1.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
2.Taste masking pharmaceutical excipients and their applications
Xiang-an-ni KONG ; Lei ZHAO ; Wen-zhen ZHAN ; Yu-xuan LI ; Chang LI ; Jia-sheng TU ; Chun-meng SUN
Acta Pharmaceutica Sinica 2023;58(11):3179-3184
The taste of drugs has an important impact on the compliance of patients, but most of the active drug ingredients have an uncomfortable taste, especially traditional Chinese medicine. Through a variety of pharmaceutical excipients with taste masking properties combined with corresponding technologies can improve the taste of drugs and the characteristics of other dosage forms, so as to improve patient compliance. Here, we mainly summarize the auxiliary materials used for taste masking, explain the mechanism of taste masking from the point of view of excipients and introduces related uses, so as to provide reference for further research on taste masking of pediatric preparations.
3.Textual Research on Nelumbinis in Famous Classical Formulas
Hui-hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):42-54
The name, origin, place of origin, medicinal parts, harvesting and processing of lotus are verified by consulting ancient Chinese herbal medicines and medical books, combined with modern literature, providing a basis for the development of famous classical formulas containing lotus. According to textual research, the original base of lotus is Nelumbo nucifera since ancient times, rhizome (Nelumbinis Rhizomatis Nodus), leaf (Nelumbinis Folium), seed (Nelumbinis Semen), embryo (Nelumbinis Plumula), receptacle (Nelumbinis Receptaculum), stamen (Nelumbinis Stamen) and other medicinal parts of N. nucifera can be used as medicine and have different clinical effects. Nelumbinis Semen was originally produced in Henan, and then gradually expanded to Jiangnan. Today, it can be cultivated and planted throughout the country, with Fujian, Hunan, and Jiangxi as the authentic production areas. After combing the medicinal parts of N. nucifera and the historical evolution of its processing, it is suggested that the dried and mature fruits of N. nucifera taking in autumn and removing the shell and Nelumbinis Plumula should be used in Qingxin Lianziyin. Nelumbinis Folium in Erdongtang should be harvested in summer and autumn, and the raw products was used as medicine and processed in accordance with the provision of the 2020 edition of Chinese Pharmacopoeia.
4.Textual Research on Perillae in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui -hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):55-67
Based on the ancient literature of all dynasties, this article makes a systematic textual research on the name, origin, producing area, quality, harvesting and processing of Zisu (Perillae) in the famous classical formulas, so as to clarify the information of the drug in different historical periods and provide a reference for the development and utilization of the related formulas. The main origin of Perillae in the ancient literature was Perilla frutescens var. frutescens (purple leaf type), followed by P. frutescens var. acuta (purple leaf type), but not Baisu. Modern chemical composition studies also show that there are obvious differences between Perillae and Baisu, which provides a scientific basis for distinguishing them. Although they are often treated as a species in plant classification, P. frutescens var. frutescens (purple leaf type) is recommended in the development of famous classical formulas, and Baisu should be avoided. Perillae is widely distributed, but its producing area did not record in most of the literature in the past dynasties, or the producing area is described as everywhere today. In the period of the Southern and Northern dynasties, the medicinal parts of Perillae included stems, leaves and seeds, and doctors in the Ming dynasty began to pay attention to the differentiation of different medicinal parts. The harvesting and processing methods of Perillae in the past dynasties are close to that of today. Perillae Fructus is mostly stir-fried and ground into medicine, Perillae Folium and Perillae Caulis are mainly simple cleansing. In production, we can refer to the 2020 edition of Chinese Pharmacopoeia.
