External Application Characteristics of Roots and Rhizomes of Chinese Herbal Medicines in Chinese Materia Medica / 中国实验方剂学杂志

ObjectiveTo collect and analyze the properties and application characteristics of external use of roots and rhizomes of Chinese herbal medicines in the Chinese Materia Medica（《中华本草》） to provide data references for the research on clinical external use of Chinese medicine， in order to provide data reference for clinical external use of traditional Chinese medicine（TCM）. MethodThe Chinese herbal medicines included in the Chinese Materia Medica were systematically screened. The inclusion criterion was the explicit mention of terms like "root", "rhizome", "root bark", "tuber", "tuberous root", etc. under the "Source" in the Chinese Materia Medica. Information on properties, flavors, meridian tropism, medicinal parts, fresh use, toxicity, efficacies and indications, and dosage of roots and rhizomes of Chinese herbal medicines was collected. The information was then entered into an Excel spreadsheet for statistical analysis. ResultThe Chinese Materia Medica records 2 662 roots and rhizomes of Chinese herbal medicines, of which 1 653 are suitable for external use. The predominant properties and flavors are cool, cold, bitter, pungent, and sweet. These Chinese herbal medicines mainly act on the liver, lung, and spleen meridians. The primary medicinal parts used include root, rhizome, and root bark. More than half of the roots and rhizomes of Chinese herbal medicines can be used in their fresh form. The main efficacies include clearing heat, removing toxins, resolving stasis, dispersing accumulation, resolving blood stasis and stopping bleeding, reducing swelling and alleviating pain, dispelling dampness and relieving pain. The main indications are skin sores, traumatic injuries, and rheumatic diseases. Common external application methods include poultice, decoction for washing, and applying powdered form. Most of these Chinese herbal medicines lack specific dosage guidelines for external use, with an emphasis on using an appropriate amount. ConclusionThe Chinese Materia Medica contains a wide range of roots and rhizomes of Chinese herbal medicines suitable for external use, with definite therapeutic effects, providing a broad perspective for the application of Chinese medicine externally. However, there are still problems such as unclear dosages and limited research. Further studies are necessary to better utilize the advantages of the external use of Chinese medicine.

Application Characteristics of Prescription Preparations for External Use in Chinese pharmacopoeia 2020 Edition / 中国实验方剂学杂志

ObjectiveTo analyze the clinical application characteristics of prescription preparations for external use in the Chinese pharmacopoeia 2020 edition （hereafter abbreviated as the Pharmacopoeia）. MethodThe topical functions， usage， dosage， dosage form， application method， and prescription of the preparations for external use in the Pharmacopoeia were analyzed. ResultThe Chinese pharmacopoeia 2020 edition includes a total of 138 prescription preparations for external use， the specific clinical usage， dosage， administration method， and efficacy evaluation of which remain unclear. These preparations can be used to treat a wide range of diseases. Specifically， the use in orthopedics and traumatology （36 preparations， accounting for 26.09%） is dominant， followed by that in internal medicine， surgery， and throat. The major application method is directly applying to the diseased area （35 preparations， 25.36%）. The main dosage forms are ointment （40 preparations， 28.99%） and powder （24 preparations， 17.39%） and others include liniments， suppositories， tinctures， and sprays. The clinical usage and dosage of these preparations are mostly unclear. Only 48 preparations （34.78%） are recorded with clear dosage and frequency of use， and 45 preparations （32.61%） have neither clear dosage nor frequency of use. The 138 prescription preparations for external use include 211 single medicines， of which 44 single medicines can be used alone. The single medicines are mostly used for heat clearing （48 preparations， 22.75%）. ConclusionThe Chinese pharmacopoeia 2020 edition （Volume I） records a large number of prescription preparations for external use， and the number shows an increasing trend. However， the usage， dosage， and efficacy evaluation criteria of these preparations remain to be improved and need in-depth research.

