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

The symbiotic bacterium exists in the intestines of entomopathogenic nematodes and is a potential biological agent.Systematic classification of these bacteria is scarce in China.In this paper,seven strains of symbiotic bacteria from local entomopathogenic nematodes were identified by both observation of mor-phology,physiological,biochemical characteristics and sequence analysis of 16S rDNA fragments.

OBJECTIVETo explore the distribution characteristics of basic syndromes and its related factors in patients with chronic functional constipation (CFC).

METHODSThe complete data of 538 patients with CFC were collected and initial database was established with Epidata 3. 0. TCM syndrome typing was performed. The distribution characteristics of basic syndromes were analyzed using SPSS 17. 0 Software. The univariate and multivariate Logistic regression analyses were performed with SPSS 17. 0 Software to determine basic syndrome related factors such as age, engaged professionals, sleep quality, depression, mental stress, interpersonal relations, work fatigue, stimulating beverage, exercise conditions, Western medicine type of constipation, and so on.

RESULTSThe TCM syndrome frequency of CFC patients was sequenced from high to low as qi deficiency syndrome (380 cases, 70.6%), qi stagnation syndrome (337 cases, 62.6%), blood deficiency syndrome (234 cases, 43.5%), yin deficiency syndrome (220 cases, 40.9%), yang deficiency syndrome (197 cases, 36.6%), and others(58 cases, 10. 8%) . Most patients were complicated with complex syndromes, and the most common complex syndromes were qi deficiency complicated qi stagnation syndrome (275 cases, 51.1%) and qi deficiency complicated blood deficiency syndrome (222 cases, 41.3%). Aging, work fatigue, and exercise conditions were main related factors for qi deficiency syndrome (P <0. 01, P <0. 05). Poor emotional (depression and anxiety tendencies), mental stress, interpersonal relations, defecation barriers constipation were main related factors for qi stagnation syndrome (P <0.01). Sleep quality and poor emotional (depression and anxiety tendencies) were main related factors for blood deficiency syndrome (P <0. 01, P < 0.05). Stimulating beverages were main related factor for yin deficiency syndrome (P <0.05). Engaged in mental work and slow transit constipation were main related factors for yang deficiency syndrome (P < 0. 01, P <0. 05).

CONCLUSIONSCFC is featured as complex syndromes. The most common complex syndromes were qi deficiency complicated qi stagnation syndrome and qi deficiency complicated blood deficiency syndrome. Basic syndrome related factors such as age, engaged professionals, sleep quality, poor emotional (depression and anxiety tendencies), mental stress, interpersonal relations, work fatigue, stimulating beverage, exercise conditions, Western medicine type of constipation were associated with the distribution of CFC syndromes.

Anxiety ; complications ; Constipation ; complications ; diagnosis ; psychology ; therapy ; Depression ; complications ; Diagnosis, Differential ; Factor Analysis, Statistical ; Fatigue ; Humans ; Medicine, Chinese Traditional ; Qi ; Stress, Psychological ; complications ; Syndrome ; Yang Deficiency ; diagnosis ; Yin Deficiency ; diagnosis

OBJECTIVETo investigate the characteristics, diagnosis, and treatment of ovotesticular disorder of sex development (OT-DSD).

METHODSWe retrospectively analyzed 2 cases of OT-DSD treated in our hospital. The patients were 19 and 15 years old, respectively, and both received systematic physical examination and examinations of the karyotype, sex hormone, adrenocorticotropic hormone (ACTH), color Doppler ultrasonography, urethrocystoscopy, and human chorionic gonadotropin (HCG) test. Under the laparoscope, we performed surgical gonad exploration, gonadectomy, and vulvar orthopedics. Intraoperative exploration and pathology confirmed true hermaphroditism in both cases, with sex selection as female. One underwent laparoscopic resection of the ovotestis, and the other removal of the testis with the ovarian tissue reserved.

RESULTSThe patients were followed up for 12 months postoperatively, which found no abnormality in either the vulvas or the genital glands.

CONCLUSIONSurgical exploration of the gonad is the only method for the diagnosis of OT-DSD and sex selection is the key to treatment. Laparoscopic surgical exploration of the gonad and vulvar orthopedics are the first treatment options.

