In this study, fluvoxamine maleate sustained-release pellet system tablets were prepared and were used to evaluate their release behaviors in vitro. Fluvoxamine maleate pellets were prepared using centrifugal-spherization method and coated by fluidized bed as bottom-spray. The multi-unit sustained-release pellets and appropriate excipients for prescription volumes were mixed uniformly and then compressed to tablets. Screening and determining the optimal formulation of drug loaded pellets through L8 (2⁴) Taguchi experiment. Using Minitab software to design a DOE experiment with 2⁴ partial factors, including material temperature, fan speed, atomization pressure, and spray rate to optimize the bottom spray coating process. Taking monostearate glycerol ester with a particle size of 24-40 mesh as the main diluent for tableting to relieve the delamination phenomenon between pellets and excipients during tablet pressing and reduce mechanical damage to the coating film. By examining the powder fluidity indexes such as angle of repose, bulk density, tapped density, and Hausner ratio of mixed particles, it was found that the flowability and compressibility are good and suitable for direct compression. Evaluate the basic properties of the sustained-release tablets, investigate the in vitro release behavior and study the release mechanism. The results of in vitro release test showed that the self-made sustained-release tablets could disintegrate into independent pellet units in phosphate buffer at pH 6.8 and release slowly within 24 h, which conformed to the first-order drug release model. The fluvoxamine maleate sustained-release pellet system tablets meet the requirements of preparation design and has a great commercial prospect.

To date, there is little information about the demography of vasectomy reversal (VR) patients or the factors currently influencing VR effectiveness in China, especially after the universal two-child policy was released in 2015. In this research, demographic data and perioperative medical records of VR patients were extracted from seven major hospitals in different provinces or municipalities of China. Meanwhile, a telephone survey of the patients was conducted to collect follow-up information. Eventually, 448 VR cases from the past 13 years were included. The results were analyzed by stratified comparison to investigate factors that can influence postoperative vas deferens patency and pregnancy rate. Appropriately statistical methods were used, and all of the protocols were approved by the Ethics Committees of the institutes in this research. The results showed that the annual operation volume of VR quadrupled after the two-child policy was implemented. Nonmicrosurgery and a long duration of vasectomy were significantly associated with a lower patency rate. A follow-up survey showed that the general postoperative pregnancy rate was 27.2%. For female partners over the age of 35 years, the postoperative pregnancy rate showed a more severe decline, but only 35.5% of them had been given a fertility examination before their husbands' VR surgery. Our work revealed that more patients in China have been demanding VR in recent years. High-quality microsurgery and a short duration of vasectomy are crucial for restoring patency by VR. Clinical andrologists should perform a preoperative fertility evaluation of the patients' female partners.
Male ; Pregnancy ; Humans ; Female ; Adult ; Vasovasostomy ; Retrospective Studies ; Vas Deferens/surgery* ; Vasectomy ; China/epidemiology*

OBJECTIVE: To observe the effect of electroacupuncture on motor function and muscle state in patients with primary osteoporosis (POP). METHODS: A total of 60 female patients with POP were randomized into an observation group (30 cases, 1 case dropped off) and a control group (30 cases, 1 case dropped off). On the basis of adjusting lifestyle, caltrate was given orally in the control group, 2 pills a day for 4 weeks. On the basis of the treatment in the control group, electroacupuncture was applied at Zusanli (ST 36), Yanglingquan (GB 34), Ganshu (BL 18), Pishu (BL 20), Shenshu (BL 23), etc. in the observation group, with disperse-dense wave of 2 Hz/10 Hz in frequency, once every other day, 3 times a week for 4 weeks. The time of timed up-and-go test (TUGT) and the value of 10 m maximal walking speed (10 m MWS) before and after treatment were compared in the two groups, and the Young's modulus values of bilateral multifidus muscles in prone position and sitting position before and after treatment were compared by real-time shear wave elastography (SWE) in the two groups. RESULTS: After treatment, the TUGT time was decreased compared before treatment in the observation group (P<0.01), and that in the observation group was shorter than the control group (P<0.01). After treatment, the value of 10 m MWS test was increased compared before treatment in the observation group (P<0.05). After treatment, the Young's modulus values of bilateral multifidus muscles in prone position and sitting position were increased compared before treatment in the observation group (P<0.01); except for the left side in sitting position, the Young's modulus values of multifidus muscles in the observation group were higher than those in the control group (P<0.01, P<0.05). CONCLUSION On the basis of oral caltrate, electroacupuncture can improve the motor function and muscle state in patients with POP.
Acupuncture Points ; Electroacupuncture ; Female ; Humans ; Life Style ; Osteoporosis/therapy* ; Paraspinal Muscles

