2022 Vol. 38, No. 11

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Current Situation, Existing Problems and Future Development of External Use of Traditional Chinese Medicine
MIAO Ming-san, LIU Hao-zhe, PENG Meng-fan, TIAN Shuo
2022, 38(11): 961-969. doi: 10.14148/j.issn.1672-0482.2022.0961
[Abstract](859) [FullText HTML] (198) [PDF 1804KB](78)
Abstract:
The external use of traditional Chinese medicine has attracted wide attention at home and abroad because of its remarkable curative effect, convenient use and small adverse reactions, especially in the foreign market. However, with the rapid development, there are some key problems in the external use of traditional Chinese medicine. In this case, based on the analysis of the present situation of external use preparations of traditional Chinese medicine and the modern clinical application and research of external use of traditional Chinese medicine, the author puts forward three main problems existing in external use of traditional Chinese medicine: the theory of external use of traditional Chinese medicine needs to be improved, a lack of partial normative system, clinical data analysis and summary and clinical application of new topical preparations of traditional Chinese medicine. The possible solutions are put forward, that is, to establish a theoretical system and normative system to guide the external use of traditional Chinese medicine, enrich the efficacy of existing external use traditional Chinese medicine, organize professionals to mine, summarize and analyze clinical data, cultivate professionals and strengthen the construction of external use platform of traditional Chinese medicine, so as to provide reference for the research and development of traditional Chinese medicine dosage forms and clinical safe drug use.
The Perspective of the Research on Traditional Chinese Medicine Based on Structural Chinese Medicine: Taking the External Use of TCM as An Example
QIAO Hong-zhi, CHEN Xi, CHEN Jun, DI Liu-qing
2022, 38(11): 970-975. doi: 10.14148/j.issn.1672-0482.2022.0970
[Abstract](329) [FullText HTML] (23) [PDF 1597KB](51)
Abstract:
The aggregation state of matter at different scales is the key factor to determine its properties. Structural Chinese medicine is a new cross field of Chinese medicine to study the composition and structure characteristics, formation mechanism, fate in vivo and functional correlation of clusters and aggregates naturally existing or formed by processing in traditional Chinese medicine (TCM). Compared with the traditional molecular level research of TCM, the research objects of structural Chinese medicine have the characteristics of cross-scale, heterogeneity and multi-effect. It is a re-understanding and re-study of the pharmacodynamic substances and the effective mechanism of TCM from the mesoscopic perspective and spatial dimension. External use has been the characteristic of TCM for thousands of years, but lack of in-depth explanation. Taking the external use of TCM as an example, this paper analyzes the common and individual problems existing in the research of TCM, and puts forward the research path based on the thinking of structural Chinese medicine, in order to provide reference for the related fields.
External Application of Traditional Chinese Medicine in Obstetrical and Gynecological Diseases
TAN Yong, WANG Ru-xin
2022, 38(11): 976-982. doi: 10.14148/j.issn.1672-0482.2022.0976
[Abstract](182) [FullText HTML] (199) [PDF 2240KB](40)
Abstract:
External application of traditional Chinese medicine in obstetrical and gynecological diseases has unique advantages and efficacy with a long history and wide usage. The common treatments include fumigation and washing, suppository, enema, application therapy, tongue dabbing, nasal sniffing, as well as resuscitating with aromatics. Besides, the therapeutic range covers menstruation, leucorrhea, fetation, parturition, together with some miscellaneous diseases in vulva and breast abstracts. In order to better promote and study the characteristic therapies of Chinese medicine, we reviewed the ancient and modern treatments and applications of external application of traditional Chinese medicine in obstetrical and gynecological diseases.
Advances in Molecular Pharmaceutics of Transdermal Drug Delivery Preparations of Traditional Chinese Medicine
XUE Ya-qi, WANG Zhu-xian, LIANG Pei-yi, CHEN Hong-kai, ZHAI Dan, LIU Li, JIANG Cui-ping, SHEN Chun-yan, LIU Qiang
2022, 38(11): 983-989. doi: 10.14148/j.issn.1672-0482.2022.0983
[Abstract](189) [FullText HTML] (26) [PDF 1881KB](77)
Abstract:
Molecular pharmaceutics is a discipline that studies the law and mechanism of preparations at the molecular level. It can clarify the forming principle of transdermal drug delivery and the molecular mechanism of drug release and transdermal penetration affected by the molecular interaction among drugs, matrices and organisms. In recent years, molecular pharmaceutics has been applied more and more in transdermal drug delivery. In this paper, the application of molecular pharmaceutics in transdermal drug delivery preparations of traditional Chinese medicine was reviewed, and the molecular interaction of transdermal drug delivery in preparation, drug release and skin penetration, as well as the molecular mechanism of penetration enhancer in traditional Chinese medicine promoting drug penetration into skin was investigated. It provides reference for the application of molecular pharmaceutics in the study of transdermal drug delivery preparations, so as to promote the development and wide application of transdermal drug delivery preparations of traditional Chinese medicine.