Analysis on External Function and Application of Medicinal Materials and Decoction Pieces in 2020 Edition of Chinese Pharmacopoeia (Volume 1) / 中国实验方剂学杂志

Objective:To analyze the research status of the external use of medicinal materials and decoction pieces in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> （volume 1）， so as to provide reference for the clinical external use research of Chinese medicines. Method:The external function， usage， dosage and other information of medicinal materials and decoction pieces in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> （volume 1） were analyzed and compared. Result:In the 2020 edition of <italic>Chinese Pharmacopoeia</italic> （volume 1）， there were 165 kinds of Chinese medicines that could be used externally， including 25 kinds of Chinese medicines that clearly recorded their functions for external use， such as Euphorbiae Semen， Euphorbiae Semen Pulveratum， Arisaematis Rhizoma， Arisaematis Rhizoma Preparatum， Crotonis Fructus， Crotonis Semen Pulveratum， Nardostachyos Radix et Rhizoma， Artemisiae Argyi Folium， Alumen， Stemonae Radix， Genkwa Flos， Cera Flava， Mel， Psoraleae Fructus， Gardeniae Fructus， Calomelas， Bruceae Fructus， Drynariae Rhizoma， Euphorbiae Ebracteolatae Radix， Cuscutae Semen， Phytolaccae Radix， Meretricis Concha， Talcum， Talci Pulvis and Propolis. The amount of Chinese medicine for external use recorded in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> was mostly appropriate for external use， the amount for external use was not clear. The application method for external use focused on beating powder and applying the affected areas， decocting for fumigation and washing， simmering to paste， etc. Clinical external use was used for the treatment of eczema， tinea pedis， chapped skin and other skin diseases. Conclusion:The number of Chinese medicines recorded in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> for external use is increasing， but the function， dosage and usage of these Chinese medicines for external use still need to be improved.

Technical Specification (Draft) for Clinical External Application of Traditional Chinese Medicine Tinctures / 中国实验方剂学杂志

Based on the data mining for external application technology of traditional Chinese medicine (TCM) tinctures, combined with the clinical practical application research, the clinical technical specification (draft) for TCM tinctures was formed by the experts from the external treatment branch have demonstrated for many times, including clinical applicable scope, operation procedures, methods of application, dose, frequency, time, precautions, adverse reactions and the nursing key points. It is expected to standardize the clinical application of TCM tinctures, improve the efficacy of this preparation, and reduce its adverse reactions.

Protective Effect of Yinhuangshen Essential Oil on Skin Damage in Mice with Solar Dermatitis / 中国实验方剂学杂志

Objective: To study the effect of Yinhuangshen essential oil in mice of solar dermatitis model by ultraviolet (UVB). Method: Sixty SPF BALB/c female mice were randomly divided into blank group, model group, Minlixiao group, and large and small-dose Yinhuangshen essential oil groups. Except for blank group, model group was given 0.25 mL·cm-2 normal saline on the back every day. The Minlixiao group was given Min Lixiao every day. Low-dose Yinhuangshen essential oil group was given 0.125 mL·cm-2, and large-dose group was given 0.25 mL·cm-2, once a day, and the corresponding drugs were given continuously for 8 days. Except for blank group, all of the other groups were irradiated for 1.5 hours at 15 cm away from 308 nm UVB lamp on the 6th day. One hour and 24 hours after irradiation, mice were given corresponding drug once, and skin was observed 48 hours later. Contents of nitric oxide (NO), nitric oxide synthase (NOS) and tumor necrosis factor-alpha (TNF-α) in some local skin homogenates were measured. The histopathological changes were observed by htoxylin eosin(HE) staining. Result: Compared with blank group, skin of model group was reddish, swollen and ulcerated, epithelium and adnexal were absent, a large number of inflammatory cells and necrosis were adhered to the surface, the local histopathological changes significantly (Pα were significantly increased (Pα in the skin tissue of Minlixiao group and Yinhuangshen essential oil group were significantly decreased, and it could remarkable reduce the pathological changes in local tissue morphology (PConclusion: Yinhuangshen essential oil has a good effect in preventing and treating solar dermatitis.

