1.Consideration and Suggestions on Dosage Labeling Issues in Chinese Patent Medicines Instructions
Juan XU ; Gaiping WANG ; Yu ZHANG ; Lingjun DONG ; Junfei WANG ; Hongfeng LIU ; Weihong CHEN
Herald of Medicine 2025;44(5):720-726
Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60%)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30% lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.
2.Consideration and Suggestions on Dosage Labeling Issues in Chinese Patent Medicines Instructions
Juan XU ; Gaiping WANG ; Yu ZHANG ; Lingjun DONG ; Junfei WANG ; Hongfeng LIU ; Weihong CHEN
Herald of Medicine 2025;44(5):720-726
Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60%)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30% lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.
3.A rapid and accurate method for herpesviral gnome editing.
Aijun SUN ; Xiangru WANG ; Shuaikang YANG ; Ying LIU ; Gaiping ZHANG ; Guoqing ZHUANG
Chinese Journal of Biotechnology 2021;37(4):1376-1384
To rapidly and accurately manipulate genome such as gene deletion, insertion and site mutation, the whole genome of a very virulent strain Md5 of Marek's disease virus (MDV) was inserted into bacterial artificial chromosome (BAC) through homogeneous recombination. The recombinant DNA was electroporated into DH10B competent cells and identified by PCR and restriction fragment length polymorphism analysis. An infectious clone of Md5BAC was obtained following transfection into chicken embryo fibroblast (CEF) cells. Furthermore, a lorf10 deletion mutant was constructed by two step Red-mediated homologous recombination. To confirm the specific role of gene deletion, the lorf10 was reinserted into the original site of MDV genome to make a revertant strain. All the constructs were rescued by transfection into CEF cells, respectively. The successful packaging of recombinant viruses was confirmed by indirect immunofluorescence assay. The results of growth kinetics assay and plaques area measurement showed that the lorf10 is dispensable for MDV propagation in vitro. Overall, this study successfully constructed an infectious BAC clone of MDV and demonstrated its application in genome manipulation; the knowledge gained from our study could be further applied to other hepesviruses.
Animals
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Chick Embryo
;
Chickens
;
Chromosomes, Artificial, Bacterial
;
DNA, Recombinant
;
Herpesvirus 2, Gallid/genetics*
;
Marek Disease
4.Effects of Different Posterior Tibial Slopes in Unicompartmental Knee Arthroplasty on the Wear and Function of Prosthesis
Kunneng WU ; Gaiping ZHAO ; Dongqing LIU ; Shengqi HANG ; Peng LIANG ; Pengxiang LI ; Tong MA ; Yihui TU
Journal of Medical Biomechanics 2021;36(4):E618-E624
Objective To establish the three-dimensional (3D) finite element model of unicompartmental knee arthroplasty (UKA) with 3° and 7° posterior tibial slope at different knee flexion angles, and to study biomechanical properties and prosthetic wear of the knee joints with two types of posterior tibia slope and their effects on knee function. Methods Combining CT and MRI images of human knee joints with the 3rd-generation Oxford prosthesis, the finite element UKA model with 3° and 7° posterior tibia slope were established. The 1 kN load was applied to center point of the medial and lateral condyles of the femur to simulate the standing load of human body. The maximum stresses and distributions of the prosthesis and articular cartilage at different knee flexion angles were analyzed. ResultsThe maximum stress of the meniscus liner with 3° posterior tibia slope at 0°, 30°, 60°, 90°, 120° knee flexion angles increased by 28.06%, 68.99%, 19.45%, 21.06% and 53.38%, the distribution area was concentrated from the side of the meniscus liner to the central area, and the stress concentration was obvious at 120° knee flexion. The maximum stress of prosthesis with 3° posterior tibia slope was greater than that with 7 ° posterior tibia slope. The expansion of stress concentration area would cause wear and loosening of the prosthesis, contact stress and concentration area of the articular cartilage would subsequently increase with posterior tibia slope increasing, and stress concentration would be more obvious at high knee flexion angles. Conclusions Tibial prosthesis has the higher stress and greater wear under the condition of 3° posterior tibia slope than 7° posterior tibia slope. The research findings provide theoretical basis for the UKA design in clinic.