5.Herbal Textual Research on Dendrobii Caulis in Famous Classical Formulas
Ju-run ZHAO ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):215-228
Through consulting the ancient herbal and medical books, combined with the field investigation, the name, origin, collection and processing of Dendrobium medicinal materials were researched, which provided a basis for the development of famous classical formulas containing this kind of herbs. Due to the wide distribution of D. officinale, the Dendrobium species represented by D. officinale and D. huoshanense, which are short, fleshy and rich in mucus, should be the most mainstream of Dendrobium medicinal materials in previous dynasties. Compared with Shihu, Muhu with loose texture, long and hollow is born on trees. According to the characteristic description, it should be D. nobile, D. fimbriatum and so on, of which D. nobile was the mainstream. The Chinese meaning of Jinchai was confused in the past dynasties, so it was not suitable to be treated as a plant name. The production areas of Dendrobium medicinal materials in the past dynasties have changed with the discovery of varieties, artificial cultivation and other factors. Lu'an, Anhui province, was the earliest recorded in the Han and Wei dynasties. Since the Tang and Song dynasties, it had been extended to Guangdong and Guangxi, and it was considered that "Dendrobii Caulis in Guangnan was the best". In the Ming dynasty, Sichuan and Zhejiang products were highly praised, and in the Qing dynasty, Huoshan products were highly praised. Dendrobium medicinal materials had been used as medicine by stems in all dynasties. The medicinal materials were divided into fresh products and dry products. The fresh products can be used immediately after removing the sediment from the roots. The dry products need further processing, most of them used wine as auxiliary materials for steaming, simmer to paste or decoction into medicine. D. officinale and D. huoshanense have special processing specifications since the middle of Qing dynasty, that is, "Fengdou". According to the research results, in Ganluyin, the effect of Dendrobium medicinal materials is mainly heat clearing, and D. nobile with bitter taste can be selected. The main effect of Dendrobium medicinal materials in Dihuang Yinzi is tonic, D. officinale or D. huoshanense can be selected.
6.Herbal Textual Research on Alismatis Rhizoma in Famous Classical Formulas
Yi-han WANG ; Jia-chen ZHAO ; Qian-qian WENG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):229-237
In this study, name, origin, producing areas, harvesting time and processing methods of ancient Alismatis Rhizoma were systematically researched by consulting the literature of ancient herbs, medical and prescription books, so as to provide a basis for the development of famous classical formula containing this herb. According to textual research, the main base of ancient Alismatis Rhizoma was Alisma plantago-aquatica and A. orientale. A. canaliculatum and A. gramineum and other genera were sometimes used as the source of Alismatis Rhizoma, there was a confusion of medicinal varieties. The earliest producing area of Alismatis Rhizoma was in today's Henan province, and later Hanzhong, Shaanxi province, became the high-quality producing area of Alismatis Rhizoma. Since the Ming dynasty, its production area expanded to Fujian. In the Qing dynasty, Jian'ou in Fujian was the authentic production area of Alismatis Rhizoma. In the period of the Republic of China, Sichuan and Jiangxi were added to the production areas of Alismatis Rhizoma. Based on the research results, it is suggested that the dried tubers of A. orientale from Fujian and Jiangxi or A. plantago-aquatica from Sichuan should be used in the famous classical formulas. In ancient times, Alismatis Rhizoma was processed by wine, but most of the standards and specifications in modern times are no longer included the processing specifications of Alismatis Rhizoma with wine. Although salt-processed Alismatis Rhizoma is commonly used in modern times, it didn't become one of the main processing methods until the Qing dynasty. According to the relevant national documents, it is suggested that Alismatis Rhizoma without clear processing requirements in famous classical formulas should be used as raw products, and the formulas with processing requirements should be selected as processed products such as salt and wine according to the meaning of the formulas.
7.Herbal Textual Research on Bambusae Caulis in Taenias in Famous Classical Formulas
Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):238-246
By consulting the ancient herbal and medical books, combined with modern literature, the name, origin, geoherbalism, harvesting and processing changes of Bambusae Caulis in Taenias in famous classical formulas were sorted out. According to the research, ancient doctors only approved three kinds of bamboo medicinal materials, namely, Jinzhu (䈽竹), Kuzhu (苦竹) and Danzhu (淡竹), and took bamboo leaves, made Bambusae Caulis in Taenias and Zhuli (竹沥) for medicine. Bamboo medicinal materials with different origins have different properties, tastes and effects, after clinical optimization, it is gradually considered that Danzhu is the best source of Bambusae Caulis in Taenias and Zhuli. According to the morphological description of the original plants and the attached drawings, it is considered that the Danzhu in ancient Chinese materia medica should be Phyllostachys nigra var. henonis, which has been included in the 2020 edition of Chinese Pharmacopoeia as one of the genuine sources of Bambusae Caulis in Taenias. Therefore, It is suggested that P. nigra var. henonis can be added as the source of Bambusae Caulis in Taenias in famous classical formulas, and the medicinal part is the dry middle layer of its stem. Ginger-processed can increase the anti emetic effect of Bambusae Caulis in Taenias, and the three formulas involving Bambusae Caulis in Taenias from The Catalogue of Ancient Famous Classical Formulas (The First Batch) all contain ginger, and the processing method of Bambusae Caulis in Taenias is not marked in the original formula, so it is suggested to use raw products in the three formulas of Jupi Zhurutang, Wendantang and Zhurutang.