Mechanism of External Use of Traditional Chinese Medicine-“Three Micro-Regulations for Balance” Based on Neural-endocrine-immune Network / 中国实验方剂学杂志

The external treatment of traditional Chinese medicine(TCM) is the earliest known treatment method for diseases. It originated in pre-Qin dynasty, grew up in Han and Tang dynasties, innovated in Song and Yuan dynasties, and developed in Ming and Qing dynasties. It has made outstanding contributions to the human health.With the rapid rise of modern drug-derived diseases, the external treatment of drugs has attracted wide attention at home and abroad due to its small adverse reactions, convenient application and accurate curative effect. With the increasing of TCM for external use drugs, dosage form, method, the clinical application of TCM has been expanding unceasingly, it has been widely applied to the pediatric, gynecological, internal medicine, oncology, however, there has not many specifications for amount, usage, time, and course of treatment, which are more arbitrary. Topical use of TCM can play a direct role in the treatment of local lesions. The external use of TCM is mainly explained by "the principle of external treatment is the principle of internal treatment", and the internal use function can only be explained from the theoretical part of TCM on its external treatment characteristics, and most can not well guide the corresponding clinical application of TCM. There are few reports on the mechanism of external use of TCM, and most of them are from theory to theory, lacking the confirmation and support of modern studies. There are also related reports on transdermal absorption of scattered TCM for external use. However, most of the external use of TCM are crude preparations such as pulverising, decocting in water and alcohol extraction, and its more random which the dose, dosage type, course of treatment, external use methods, coupled with its complex ingredients and low content, it is difficult to explain the mechanism of external use simply from transdermal absorption, nor does it meet the facts of clinical application of TCM. The mechanism of external use is not clear, and restricted the development of TCM for external use. This article through the extensive experimental research, literature research and database research, and proposed that TCM for external use through adjustment of neural-endocrine-immune network disorders, through local micro effect, micro stimulation, micro absorption, that's the "three fine tuning balances", and exert external use curative effect, so as to achieve the purpose of treating diseases.

Mechanism of External Treatment with Traditional Chinese Medicine Based on“Neurological-Endocrine-Immune Network” / 中国实验方剂学杂志

With a clear efficacy in external treatment of diseases, traditional Chinese medicine(TCM) has been widely applied in surgery, in acute, pediatric, gynecological, internal medicine and other departments. Its advantages include easy use, direct access to lesions, and prevent of the first-pass effect of the liver. However, its mechanism of action is still unclear, which impacts its clinical promotion. This article makes analysis and summary on the clinical application of TCM in external treatment of diseases, the characteristics of commonly used TCM in treatment of diseases, and the relationship of the common externally treated diseases and the "neurological-endocrine-immune network". The findings showed that TCM for external treatment were widely used, with exact curative effects; the pathogenesis of commonly used TCM for externally treating diseases is closely related to the "neuro-endocrine-immune network". Moreover, the modern pharmacological effects of TCM for externally treating diseases were found to be 100%related to the "neuro-endocrine-immune network". According to the analysis of the relationship between the common diseases externally treated with TCM and the "neuro-endocrine-immune network", the pathogenesis of the treatment with TCM is closely related to the "neuro-endocrine-immune network". Therefore, we believe that the "neuro-endocrine-immune network" system is probably one of the main mechanisms of action of TCMs for externally treating diseases. The verification of this mechanism requires the joint efforts of various departments in conducting clinical or experimental verification in the future, so as to provide a reference for clarifying the mechanism of TCM for external use, and basis for the promotion and application of TCM for external use.

Thinking on safety of "toxic" traditional Chinese medicine for external use / 中国中药杂志

In recent years,the safety of " toxic" traditional Chinese medicine has received great attention. Similarly,the safety of " toxic" Chinese medicines for external use should not be ignored. In this paper,the adverse reactions of toxic Chinese medicine for external use were systematically studied; the causes for adverse reactions were analyzed; and the key problems on the external use of toxic Chinese medicine in modern clinical practice were put forward. For example,usage dosage(time,area),specific efficacy of external use,early warning index of toxicity,toxic dose,adverse effects,toxic symptoms and corresponding treatment measures all had no reference basis,lacking a systematic toxicity evaluation medication criteria for clinical external use of toxic Chinese medicine. Attention shall be paid to the toxicity of toxic Chinese medicine for external use,and the theory of toxicity evaluation should be established for the external use of " toxic" traditional Chinese medicine under specific conditions. The early warning mechanism for toxic and adverse effects were clarified,and relevant early warning sensitive indicators applicable to clinical use were established in this study to control its risk factors. The study on the mechanism of pharmacodynamics and toxicology of " toxic" traditional Chinese medicine for external use was strengthened to clarify the usage and specific effects of external use. On the basis of this,the study of synergism and reduction of toxicity was carried out to maximize the efficacy of external use of traditional Chinese medicine under specific conditions. A toxicity standard of " toxic" Chinese medicines for external use was put forward,which was of great significance to guide clinical safety,rationality,effectiveness as well as the research and development of new dosage forms for external use of traditional Chinese medicine.