5.Analysis of ophthalmic diseases of crewmen on a certain large surface ship during its navigation and berthing
Xiaojuan LIU ; Gaiping DU ; Zheng JIN
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(4):415-418
Objective:Based on the investigation and analysis of the medical record of the ophthalmic diseases of the crewmen on a certain large surface ship during navigation and berthing, the causes of the diseases were analyzed, so as to provide a basis for the enhancement of ophthalmic medical support for large surface ships.Methods:The outpatient records of the crewmen in the Ophthalmology Department of a certain large surface ship during the navigation (84 d) and berthing (161 d) from January 2018 to August 2019 were reviewed; the incidence rate and proportion of various eye diseases were calculated; and the pathogenetic features, the whole course of diagnosis and treatment, and prognosis were statistically analyzed.Results:The eye diseases of top 6 incidence rate during navigation were conjunctivitis (8.72%), asthenopia (3.42%), xerophthalmia (3.18%), meibomianitis (2.41%), dermatitis of lids (1.00%), and ocular trauma (0.94%); the eye diseases of top 6 incidence rate in the period of berthing were conjunctivitis (8.07%), xerophthalmia (3.65%), asthenopia (3.24%), meibomianitis (2.71%), ocular trauma (0.65%), and dermatitis of lids (0.41%). The proportion of eye diseases during navigation were conjunctivitis (43.02%), asthenopia (16.86%), xerophthalmia (15.70%), meibomianitis (11.92%), dermatitis of lids (4.94%), and ocular trauma (4.36%), while the proportion of eye diseases during the berthing period were conjunctivitis (41.39%), xerophthalmia (18.73%), asthenopia (16.62%), meibomianitis (13.90%), ocular trauma (3.32%), and dermatitis of lids (2.11%). The differences in the incidence rates between the two groups were statistically significant ( P<0.05), and the differences in the proportions between the two groups were not statistically significant ( P>0.05). Conclusion:The incidence rate of eye diseases of the crewmen on a large surface ship during navigation is much higher than that during the berthing period, and this is especially true for the incidence rates of infectious eye disease, xerophthalmia, asthenopia, and ocular trauma.
6.Analysis of ophthalmic diseases of crewmen on a certain large surface ship during its navigation and berthing
Xiaojuan LIU ; Gaiping DU ; Zheng JIN
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(4):415-418
Objective:Based on the investigation and analysis of the medical record of the ophthalmic diseases of the crewmen on a certain large surface ship during navigation and berthing, the causes of the diseases were analyzed, so as to provide a basis for the enhancement of ophthalmic medical support for large surface ships.Methods:The outpatient records of the crewmen in the Ophthalmology Department of a certain large surface ship during the navigation (84 d) and berthing (161 d) from January 2018 to August 2019 were reviewed; the incidence rate and proportion of various eye diseases were calculated; and the pathogenetic features, the whole course of diagnosis and treatment, and prognosis were statistically analyzed.Results:The eye diseases of top 6 incidence rate during navigation were conjunctivitis (8.72%), asthenopia (3.42%), xerophthalmia (3.18%), meibomianitis (2.41%), dermatitis of lids (1.00%), and ocular trauma (0.94%); the eye diseases of top 6 incidence rate in the period of berthing were conjunctivitis (8.07%), xerophthalmia (3.65%), asthenopia (3.24%), meibomianitis (2.71%), ocular trauma (0.65%), and dermatitis of lids (0.41%). The proportion of eye diseases during navigation were conjunctivitis (43.02%), asthenopia (16.86%), xerophthalmia (15.70%), meibomianitis (11.92%), dermatitis of lids (4.94%), and ocular trauma (4.36%), while the proportion of eye diseases during the berthing period were conjunctivitis (41.39%), xerophthalmia (18.73%), asthenopia (16.62%), meibomianitis (13.90%), ocular trauma (3.32%), and dermatitis of lids (2.11%). The differences in the incidence rates between the two groups were statistically significant ( P<0.05), and the differences in the proportions between the two groups were not statistically significant ( P>0.05). Conclusion:The incidence rate of eye diseases of the crewmen on a large surface ship during navigation is much higher than that during the berthing period, and this is especially true for the incidence rates of infectious eye disease, xerophthalmia, asthenopia, and ocular trauma.
7.Meta analysis of clinical outcome of intramedullary nails versus locking plates for two-part proximal humerus fracture
Lei WANG ; Fengfeng WANG ; Yanhui MA ; Jie ZHANG ; Fang HU ; Gaiping MA ; Meimei LIU ; Zhangwen MA
Chinese Journal of Tissue Engineering Research 2017;21(3):478-484
BACKGROUND:Intramedul ary nails and locking plates are widely used for two-part proximal humerus fracture. Which is better for two types of implants in patients remains controversial. OBJECTIVE:To determine the clinical outcome of intramedul ary nails versus locking plates for two-part proximal humerus fracture according to Cochrane Meta analysis. METHODS:We searched PubMed, SCI, Embase, the Cochranel Library and CBMdisc, VIP information, Wanfang Database, and CNKI for randomized control ed trials and quasi-randomized control ed trials on intramedul ary nails and locking plates for two-part proximal humerus fracture. RevMan 5.2 software was used to analyze operation time, intraoperative blood loss, fracture healing time, postoperative complications (heterotopic ossification, pain, screw penetration, necrosis of humeral head), and Constant Score. RESULTS AND CONCLUSION:Six articles of clinical control ed trials were included with 259 patients. 131 patients received intramedul ary nails, and 128 patients received locking plates. Meta-analysis displayed that no significant difference in fracture healing time, heterotopic ossification, pain, necrosis of humeral head and Constant Score was detected between intramedul ary nails and locking plates for two-part proximal humerus fracture. Operation time, intraoperative blood loss, and screw penetration were significantly less in the fixation with intramedul ary nails than that in locking plates (P<0.05). These findings suggested that compared with locking plates, intramedul ary nails method for two-part proximal humerus fractures could reduce screw penetration.
