According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

Aiming at the characteristics of telemedicine service,we summarized our telemedical consultation work during 2006-2008.We believed that telemedical consultation from big hospitals are very important in maintaining physical and moral health conditions and treating severe sickness of grassroots officers and soldiers,it can also play active roles in the construction of basic army unit hospitals.

Garrès osteomyelitis is a specific type of chronic osteomyelitis that most commonly occurs in young patients, secondary to dental infection, and affects the unilateral side of the mandible. Bilateral mandibular Garrè's osteomyelitis is rare. In this article, a case of Garrè's osteomyelitis with bilateral mandible is reported. Its etiology, clinical pathologic features, diagnosis, differential diagnosis, and treatment methods are discussed by reviewing relevant literature.
Chronic Disease ; Diagnosis, Differential ; Humans ; Mandible ; Mandibular Diseases ; Osteomyelitis

In order to summarize and perfect the basic skill practicing method in acupuncture teaching and form a characteristic teaching, the research on skill training and technique improving of acupuncture and tuina major was carried out. The undergraduate students in acupuncture and tuina major from College of Acupuncture-Moxibustion and Tuina were randomly divided into an experimental group and a control group. Students from both groups received the basic courses of acupuncture-moxibustion and tuina as requested in the syllabus and the special teaching was added to the experimental group, namely "three practice" (strength practice, coordination practice, targeted practice of acupuncture basic skills) and "three enlightenment" (technique enlightenment, mind and qi enlightenment, efficacy enlightenment). During and after the courses, the teaching effectiveness was evaluated on the basis of needling manipulation. The peacetime score in the experimental group was superior to that in the control group (38.03 +/- 1.14 vs 33.25 +/- 1.31, P < 0.05), the total score in the experimental group was superior to that in the control group (84.03 +/- 6.30 vs 78.05 +/- 6.55, P < 0.05). The special teaching method of "three practice" and "three enlightenment" can improve the effect of skill training teaching method. It highlights the unique feature of central plains by integrating the essence of Shaolin internal qigong and Chen-style Taiji, it can also provide new ideas for the practical teaching of TCM professional courses and the construction of characteristic professionals.
Acupuncture ; education ; manpower ; Acupuncture Therapy ; methods ; Humans ; Students ; Teaching

No abstract available.
Gastrins*

BACKGROUND:Cryopreservation of human umbilical cord mesenchymal stem cel s has been a hot research issue currently, but the studies concerning their effects on expansion of hematopoietic stem/progenitor cel s after cryopreservation are seldom. OBJECTIVE:To investigate the effects of human umbilical cord mesenchymal stem cel s before and after cryopreservation as feeder layer on expansion of human bone marrow mononuclear cel s in vitro. METHODS:2.5g/L mitomycin C processed human umbilical cord mesenchymal stem cel s and bone marrow mesenchymal stem cel s at passage 3 were used as the feeder layer to expand adult al ogeneic bone marrow mononuclear cel s in culture. Up to day 35, methylcel ulose assay was used to detect hematopoietic stem/progenitor cel colony proliferation. RESULTS AND CONCLUSION:There were no differences in the morphology and size of colonies in the cryopreserved human umbilical cord mesenchymal stem cel group, bone marrow mesenchymal stem cel group and non-cryopreserved human umbilical cord mesenchymal stem cel group. However, these parameter described above were significantly higher in these three groups than the blank control group (P<0.05). There were fewer colonies in the cryopreserved human umbilical cord mesenchymal stem cel group than the non-cryopreserved human umbilical cord mesenchymal stem cel group (P<0.05). These findings indicate that human umbilical cord mesenchymal stem cel s before and after cryopreservation have the ability as feeder layer on expansion of bone marrow mononuclear cel s in vitro similar to bone marrow mesenchymal stem cel s. But this ability of human umbilical cord mesenchymal stem cel s may decrease after cryopreservation.

Abstract: Objective To explore and analyze the diagnostic value of multicolor melting curve analysis (MMCA) for the resistance of five anti-tuberculosis drugs, so as to clarify the clinical value of MMCA in detecting drug resistance of Mycobacterium tuberculosis. Methods From April 2021 to May 2022, 200 patients with positive Mycobacterium tuberculosis admitted to the Fourth People's Hospital of Qinghai Province were selected as research objects, and sputum specimens were taken from the patients. Traditional Mycobacterium tuberculosis drug sensitivity test (modified Löwenstein-Jensen medium method) and MMCA analysis were respectively given to detect the resistance of five anti-tuberculosis drugs, including isoniazid, ethambutol, streptomycin, rifampicin and isoniazid, respectively. Those samples with inconsistent results between the two diagnosis methods were subjected to gene sequencing verification, and the diagnosis efficiency of MMCA for the five anti-tuberculosis drugs was compared. Results Using Mycobacterium tuberculosis drug sensitivity as the gold standard for drug resistance diagnosis, the sensitivity of MMCA for detecting drug resistance of rifampicin, ethambutol, streptomycin, isoniazid and levofloxacin were 95.83% (46/48), 93.75% (15/16), 100.00% (15/15), 100.00% (20/20) and 70.00% (7/10), respectively, with statistical differences between groups (P<0.05). There were no statistically significant differences in the specificity, positive predictive value, negative predictive value and accuracy of MMCA for the five anti-tuberculosis drugs (P>0.05). For the 8 samples with inconsistent results between MMCA and modified Löwenstein-Jensen medium method, gene sequencing was performed and compared with the results of gene sequencing. After comparison with gene sequencing results, it was found that the coincidence rate of MMCA and gene sequencing results was 75.00% (6/8). Conclusions In the detection of drug-resistant mutations in TB patients, multi-color probe fusion curve analysis has high diagnostic efficacy for first-line anti-tuberculosis drugs, but is not sensitive to second-line anti-tuberculosis drug levofloxacin. Therefore, for the detection of first-line anti-tuberculosis drugs, MMCA has a good clinical application prospect.