8.Herbal Textual Research on Chuanxiong Rhizoma in Famous Classical Formulas
Yi-han WANG ; Jia-chen ZHAO ; Yan JIN ; Hui-hui LIU ; Shi-bin CHEN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):262-274
Based on various ancient documents such as materia medica, prescription books, classics and history, combined with relevant research materials in modern times, this paper made a textual research on the name, origin, geoherbalism, harvesting time, processing methods of Chuanxiong Rhizoma, which provides a basis for the development of famous classical formulas containing this herb. According to the textual research, the original name of Chuanxiong is Xiongqiong (芎䓖), which was first recorded in Shennong Bencaojing , there are many aliases and trade names in the past dynasties. Since the Song dynasty, doctors all take Xiongqiong produced in Sichuan as the best medicine, so they take Chuanxiong as the rectification of name. In the early stage, the origin of Chuanxiong Rhizoma was relatively complicated, and the main origin was Ligusticum chuanxiong, which was a cultivated and domesticated species of Ligusticum. However, wild related plants of Ligusticum are still used as medicine. After the Ming dynasty, new cultivated varieties appeared in various places, such as Jiangxi L. sinense cv. Fuxiong, which gradually turned to self-production and self-marketing after the Republic of China. After several changes in the authentic producing area of Chuanxiong Rhizoma, Tianshui in Gansu province was highly praised in the Tang dynasty, and Dujiangyan in Sichuan province was the best place in the Song dynasty and later dynasties. Chuanxiong Rhizoma has been widely used in the past dynasties as raw products, and it has also been processed with excipients. For example, wine-processed products can enhance the effect of promoting blood circulation, promoting Qi circulation and relieving pain. There are other processing methods such as stir-frying and vinegar processing. Chuanxiong Rhizoma in the famous classical formulas can be selected according to this research conclusion.
9.Herbal Textual Research on Jujubae Fructus in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui-hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):296-305
This paper made a systematic textual research on the historical evolution and changes of the name, origin, producing area, harvesting and processing methods of Jujubae Fructus used in famous classical formulas by referring to the ancient literature, so as to provide a basis for the sampling and research of the formulas containing the medicinal materials. According to textual research, there are many names of Jujubae Fructus, most of which are named by characters or producing areas, which are called Dazao. Ziziphus jujuba has always been the mainstream variety in all dynasties, and Z. jujuba var. inemmis has also been used. Considering that the differences between the two are not obvious, we can use Z. jujuba and Z. jujuba var. inemmis as the origins of Dazao. The germplasm resources of Jujubae Fructus are rich, which are distributed all over the country. Qingzhou (now Shandong), Jinzhou (now Shanxi) Jiangzhou (now Shanxi), Puzhou (now Shanxi) have been recorded as authentic producing areas of Jujubae Fructus in the past dynasties, especially in Shandong. At the beginning of the 21st century, the planting of Jujubae Fructus in Xinjiang gradually developed, and now has a high market recognition, becoming an emerging production area of high-quality samples. Harvest period of Jujubae Fructus is mostly August in the past dynasties, and this is basically the same as today. The main processing method is simple cleansing and drying. Through textual research, it is suggested that Jujubae Fructus in famous classical formulas should be mainly from Shandong, Shanxi and other traditional high-quality producing areas, the processing method should follow the 2020 edition of Chinese Pharmacopoeia for simple cleansing and drying.
10.Herbal Textual Research on Magnoliae Officinalis Cortex in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui-hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):306-317
Based on the ancient literature of all dynasties, this article makes a systematic textual research on the name, origin, producing area, quality, harvesting and processing of Magnoliae Officinalis Cortex used in the famous classical formulas, and clarifies its information of each link in different historical periods, so as to provide a reference and basis for the development and utilization of the related formulas. The results showed that the main varieties of Magnoliae Officinalis Cortex were Magnolia officinalis or M. officinalis var. biloba. The main production areas are Hubei, Sichuan, Chongqing and other places, forming the famous authentic medicine. The processing methods of the past dynasties are mainly cleansing and processing with ginger. In the formulas clearly marked with ginger processing, ginger-processed products is suggested to choose. If not clearly marked, raw or ginger-processed products can be used as needed.

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