OBJECTIVE: To evaluate the effects of auricular acupoint bloodletting (AB) and auricular acupressure (AA) on sleep quality and the levels of melatonin (MT), glutamic acid (Glu), and γ -aminobutyric acid (GABA) in college students with primary insomnia, and to explore the possible mechanism. METHODS: Totally 74 college students at Hebei University of Chinese Medicine with primary insomnia were selected from October 2019 to October 2020. All patients were assigned to AB+AA group (37 cases, received combination of AB and AA) and AA group (37 cases, received only AA on the same acupoints) by a random number table. Each group was treated twice a week for 4 weeks. The Pittsburgh Sleep Quality Index (PSQI) score, Chinese medicine (CM) syndrome score, total effective rate, serum concentrations of MT, Glu, and GABA, and Glu/GABA ratio were compared between the two groups after treatment and at follow-up. The safety of therapy was also evaluated. RESULTS: After 4-week treatment, the total scores of PSQI, each PSQI component score, and the CM syndrome scores in both groups all decreased (P<0.05); the serum MT concentrations in both groups all increased (P<0.05). The concentrations of Glu and GABA in the AB+AA group were significantly higher than those in the AA group after treatment (P<0.05). However, there was no significant difference in the ratio of Glu/GABA in both groups before and after treatment (P>0.05). At follow-up, the CM syndrome score in the AB+AA group was significantly lower than that in the AA group (P<0.05). There was no significant difference between the two groups in total effective rates and adverse events (P>0.05). CONCLUSIONS Both AB+AA and AA can relieve insomnia symptoms, but a stronger long-term effect were observed for AB+AA. AB+AA can promote the secretion of MT, increase the levels of Glu and GABA more effective than AA, and regulate their imbalance, and thus it may be benificial for treating insomnia.
Humans ; Acupressure ; Acupuncture Points ; Bloodletting ; Sleep Initiation and Maintenance Disorders/therapy* ; Sleep Quality ; Syndrome ; Students ; gamma-Aminobutyric Acid

BACKGROUND: Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment. METHODS: This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles (and up to eight cycles). The primary endpoint was the overall response rate (ORR); and secondary endpoints were duration of response (DoR), progression-free survival (PFS), safety, and pharmacokinetics. Patients were classified according to their best overall response after initiation of therapy. Proportions of patients in each response category (complete response [CR], partial response [PR], stable disease, or progressive disease) were summarized along with a two-sided binomial exact 95% confidence intervals (CIs) for the ORR. RESULTS: A total of 102 patients were enrolled from 20 centers between August 6th, 2012, and June 18th, 2015. At the time of the primary analysis, the ORR was 73% (95% CI: 63%-81%) per Independent Review Committee (IRC) including 19% CR and 54% PR. With the follow-up period, the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment; the median PFS was 18.6 months and 15.3 months, respectively. The most common non-hematologic adverse events (AEs) were gastrointestinal toxicity, pyrexia, and rash. Grade 3/4 neutropenia was reported in 76% of patients. Serious AEs were reported in 29 patients and five patients died during the study. Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities. CONCLUSION: Bendamustine is an active and effective therapy in Chinese patients with relapsed, indolent B-cell NHL, with a comparable risk/benefit relationship to that reported in North American patients. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, No. NCT01596621; https://clinicaltrials.gov/ct2/show/NCT01596621.
Adult ; Antineoplastic Combined Chemotherapy Protocols ; Bendamustine Hydrochloride/therapeutic use* ; China ; Humans ; Lymphoma, Non-Hodgkin/drug therapy* ; Neoplasm Recurrence, Local/drug therapy* ; Prospective Studies ; Rituximab/therapeutic use*

Traditional Chinese medicine (TCM) preparations have made tremendous progresses in modernization, whereas there exist relatively few researches pertaining to preparation structures. As demonstrated by the theory and practice of structure pharmaceutics, the structure properties of dosage forms have significant influences on the quality and efficacy of drugs, which might offer reference for the research and development of TCM dosage forms. With the application of synchrotron radiation X-ray micro-computed tomography (SR-μCT) and other novel technologies in recent years, researches in structure pharmaceutics have made huge advancement, which provide reference and methodology basis for the study of TCM preparations. The article generalized and summarized the recent progresses and methods in the structure researches of pharmaceutics and TCM preparations, and further explored the significance of the researches of structure of TCM preparations. It is expected to provide the basis for the dosage form design, production process improvement, and quality evaluation of TCM and promote the modernization of TCM preparations.