Clinical Observation of Kangfuxin Solution Combined with rhEGF Solution for External Use in the Treat-ment of Vitamin B12 Deficiency Atrophic Glossitis / 中国药房

OBJECTIVE:To observe the clinical efficacy and safety of Kangfuxin solution combined with rhEGF solution for external use in the treatment of vitamin B12 deficiency atrophic glossitis. METHODS:Totally 94 patients with vitamin B12 deficien-cy atrophic glossitis in Xinjiang Production and Construction Corps Hospital during Jul. 2012-Jun. 2015 were divided into observa-tion group and control group according to random number table,with 47 cases in each group. Both groups received etiological treat-ment of vitamin B12 supplement. Control group was additionally given rhEGF solution for external use on tongue surface,qid. Based on control group,observation group was additionally given Kangfuxin solution and applied medical gauze saturated with liq-uid medicine to the affected area,more than 30 min each time,tid. Treatment course of 2 groups lasted for 4 week,a referral of the week. Clinical efficacies were compared between 2 groups as well as average pain indexes and lesion areas of tongue before and after treatment,and the occurrence of ADR. RESULTS:Cure rate(76.6% vs. 57.4%)and total response rate(97.9% vs. 83.0%) of observation group were significantly higher than those of control group,with statistical significance (P0.05). 1-4 weeks after treatment,average pain indexes and lesion areas of tongue in 2 groups were significantly decreased,with statistical sig-nificance compared to before treatment (P<0.05). The average pain indexes of observation group were significantly lower than those of control group (3,4 weeks after treatment),and lesion areas of tongue was significantly smaller than control group (2-4 weeks after treatment),with statistical significance(P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:For vita-min B12 deficiency atrophic glossitis,Kangfuxin solution combined with rhEGF solution for external use can significantly improve tongue lesion and have good analgesic effect and safety.

Analysis of Labeled Items in Package Inserts of 51 Kinds of Ointment for External Use / 中国药房

OBJECTIVE:To provide reference for reasonably designing package inserts of ointment for manufacturers. METH-ODS:According to items included in Management Regulation for Package Insert and Label and Specification for Chemicals and Bi-ological Products for Treatment,labeled items in package inserts of 51 kinds of ointment for external use during Jan.-Jun. 2016 in our hospital were analyzed. RESULTS:Among the 51 kinds of ointment,39 were domestic varieties and 12 were imported variet-ies. In the package inserts of 39 domestic varieties,items with lower labeling rates were overdose,pharmacokinetics,use guid-ance,pharmacology and toxicology,with labeling rates of 2.6%,5.1%,15.4%,28.2%;while the labeling rates of imported vari-eties were 16.7%,83.3%,75.0%,100%. Compared with package inserts of imported ointment,composition,dosage and usage, adverse reactions,contraindications,precautions,drug interactions,medication for special populations were not enough detailed in domestic ointments. CONCLUSIONS:It is suggested that manufacturers consult medicine experts, list all auxiliary materials through Management Regulation for Drug Description and Label,refine and improve the labeling contents of dosage and usage,ad-verse reactions,precautions,medication for special populations,pharmacology and toxicology,overdose,etc. In addition,admin-istrative departments should strengthen the regulatory approval efforts.

