famous classical formulas containing Cnidii Fructus, the source shall be the dried ripe fruit of C. monnieri, and then it shall be processed according to the original formulas. If there is no requirement for processing in the formulas, the raw products can be taken into medicine.
8.Effect of depth of neuromuscular blockade on hepatic perfusion and liver function in patients undergoing laparoscopic hepatectomy
Shi-Lai WANG ; Fei CAI ; Hu LYU ; Jun ZHANG ; Wei CHEN
Fudan University Journal of Medical Sciences 2024;51(1):56-61
Objective To investigate deep neuromuscular blockade(NMD)and moderate NMD on hepatic perfusion and liver function during laparoscopic hepatectomy.Methods A total of 60 patients who received laparoscopic hepatectomy in Fudan University Shanghai Cancer Center were recruited from Dec 2021 to Dec 2022.They were randomly divided into two groups:deep NMD group(D group,n=30)and moderate NMD group(M group,n=30).D group was induced by administration of rocuronium 0.9 mg/kg followed by continuous infusion to maintain intraoperative post-tetanic count(PTC)of 1-2,while M group was induced by administration of rocuronium 0.6 mg/kg followed by continuous infusion to maintain intraoperative train-of-four(TOF)of 1-2.Indocyanine green(ICG)of 0.25 mg/kg was given intravenously both after induction and after specimen excision,and retention rate at fifteen minutes(ICGR15)was recorded.In addition,intraoperative rocuronium dosage,surgical operation satisfaction score,postoperative shoulder pain,and the occurrence of vomiting on postoperative day 1(POD1)were also recorded.Results Compared with M group,the dosage of rocuronium in D group was significantly increased(P<0.01),but there was no difference of ICGR15 between the two groups(P=0.581),even other parameters of perioperative liver function.The surgical operation satisfaction score was significantly higher(P<0.05),while the postoperative shoulder pain(P=0.037,OR=1.37,95%CI:1.01-1.86)and the occurrence of vomiting on POD1(P=0.017,OR=1.64,95%CI:1.07-2.53)were significantly lower in D group than those in M group.Conclusion Compared with moderate NMB,deep NMB can significantly improve surgery condition,reduce postoperative shoulder pain and vomiting.However,there was no significant difference between them on the hepatic perfusion and perioperative liver function.
9.Feasibility of automatic segmentation of CTV and OARs in postoperative radiotherapy for cervical cancer using AccuLearning
Fei CHEN ; Xiaoqin GONG ; Yunpeng YU ; Tao YOU ; Xu WANG ; Chunhua DAI ; Jing HU
The Journal of Practical Medicine 2024;40(2):153-157
Objective To explore the feasibility of automatic segmentation of clinical target volume(CTV)and organs at risk(OARs)for cervical cancer using AccuLearning(AL)based on geometric and dosimetric indices.Methods Seventy-five CT localization images with manual contouring data of postoperative cervical cancer were enrolled in this study.Sixty cases were randomly selected to trained to generate automatic segmentation model by AL,and the CTV and OARs of the remaining 15 cases were automatically contoured.Radiotherapy plans on the automatic segmentation contours were imported on the CT images of manual contours.The efficiency,Dice similarity coefficient(DSC),Hausdorff distance(HD)and dosimetric parameters were compared between the two methods.Results The time of automatic segmentation was significantly shorter than that of the manual contour(P<0.05).The DSC of all structures were≥0.87.The HD of bowel bag and rectum were about 10 mm,and that of the rest of OARs were less than 5 mm.CTV(D98,V90% ,V95% ,Dmean,HI),bowel bag(V50)and bladder(V50)had significant differences in dosimetric comparison(P<0.05).Conclusion The automatic segmentation model based on AL can improve the efficiency of radiotherapy.Automatic segmentation of OARs has the potential of clinical application,while that of CTV still needs to be further modified.
10.Analysis of dosimetric parameters of acute radiation enteritis in cervical cancer patients treated with con-current chemoradiotherapy
Jing HU ; Xu WANG ; Xiaoqin GONG ; Rui LING ; Tao YOU ; Chunhua DAI ; Ye TIAN ; Fei CHEN
The Journal of Practical Medicine 2024;40(5):672-676
Objective To explore the correlation between intestinal dose and acute radiation enteritis(ARE)in patients with cervical cancer received concurrent chemoradiotherapy,and optimize the dose limit of intestinal tissue.Methods 158 cervical cancer patients received concurrent chemoradiotherapy from 2014 to 2019 were selected in this study.According to CTCAE 5.0,patients with ARE≥grade 2 were classified as ARE≥grade 2 group,otherwise classified as ARE

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