The sustainable use of medicinal plants is the foundation of the inheritance of traditional Chinese medicine(TCM) and the acquisition of information on medicinal plants is the basis for the development of TCM. The traditional methods of investigating medicinal plant resources are disadvantageous in strong subjectivity and poor timeliness, making it difficult to real-time monitor medicinal plant resources. In recent years, remote sensing technology has become an important means of obtaining information on medicinal plants. The application of this technology has made up for the shortcomings of traditional methods. The open-access remote sensing data with medium spatial resolution satellites provide an opportunity for extracting information on medicinal plant resources. This study firstly introduced the principles of remote sensing technology, summarized the satellites and the parameters commonly used in the field of medicinal plant resources, and compared the survey methods of remote sensing technology with traditional methods. Secondly, it reviewed the applications of remote sensing technology in the extraction of information on the cultivation of medicinal plants and the common methods for extracting the planting structure information of medicinal plants based on remote sensing technology. Thirdly, the applications of remote sensing technology in the investigation and monitoring of medicinal plants were further analyzed with the research objects divided into wild and cultivated medicinal plants according to the characteristics of the habitats. Finally, it pointed out the key unsolved technical problems in the remote sensing monitoring of medicinal plant resources, and proposed solutions for the intelligent information processing of medicinal plants based on remote sensing big data, which is expected to provide references for the development of remote sensing technology in derivative application in medicinal plant resources.
Medicine, Chinese Traditional ; Plants, Medicinal ; Remote Sensing Technology

OBJECTIVE: To compare the therapeutic effect of thunder-fire moxibustion combined with vibration training and simple vibration training on low back pain of primary osteoporosis by 's modulus of ultrasonic wave, and seek an objective evaluating method. METHODS: A total of 60 patients were randomized into an observation group and a control group, 30 cases in each one. The patients in the two groups were treated with vibration training using whole body vibration treatment bed. In the observation group, thunder-fire moxibustion was applied at Yaoyangguan (GV 3), Mingmen (GV 4), Ganshu (BL 18), Shenshu (BL 23) and Dachangshu (BL 25). The treatment was given once every other day, 3 times a week for 4 weeks. The visual analogue score (VAS), real-time shear wave elastography (RTSWE) and medical outcomes study 36-item short-form hearth survey (SF-36) were used to evaluate pain intensity, multifidus muscle tone ('s modulus) and quality of life before treatment, after 4-week treatment and 1 month after treatment. RESULTS: Compared before treatment, the VAS scores, 's modulus of multifidus muscle and 5 dimensions of SF-36 (physical condition, body pain, general health, social function and mental health) after 4-week treatment and 1 month after treatment were significantly improved in the two groups (all <0.05), the physiological role in the observation group after 4-week treatment and 1 month after treatment were improved (both <0.05). In the observation group, the VAS scores, 's modulus of multifidus muscle and 3 dimensions of SF-36 (physiological role, body pain and general health) after 4-week treatment and 1 month after treatment were superior to the control group (all <0.05). CONCLUSION The therapeutic effect of thunder-fire moxibustion combined with vibration training is superior to simple vibration training in relieving low back pain intensity and multifidus muscle tone, and improving quality of life for primary osteoporosis. RTSWE technique can be an objective examination method to evaluate pain.
Acupuncture Points ; Humans ; Low Back Pain ; etiology ; therapy ; Moxibustion ; Osteoporosis ; complications ; Quality of Life ; Treatment Outcome ; Vibration

Qizhu, the dried rhizome of Atractylodes macrocephala in Compositae family, is the representative wild variety of Atractylodis Macrocephalae Rhizoma (Baizhu) with modern excellent quality. Through textual research of materia medica works and modern studies, the medication methods between Qizhu and ancient Baizhu were systematically compared. Focusing on seven key issues, this paper systematically summarized the medicinal history, characters, cultivation and other related contents of Qizhu, in order to provide a basis of Qizhu in the recovery and development of its own Daodi-status, and further serve the industrial development of this herb. The name, harvesting time, processing method and other issues had undergone a relatively complicated evolution process. At present, acknowledged points are as following：①The distribution areas of Qizhu include southern areas of the Yangtze River in Anhui province and its surrounding regions. ②Harvesting time is late October. ③Qizhu can be dried in the shade or micro-hot dried after being wrapped with absorbent paper, later it can be divided into two commercial specifications. ④In addition to cutting, there is still a lack of other processing methods. ⑤The superior characters of Qizhu contain white, less oil, fragrant smell and sweet taste and so on. ⑥The history of Qizhu as a genuine medicinal material can be traced back to the Ming dynasty.