Clinical analysis of treatment for obesity hypertension with western medicine and Chinese medicine Tong Shui San / 中国基层医药

Objective To analyze clinical effect of treatment for obesity hypertension with western medicine and Zhong Yao Wai Yong Tong Shui San,to provide a reference for clinical drugs.Methods 150 obesity hyperten-sion patients were selected,they were divided into group A,B,C according to mathematical random method,50 cases in each group.Ammonia amlodipine was used in group A,dimethyl biguanide was used in group B,besides ammonia amlodipine and dimethyl biguanide,self-made Zhong Yao Wai Yong Tong Shui San were used in group C.Index such as insulin and blood pressure were compared in three groups.Results Rate of blood pressure control of group C was 96.00%,higher than that of group A (80.00%)and group B (82.00%),there were statistical difference (χ2 =6.495,P=0.008;χ2 =6.215,P=0.010);after the treatment,DBP and SBP of group C were (73.75 ±6.83)mmHg and (122.66 ±11.46)mmHg,better than group A and group B(all Pgroup B >group A,there were statistical difference (all P <0.05 ).Conclusion Combination of western medicine and Zhong Yao Wai Yong Tong Shui San has a good performance in improving blood pressure,blood lipids and insulin.

Clinical Observation of Mirabilite Combined with Cisplatin Intraperitoneal in the Treatment of Elderly Colorectal Malignant Ascites / 中国药房

OBJECTIVE:To observe the clinical efficacy and ADR of Mirabilite combined with intrapetitoneal in the treatment of elderly colorectal malignant ascites. METHODS:77 cases of patients with elderly colorectal malignant ascites were randomly di-vided into treatment group (n=40) and control group (n=37). The control group received the treatment of intraperitoneal alone, while the treatment group was based on the control group additionally received Mirabilite combined with intrapetitoneal. The clini-cal efficacy,quality of life (QOL),and ADR in 2 groups were compared and statistically analyzed. RESULTS:Compared with control group,the effective rate in treatment group was 77.5% and the disease control rate was 87.5%,with significant difference (P<0.05);the QOL score in treatment group was better than control group,with significant difference(P<0.05);the incidence of local ADR in Mirabilite for external use was low. CONCLUSIONS:Mirabilite combined with intraperitoneal has better efficacy in the elderly colorectal malignant ascites and better QOL.

Analysis on Present Situation of ADR of Traditional Chinese Medicine for External Use / 中国中医药信息杂志

This article reviewed occurrence of ADR of clinical external use of 50 Chinese medicinal herbs, such as Verbascum Thapsus, Ranunculus Sceleratus, and Euphorbia Esula. It summarized from foundation, property, efficacy, clinical manifestation, and classification of ADR, and discussed early warning ways of ADR from TCM external use, with a purpose to provide references for TCM reasonable medication.

Clinical Efficacy of Recombinant Human Interferon α-2b Gels Combined with Ulcer Powders for External Use in the Treatment of Cervicitis with Human Papillomavirus Infection / 中国药师

Objective:To investigate the clinical efficacy of recombinant human interferon α-2b gels combined with ulcer powders for external use in the treatment of cervicitis patients with human papillomavirus infection. Methods: Totally 76 cases of cervicitis patients with human papillomavirus infection were randomly divided into the observation group and the control group. The observation group was treated by recombinant human interferonα-2b gels combined with ulcer powders for external use through vaginal administration, once every 2d on bedtime. The control group was treated only by ulcer powders for external use. After the 6-month treatment, the HPV negative conversion rate, clinical efficacy and adverse drug reactions in the two groups were detected. Results:After the treatment, the HPV negative conversion rate of the observation group was 83. 33%, which was higher than that of the control group (60. 00%, P <0. 001). The total effective rate of the observation group was 88. 89%, which was higher than that of the control group (82. 50%, P < 0. 05). Conclusion: The clinical efficacy of recombinant human interferon α-2b gels combined with ulcer powders for external use in the treatment of cervicitis patients with human papillomavirus infection is significant, which is worthy of wider application.

Clinical Observation of External Use of Wusheng Tincture for Treatment of Cancer Pain / 广州中医药大学学报