8.A Care Partner-Frailty Index-Comprehensive Geriatric Assessment questionnaire′s preliminary application research
Yufeng QIAO ; Xuejun LIU ; Yufeng DU ; Gaiping HUANG
Chinese Journal of Practical Nursing 2017;33(25):1934-1939
Objective To apply the Chinese version of Care Partner-Frailty Index-Comprehensive Geriatric Assessment (CP-FI-CGA) in Taiyuan part of elderly patients and study theirs frailty conditions. Methods To Choose the Chinese version of CP-FI-CGA questionnaire, patients′ general information questionnaire and Clinical Frailty Scale to evaluate 385 patients and analyze the results statistically. Results Of 385 patients, female patients were 166 cases (43.12%);the frailty index score was (0.318 ± 0.165) points, the CFS was 5.044 ± 1.483. Single factor analysis showed that age, marital status, the kinds of medication which the patients used, how much help the patient required, the condition of social support, and the sleep state, these six factors had statistical significance (Z=-7.292, Z=-1.994, χ2=27.726, Z=-9.688,χ2=8.117,χ2=53.477, all P<0.01). Multiple linear regression analysis showed that age, the kinds of medication which the patients used, how much help the patient required and the sleep state, these four factors were independent factors (model R=0.610, R2=0.372; adjusted R2=0.362, F=37.241, P< 0.01). Conclusions CP-FI-CGA questionnaire can accurately estimate the frailty degree by evaluating patients′each system and can be promoted in the clinical geriatric ward and nursing home, etc.
9.Investigation and analysis of refraction surgery in Navy recruits
Gaiping DU ; Zhen LI ; Mingxia SONG ; Xuechun LIU ; Yifei HUANG
Chinese journal of nautical medicine and hyperbaric medicine 2017;24(2):97-99
Objective To investigate refraction surgery in Navy recruits from 2014 to 2015,so as to provide reference for the development of visual examination standards in navy recruitment.Methods A total of 4 190 Navy recruits were enrolled for the study.Before visual examination,a questionnaire survey was made on such medical indexes as modes of refraction surgery,the time of surgery,discomfort after surgery,etc.Scores were evaluated and statistical analysis of the obtained data was made.Results The 4 190 recruits who took part in the survey were from 12 provinces and municipalities directly under the Central Government.In the 4 190recruits,650 once received refraction surgery before they entered the service,accounting for 15.5%.In the refraction surgery they received,most surgical procedures involved corneal stroma (87.6%) and corneal surface (12.4%).There were 285 cases that experienced discomfort after surgery,accounting for 43.8%.The types of discomfort were:sense of fatigue after reading (80 cases,accounting for 12.3%),decrease of night vision (43 cases,accounting for 6.6%),and glare (30 cases,accounting for 4.6%),double imaging (10 cases,accounting for 1.5%),and dry eye (122 cases,accounting for 18.8%).Conclusions Proper revision of the present visual examination standards could not only satisfy the demands on the knowledge and physics of military personnel under modern high-tech scenario,but exclude those prospective recruits with potential visual disorders and surgical complications from navy barracks.
10.Investigation and analysis of refraction surgery in Navy recruits
Gaiping DU ; Zhen LI ; Mingxia SONG ; Xuechun LIU ; Yifei HUANG
Chinese journal of nautical medicine and hyperbaric medicine 2017;24(2):97-99
Objective To investigate refraction surgery in Navy recruits from 2014 to 2015,so as to provide reference for the development of visual examination standards in navy recruitment.Methods A total of 4 190 Navy recruits were enrolled for the study.Before visual examination,a questionnaire survey was made on such medical indexes as modes of refraction surgery,the time of surgery,discomfort after surgery,etc.Scores were evaluated and statistical analysis of the obtained data was made.Results The 4 190 recruits who took part in the survey were from 12 provinces and municipalities directly under the Central Government.In the 4 190recruits,650 once received refraction surgery before they entered the service,accounting for 15.5%.In the refraction surgery they received,most surgical procedures involved corneal stroma (87.6%) and corneal surface (12.4%).There were 285 cases that experienced discomfort after surgery,accounting for 43.8%.The types of discomfort were:sense of fatigue after reading (80 cases,accounting for 12.3%),decrease of night vision (43 cases,accounting for 6.6%),and glare (30 cases,accounting for 4.6%),double imaging (10 cases,accounting for 1.5%),and dry eye (122 cases,accounting for 18.8%).Conclusions Proper revision of the present visual examination standards could not only satisfy the demands on the knowledge and physics of military personnel under modern high-tech scenario,but exclude those prospective recruits with potential visual disorders and surgical complications from navy barracks.

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