The Historical Origin and Modern Research Progress of External Treatment of Traditional Chinese Medicine
WANG Peng, SHEN Jie, SHI Sheng-jie, WANG Yuan-biao
2022, 38(11): 990-999. doi: 10.14148/j.issn.1672-0482.2022.0990
[Abstract](506) [FullText HTML] (492) [PDF 1819KB](71)
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On the basis of reviewing the historical source of external treatment of traditional Chinese medicine, the development status of modern external treatment method is sorted out from theoretical, technical and clinical aspects, which is mainly reflected in the proposal of new theories, the improvement of dosage forms and application methods of external Chinese medicine, the innovation of external treatment equipment and the broadening of the scope of application of clinical "external treatment of internal diseases", and puts forward thoughts on the current problems in this field of research, and looks forward to future research trends.
Exploration on the Characteristics of Chinese Medicine External Treatment Method to Prevent and Treat Epidemic Diseases
WU Cheng-yan, SHI Qing-wu, WU Cheng-yu
2022, 38(11): 1000-1008. doi: 10.14148/j.issn.1672-0482.2022.1000
[Abstract](312) [FullText HTML] (92) [PDF 1788KB](36)
Abstract:
Chinese medicine has accumulated rich experience in the prevention and treatment of epidemic diseases over the ages, and has formed a complete system for it, among which the external treatment method is a distinctive aspect. This study incorporates a total of 75 formulae on external treatment for the prevention and treatment of epidemic diseases, which have the following characteristics: ①Naming mostly featured by "bi wen (preventing plague)" and "sha gui (killing ghosts)" to highlight the role in preventing epidemic diseases; ②Formulation featured by lozenge, moxa stick, joss stick, medicinal cake, and other 11 types in addition to the common pill, powder and decoction; ③Application method featured by fumigation, wearing, coating, powdering, nose blowing, sneezing, bathing, eye dropping, and other external methods; ④Medication featured by mainly pungent and warm medicines with a medication frequency above 5 out of 24 medicines, metal and stone medicines, aromatic medicines, and other 176 medicines. In addition, there are also some rare medicines, which are worthy of further study and utilization.
Explore the Application Prospect of External Chinese Medicine in the Prevention of Influenza from Nasal Mucosal Immunity
DONG Yi-zhi, ZHANG Yue, LI Hao-yue, HAO Ming-zhao, LI Xiao-lei, ZHAO Jing
2022, 38(11): 1009-1014. doi: 10.14148/j.issn.1672-0482.2022.1009
[Abstract](148) [FullText HTML] (23) [PDF 2161KB](26)
Abstract:
Influenza is an acute respiratory infectious disease caused by influenza virus, which has caused many world influenza pandemics and seriously harmed human health. The nasal cavity is directly connected with the outside world, and is the main entrance of influenza virus into the host. The nasal mucosa and the corresponding immune system on its surface are the first line of defense against pathogen invasion, and play a role in local immunity and stimulate overall immunity in influenza prevention. This paper mainly discusses the advantages of regulating nasal mucosal immunity by external application of Chinese medicine to prevent influenza from the role of nasal mucosal immunity in influenza prevention and the related research of external traditional Chinese medicine based on mucosal immunity in influenza prevention, in order to provide more ideas for external application of Chinese medicine to prevent influenza.