Objective To investigate the therapeutic efficacy of Chinese medicine of Wusheng Tincture for external application in treating cancer pain, and to observe its effect on the quality of life ( QOL) of cancer patients. Methods Eighty-three cancer pain patients were randomized into treatment group (N=42) and control group (N=41). Except 5 cases dropping out for the itch of skin, a total of 78 cases finished the treatment, 40 in the treatment and 38 in the control group. The patients were given the corresponding medicine according to the classification of numerical rating scale ( NRS) scores. In the control group, the patients were treated following the three-step analgestic ladder issued by World Health Organization ( WHO). The treatment group was given external application of Wusheng Tincture on the painful regions based on the same three-step analgestie ladder treatment as that of the control group, the treatment course lasting 7 days. The rating scale NRS scores and QOL scores were observed for the assessment of therapeutic effect and QOL of the two groups. Results (1) On medication day 7, NRS scores in both groups were decreased as compared with those one day before treatment (P0.05) . (2) The total effective rate of the treatment group was 82.5%, and that of the control group was 68.4%, the difference being significant between the two groups ( P0.05) . ( 3) On medication day 7, QOL scores were much lower in both groups than those one day before medication, the difference being significant ( P0.05) . Conclusion External application of Wusheng Tincture may have certain therapeutic effect in treating patients with mild cancer pain, but fails in enhancing the effect for patients with moderate and severe pain, either in improving the QOL of cancer pain patients when used together with WHO three-step analgestic ladder.

Clinical observation on eyelid herpes zoster with external use ganciclovir ophthalmic gel / 国际眼科杂志(Guoji Yanke Zazhi)

AlM: To observe the treatment efficacy of eyelid herpeszoster with external use ganciclovir ophthalmic gel.METHODS:A total of 77 patients were randomly divided into treatment group and control group. ln the treatment group, ganciclovir ophthalmic gel was topical coated on the basis of antiviral drugs, while the control group was coated with conventional acyclovir ointment and antiviral treatment. RESULTS: The cure rate was 95% in the treatment group, and the control group was 83% after 10d treatment. The difference was significant. CONCLUSlON: The efficacy of ganciclovir ophthalmic gel treated eyelid herpes zoster is obvious.

Analysis of the Utilization of Gynecological Drugs for External Use in Our Hospital During the Period 2005～2007 / 中国药房

OBJECTIVE:To evaluate the utilization of gynecological drugs for external use in our hospital.METHODS:By a retrospective method,the gynecological drugs for external use used in our hospital from 2005 to 2007 were analyzed statistically in respect of the consumption sum,DDDs,DDC,etc.RESULTS:The consumption amount of the gynecological drugs for external use in our hospital remained stable over the 3 years,leading the first three places in terms of consumption sum were suppository,vaginal tablets and lotion,of which,the consumption sum of Chinese formulations and that of the western formulations were about the same.CONCLUSION:The use of the gynecological drugs for external use in our hospital over the 3 years is rational on the whole but remains to be improved further in order to contain the increasingly increased medical treatment cost.

Analysis of Eye Drops for External Use in the Outpatient of Our Hospital Between 2004 and 2006 / 中国药房

OBJECTIVE:To investigate the application structure and tendency of eye drops for external use so as to provide references for the research & development,production and use of this preparation.METHODS:Data including variety,classification,consumption amount and sales volume of the eye drops from 2004 to 2006 in the outpatient were analyzed retrospectively by hospital information system.RESULTS & CONCLUSION:The application structure of eye drops in our hospital was basically stable,but control on the use of anti-infective drugs needs to be tightened;the amount of anti-xeroma and anti-asthenopia drugs increased to a large extent;the imported variety takes an excessively large proportion.The use of anti-infective drugs should be standardized and the market share of domestic drugs remains to be further enlarged.

Skin Susceptibility Test of Jaundice-abating Chinese Herbal Lotion for External Use / 中国药房

OBJECTIVE:To study the safety of Jaundice-abating Chinese Herbal Lotion for External use through animal skin susceptibility test so as to provide references for its clinical application.METHODS:Skin and systemic susceptibility tests were conducted in accordance with the pertinent standards issued by our country.RESULTS:Neither skin allergic reaction nor systemic allergic reactions were noted for jaundice-abating Chinese Herbal Lotion for external use.CONCLUSION:Jaundice-abating Chinese Herbal Lotion for external use meets the clinical requirements in the skin susceptibility test.This drug was proved to be safe in the local or systemic application,and it can be used in the clinic through systemic tub bath.

A Preliminary Study on the Formulation of Prescriptions of Dermatological Preparations for External Use / 中国药房

The therapeutic effects of dermatological preparations for external use are not only dependent on its peculiar pharmacological action of the basis but also closely related to many factors, such as drug concentrations, types of preparation, excipients etc. On the basis of extensively reading the relevant literatures and of author's practical experiences, the above affected faetors were discussed preliminarily.