The aim of this study was to investigate the effect of Bu-Shen-An-Tai recipe (BSATR) and its two components (Bushen recipe, and Huoxue recipe) on endometrial morphology during peri-implantation in superovulated mice. Mice were randomly divided into five groups, including the normal (N), model (M), Bushen (BS), Huoxue (HX) and Bu-Shen-An-Tai (BH) groups. The uteri were collected on day 4 of pregnancy, and the endometrium thickness, microvessel density (MVD) and number of pinopodes observed. Compared with the M group, the endometrial thickness in the BS, HX and BH groups was significantly increased and there was a significant difference in endometrial thickness between the BS and the BH groups. The mean MVD was significantly lower in the M group than in the N group, and there was a significant increase in MVD in the BS, HX and BH groups as compared with the M group. Compared with the M group, the pinopode scores in the endometrium were significantly increased in the HX and BH groups; and the BS group had significantly higher pinipode scores than the HX and BH groups. In conclusion, the results of the present study demonstrated that the recipes (Bushen, Huoxue and BSATR) could improve the endometrial environment by regulating the endometrial thickness, MVD and the number of pinopodes at the window of implantation. Moreover, the Huoxue recipe and the BSATR were more efficient than the Bushen recipe, with the BSATR tending to have the most beneficial effects.

To explore the growth and development and analyze the quality of the parthenocarpy fruit induced by exogenous hormones of Siraitia grosvenorii. the horizontal and vertical diameter, volume of the fruit were respectively measured by morphological and the content of endogenous hormones were determined by ELISA. The size and seed and content of mogrosides of mature fruit were determined. The results showed that the fruit of parthenocarpy was seedless and its growth and development is similar to the diploid fruit by hand pollination and triploid fruit by hand pollination or hormones. But the absolute value of horizontal and vertical diameter, volume of parthenocarpy fruit was less than those of fruit by hand pollination, while triploid was opposite. The content of IAA, ABA and ratio of ABA/GA was obviously wavy. At 0-30 d the content of IAA and ABA of parthenocarpy fruit first reduced then increased, content of IAA and GA parthenocarpy fruit was higher than that of fruit by hand pollination. Mogrosides of parthenocarpy fruit was close to pollination fruit. Hormones can induce S. grosvenorii parthenocarpy to get seedless fruit and the fruit shape and size and quality is close to normal diploid fruit by hand pollination and better than triploid fruit by hormone or hand pollination.
Cucurbitaceae ; chemistry ; drug effects ; genetics ; growth & development ; Diploidy ; Fruit ; chemistry ; genetics ; growth & development ; Plant Growth Regulators ; pharmacology

Objective:To observe the effect of herbal cake-partitioned moxibustion on the expressions of mitogen-activated protein kinase (MEK1/2) and extracellular regulatory protein kinase (ERK1/2) in gastric tissues of rats with spleen deficiency syndrome, and to explore the possible mechanisms of herbal cake-partitioned moxibustion in treating spleen deficiency syndrome. Methods:Sixty Sprague-Dawley (SD) rats were randomly divided into a blank control group (group A), a model group (group B), a ranitidine group (group C), and a herbal cake-partitioned moxibustion group (group D) by random digit, 15 rats in each group. Rat models of spleen deficiency syndrome were made by intragastric administration of 4℃ 200% concentrated Da Huang (Radix et Rhizoma Rhei). After successful modeling, the rats in group C were treated with 25 mg/(kg·bw) ranitidine by intragastric adminstration and rats in group D were treated with herbal cake-partitioned moxibustion at Zusanli (ST 36) and Zhongwan (CV 12), for 8 d. Excepted for rats in group A, all the other rats were treated with indomethacin at 5 mg/(kg·bw) at 8:00 a.m. on the second day after finishing all the intervention and sacrificed 7 h later to isolate the stomach. Histopathological changes of the gastric tissues were observed under light microscope after hematoxylin-eosin (HE) staining. The protein expressions of MEK1/2 and ERK1/2 in the gastric tissues were detected by immunohistochemistry. Results:After intervention, the gastric mucosal injury in group B was significantly severer than that in group A, with large breakage and ablating; the damage of gastric mucosa was decreased in group C compared with group B; the gastric mucosal surface remained relatively complete, and the status of breakage and ablating was significantly improved. After intervention, compared with group A, the protein expressions of MEK1/2 and ERK1/2 in gastric tissues of the other groups were significantly higher (P<0.01). Compared with group B, the protein expressions of MEK1/2 and ERK1/2 in group C and D were significantly higher (allP<0.01). Compared with group C, the protein expressions of MEK1/2 and ERK1/2 in group D were significantly higher (P<0.01). Conclusion: Herbal cake-partitioned moxibustion promotes the repair of gastric mucosa in rats with spleen deficiency syndrome, via improving protein expressions of MEK1/2 and ERK1/2 in gastric tissues, as well as activating MEK/ERK signaling pathway.