Exploration of the Prescription Rule of Kaichi Prescription and Anti-Inflammation Mechanism of the Core Prescription in Compilations of Chinese Medical Formulae Recorded by Imperial Court: Oral Medicine Based on the Excavation of Ancient Literature and Network Pharmacology
WU Feng-zhen, LIU Jing, ZHU Min-min, WANG Zhen-guo
2022, 38(11): 1015-1026. doi: 10.14148/j.issn.1672-0482.2022.1015
[Abstract](134) [FullText HTML] (21) [PDF 5490KB](31)
Abstract:
  OBJECTIVE  To excavate the medication rule of Kaichi prescription in Compilations of Chinese Medical Formulae Recorded by Imperial Court: Oral Medicine and analyze the anti-inflammation mechanism of core prescription.  METHODS  Collect and organize the Kaichi prescription in Compilations of Chinese Medical Formulae Recorded by Imperial Court: Oral Medicine and perform descriptive statistical analysis, analysis of high-frequency Herb pairs and Herb groups, and analysis of core prescription and anti-inflammation mechanism of core prescription.  RESULTS  A total of 102 Kaichi prescriptions were collected, mainly for the treatment of gingival diseases, with 33 kinds of high-frequency Herbs with a frequency of more than 5, such as Radix et Rhizoma Asari, Rhizoma Cimicifugae, Fructus Gleditsiae, Halitum, Moschus, etc. Forty-six drug pairs and drug groups were obtained by association rule analysis, and the core prescription with herbs composition of Rhizoma Cimicifugae, Radix Angelicae Dahuricae, Radix et Rhizoma Asari and Rhizoma Ligustici was found. The active ingredients of the core prescription, including kaempferol and byakangelicol, can affect lipid and atherosclerosis, pathways in cancer and kaposi sarcoma-associated herpesvirus infection acting on targets such as PTGS2, PIK3CA and MAPK8 to treat inflammation.  CONCLUSION  The Kaichi prescription makes good use of wind medicine, focusing on dispelling wind and relieving pain, aromatic deodorization, as well as clearing heat and reducing internal heat. The core prescription has the characteristics of multi-components, multi-targets and multi-pathways in the treatment of inflammation.
Study on the Regulatory Effect of Realgar for External Use on Epithelial Mesenchymal Transformation in Triple Negative Breast Cancer
WANG Chun-hui, CHU Ai-jing, ZHU Zhen-yu, PEI Xiao-hua
2022, 38(11): 1027-1034. doi: 10.14148/j.issn.1672-0482.2022.1027
[Abstract](174) [FullText HTML] (29) [PDF 5250KB](34)
Abstract:
  OBJECTIVE  To investigate the regulatory effect of realgar for external use on epithelial mesenchymal transformation in triple negative breast cancer.  METHODS  Human breast cancer nude mouse xenograft model was established by injecting MDA-MB-231 cells. The mice were randomly divided into model group, realgar group and capecitabine tablet group. Hematoxylin and eosin (HE), immunohistochemistry, Western blot and qPCR were used to observe the effect of realgar on epithelial-mesenchymal transition (EMT) of breast cancer. At the same time, the indexes of blood routine, liver and kidney function were detected.  RESULTS  External using realgar could induce necrosis of breast cancer tissue, the tumor inhibitory rate was 30.2%. Compared with the model group, the liver and kidney functions and blood routine tests of nude mice in realgar group were not significantly abnormal; The immunohistochemical results of tumor tissues suggested that realgar could enhance the expression of E-cadherin and reduce the expression of Vimentin; The results of Western blot and qPCR showed that realgar could enhance the expression of E-cadherin and reduce the expressions of Twist1 and TGF-β1 in tumor tissues (P < 0.05).  CONCLUSION  External using realgar can inhibit the growth of triple negative breast cancer and regulate EMT by increasing the expression of E-cadherin and decreasing the expressions of Vimentin, Twist1 and TGF-β1.
Study on Enhanced Permeation Mechanism of Sanfu Patch at Acupoints Based on Skin TRP Channels
LAI Rong-rong, ZHAI Yuan-hao, LIN Yuan-yuan, ZENG Yao, WU Yan, XU Yue-hong
2022, 38(11): 1035-1042. doi: 10.14148/j.issn.1672-0482.2022.1035
[Abstract](186) [FullText HTML] (25) [PDF 3691KB](26)
Abstract:
  OBJECTIVE  To clarify the mechanism of per-acupoint penetration of Sanfu patch, study the effects of the active ingredients of Sanfu patch including sinapine thiocyanate (SPT) and tetrahydropalmatine (THP) on TRP channels, and further evaluate the influence of activating TRP channels on the transdermal behavior of Sanfu patch.  METHODS  The activation of TRP channels in dorsal root neurons (DRG) by the active ingredients of Sanfu patch was investigated by calcium-imaging experiments. The expressions of TRPV1 and TRPA1 in the skin of Feishu (FS) acupoints and non-Feishu (NFS) acupoints were detected by Western blot and immunofluorescence, and the changes of TRPA1 expression after administration with Sanfu patch were also measured by immunofluorescence. The effect of activating TRP channels by Sanfu patch on acupoint transdermal behavior was studied using in vivo transdermal and confocal laser 3D scanning.  RESULTS  The active ingredient SPT in Sanfu patch could promote the influx of Ca2+ mediated by TRP channels. The expression levels of TRPV1 and TRPA1 channels in the skin of FS acupoints were significantly higher than those of NFS acupoints skin (P < 0.05), and TRPA1 channels decreased after sustained treatment with Sanfu patch. After the activation of TRPV1 and TRPA1 channels in the skin, the retention of SPT and THP in the skin of FS acupoints significantly increased (P < 0.05), but there was no significant effect on NFS acupoints skin.  CONCLUSION  The active ingredient SPT in Sanfu patch has an agonistic effect on TRP channels, and the expression of TRPV1 and TRPA1 channels in FS acupoint skin is higher than those in NFS acupoint. The higher expressions of TRPV1 and TRPA1 channels and their activation by Sanfu patch are one of the mechanisms of its penetration-promoting through acupoint administration.
Research Progress of New Technologies and Methods for Promoting Penetration of Transdermal Drug Delivery Systems
HE Jin-ying, ZHANG Yong-ping
2022, 38(11): 1043-1049. doi: 10.14148/j.issn.1672-0482.2022.1043
[Abstract](295) [FullText HTML] (163) [PDF 3445KB](60)
Abstract:
In recent years, transdermal administration has been more and more popular because of its simplicity, convenience, efficacy and low cost because it can overcome the shortcomings of gastrointestinal digestive reaction after oral administration, liver first-pass effect, and pain caused by injection administration. more and more people's attention. However, solving the low absorption efficiency of transdermal administration has become a key problem in the research of modern pharmaceutical preparations. By consulting relevant literature, it is found that nanocarriers, new methods of promoting penetration of volatile oils of traditional Chinese medicine, and new technologies of physical penetration provide new ideas for improving the absorption efficiency of transdermal drug delivery; therefore, this paper focuses on summarizing and analyzing the existing In order to provide reference and reference for the new technology and new method of percutaneous permeation promotion for external use.
Pharmacokinetic Study of Skin and Blood of Sinomenine-Loaded Microemulsion Gel Based on Double Sites Simultaneous Microdialysis
DING Yang, QIAN Shan-shan, GUO Jian, GUI Shuang-ying
2022, 38(11): 1050-1055. doi: 10.14148/j.issn.1672-0482.2022.1050
[Abstract](150) [FullText HTML] (12) [PDF 2433KB](25)
Abstract:
  OBJECTIVE  To investigate the pharmacokinetics of sinomenine-loaded microemulsion gel (SMG) by skin and blood microdialysis in rats, and explore the pharmacokinetic characteristics of SMG.  METHODS  An UPLC method for the determination of sinomenine was established, and its specificity, linearity, precision and recovery rate were examined. The probe was implanted after the rats were anesthetized and depilated, then the sinomenine microemulsion gel was applied onto the bare abdominal skin of the rats. The microdialysis technique and UPLC were used to determine the concentration of the drug.  RESULTS  The results showed that the established method for the determination of sinomenine microemulsion gel was well linear in the range of 0.5-20 μg·mL-1, and the specificity, degree of precision and recovery rate of the chromatography all conformed to the examination requirements of microdialysis samples.The results of pharmacokinetic study showed that the Cmax values of sinomenine in skin and blood were (10.91±3.05) and (6.74±1.91)μg·mL-1, respectively. The Tmax values were (180.00±39.80) and (239.98±40.85)min, respectively. And the AUC0→t values were (736.51±45.30) and (426.43±30.18)μg·min·mL-1.  CONCLUSION  The sinomenine microemulsion gel plays a role in forming skin reservoir through percutaneous penetration, and can control the sustained release of drug.
Study on the Preparation and Transdermal Permeability of Soluble Microneedles Loaded with Gastrodin in vitro
WANG Shu-hui, YANG Ming, ZHU Wei-feng, CHEN Li-hua, LI Zhe, WU Wen-ting, GUAN Yong-mei
2022, 38(11): 1056-1061. doi: 10.14148/j.issn.1672-0482.2022.1056
[Abstract](124) [FullText HTML] (20) [PDF 2783KB](20)
Abstract:
  OBJECTIVE  To prepare soluble microneedles loaded with gastrodin, and to investigate their physical and chemical properties and transdermal properties in vitro.  METHODS  The soluble microneedles loaded with gastrodin were prepared by two-step centrifugation method, and the drug loading was determined by HPLC. Morphology, mechanical properties, skin puncture performance and recovery performance were investigated. The in vitro transdermal properties were investigated by Franz diffusion cell.  RESULTS  The prepared microneedles had complete array, good flexibility and good mechanical properties. The drug loading of each tablet was up to (5.45±0.14)mg, and the skin could be successfully penetrated. The skin could be restored to its original state within 2 h after the treatment. In vitro skin infiltration results showed that the cumulative osmotic amount of gastrodin in the fully loaded microneedles reached 87% after 12 h, while the cumulative osmotic amount of gastrodin in the gastrodin solution was 12%, indicating that the soluble micro-target gastrodin had a good promoting effect on transdermal delivery of gastrodin.  CONCLUSION  The soluble microneedles prepared in this study have good mechanical strength and flexibility, and can realize transdermal delivery of water-soluble drugs.
Pharmacokinetic and Pharmacodynamic Evaluation of Crebanine Patch in Rats
CUI Li-li, LI Jing-yu, XU He, YANG Zi-xian, MA Yun-shu
2022, 38(11): 1062-1068. doi: 10.14148/j.issn.1672-0482.2022.1062
[Abstract](167) [FullText HTML] (20) [PDF 2355KB](14)
Abstract:
  OBJECTIVE  To compare the pharmacokinetic differences between the percutaneous and intragastric administration of Crebanine in rats. To evaluate the effect of Crebanine patch on anti-arrhythmia in rats and the mechanism of Crebanine on calcium channel.  METHODS  The plasma concentration of Crebanine in rats was determined by HPLC. The anti-arrhythmic effect of Crebanine transdermal administration was observed in the model of barium chloride induced arrhythmia in rats, and Whole Cell recording was used to detect the effect of Crebanine on calcium channel current.  RESULTS  The main pharmacokinetic parameters of Crebanine patch for transdermal administration (400 mg·kg-1) were as follows: AUC0-∞=(204.500±170.496)mg·h·L-1; Tmax=(10.333±0.745)h; Cmax=(1.968±0.147)mg·L-1 (n=6). The main pharmacokinetic parameters of Crebanine solution for intragastric administration (40 mg·kg-1) were as follows: AUC0-∞=(26.980±6.672)mg·h·L-1; Tmax=(0.086±0.024)h; Cmax=(8.991±2.343)mg·L-1 (n=6). Compared with the negative group, the time required for recovery of sinus rhythm was significantly shortened (P < 0.01), and the number of rats recovering sinus rhythm significantly increased (P < 0.01) after transdermal administration of the patches in 79, 158, 316 mg·kg-1 groups. The number of rats that could recover sinus rhythm within 20 min after administration increased significantly (P < 0.001). The number of rats that maintained sinus rhythm for more than 20 min after the restoration increased significantly (P < 0.01). Both T-type and L-type calcium channels were inhibited by Crebanine.  CONCLUSION  The administration of Crebanine patch has slow elimination and sustained release effect, can significantly inhibit barium chloride induced arrhythmia in rats by inhibiting calcium channels, and significantly prolong the action time, so as to achieve the purpose of reducing toxicity and increasing efficiency.
Study on the Percutaneous Absorption Behavior of Compound Nanxing Zhitong Plaster Based on Different Skin Model
QIAO Peng-li, WEI Xu-chao, QU Ye-qing, DONG Jie, YIN Shu-mei, ZHENG Shi-zhong, CHEN Jun
2022, 38(11): 1069-1074. doi: 10.14148/j.issn.1672-0482.2022.1069
[Abstract](193) [FullText HTML] (64) [PDF 2257KB](25)
Abstract:
  OBJECTIVE  To evaluate the biopharmaceutical properties of five active ingredients in Compound Nanxing Zhitong Plaster (CNZP)by composite phospholipid liposome-based artificial skin membrane (CPLASM).  METHODS  The HPLC analysis method was established to simultaneously determine five active ingredients (cinnamic aldehyde, paeonol, eugenol, methyl salicylate and imperatorin) in CNZP. CPLASM were prepared and used to measure the in vitro transdermal absorption parameters of the five active ingredients from CNZP in comparison with Strat-MTM, the marketed artificial skin membrane. The obtained parameters were further compared with those obtained by rat skin and porcine ear skin.  RESULTS  The five active components can be simultaneously measured by HPLC analysis. Among the five active ingredients, eugenol and methyl salicylate were found to possess the best permeability. The apparent permeability coefficient correlation between CPLASM and porcine ear skin was determined to be 0.965 8 and 0.943 3 while that between Strat-MTM and porcine ear skin was found to be 0.949 3 and 0.946 0, respectively.  CONCLUSION  CPLASM can be used to evaluate the permeation behavior of plasters of Chinese medicine such as CNZP.

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