Adolescent ; Chorionic Gonadotropin ; Female ; Gonadal Steroid Hormones ; Humans ; Karyotype ; Laparoscopy ; Male ; Ovary ; Ovotesticular Disorders of Sex Development ; diagnosis ; surgery ; Retrospective Studies ; Testis ; surgery ; Young Adult

Cassiae Semen is a common traditional Chinese medicine, and contents of anthraquinones of Cassiae Semen different significantly from area to area. According to Chinese Pharmacopoeia (2010 edition), only contents of aurantio obtusin and chrysophanol were used to evaluate the quality of Cassiae Semen, another data could be added later. Ten batches of Cassiae Semen from different areas were determined, and total anthraquinones, total free anthraquinones and total combined anthraquinones contents were assessed by ultraviolet visible spectrophotometer, contents of aurantio obtusin, rhein, aloe emodin, emodin, chrysophanol and physcion were determined by HPLC. After that, principal components analysis was used to evaluate these data determined previous by dimension reduction analysis. At last, the result suggests that three main components were found out, it shows that content of aloe emodin could be used to evaluate the quality of Cassiae Semen as well as contents of aurantio obtusin and chrysophanol. And Cassiae Semen from Hebei province posseses higher quality than Cassiae Semen from other different areas. All these results can provide a good reference for quality evaluating of Cassiae Semen medicinal materials at a certain extent.
Anthraquinones ; analysis ; Cassia ; chemistry ; Chromatography, High Pressure Liquid ; Principal Component Analysis

3T3-LI preadipocytes were induced to differentiate and 3T3-L1 adipocyte or preadipocytes were incubated with oleate or palmitate overnight.RT-PCR was used to measure adiponectin receptor(AdipoR)1 and AdipoR2 mRNA levels.The results showed that the AdipoRl and AdipoR2 expressions were differentiation- dependent.Oleate only suppressed AdipoR mRNA expression in preadipocyte but not in adipocyte.However,high concentration of palmitate reduced AdipoR mRNA expression in both 3T3-LI preadipocyte and adipocyte.

In comparison with their in vivo counterparts, the in vitro produced mammalian embryos had markedly lower rates of morula/blastocyst development and pregnancy after transfer to the recipients. Things became even worse in the cloned embryos. This necessitates improvement of the embryo culture system. Co-culture of embryos with different types of somatic cells was found beneficial for embryo development in vitro and many studies have been conducted in this area in recent years. In this paper, recent developments and the authors' own work in studies of co-culture of early mammalian embryos with somatic cells were reviewed, with emphasis on the effects of cell type, stage of estrous cycle and number of passages of somatic cells and supplement of serum on embryo development, and the mechanisms by which co-culture promote embryo development. The recent developments are summarized as follows: 1. Somatic cells of both homogeneous and heterogeneous origins can be used for co-culture of mammalian embryos, with similar developmental rates. 2. Supplementation of animal serum at appropriate concentrations improved the somatic cell growth and consequently the development of embryos in co-culture. 3. The estrous cycle stages of oviduct epithelial cells used for co-culture had no effect on the development of embryos. 4. Over-passaging of somatic cells reduced their efficiency in promoting development of the co-cultured embryos. In conclusion, studies have shown that co-culture overcame the block of embryo development in vitro and improved embryo quality with increased rates of implantation and pregnancy, but many problems remain to be solved on its influencing factors and mechanisms of action.
Animals ; Coculture Techniques ; methods ; Embryo Culture Techniques ; methods ; Embryo, Mammalian ; physiology ; Humans

Amygdala ; drug effects ; metabolism ; Animals ; Conditioning (Psychology) ; Morphine ; adverse effects ; Rats ; Receptors, Opioid, kappa ; metabolism

OBJECTIVETo study the clinical features of neonatal diabetes mellitus (NDM).

METHODThirteen cases with NDM were seen in our department between Jul. 2004 and Sept. 2009. Their clinical features were reviewed retrospectively.

RESULTSThe average birth weight of the 13 cases was 2.30 kg. The median age at diagnosis was 2 months. The mean blood glucose at diagnosis was 22.2 mmol/L. Symptoms in 9 of 13 cases were exacerbated by infection and only 5 had typical symptoms of diabetes mellitus including polydipsia, polyuria, polyphagia and body weight loss. The common clinical findings included athrepsia, diuresis, and moderate dehydration. Ketoacidosis attacked 3 cases and 3 children had hypertriglyceridemia, meanwhile, 2 children had complications of blood clotting dysfunction and congenital cardiopathy, respectively. Autoantibody to insulin (IAA) was tested in 11 cases, all but one case was negative. Glycosylated hemoglobin was increased in 6 cases. Insulin treatment was started in all the 13 cases. The initial dose was 0.56-1.00 U/(kg × d), and the maximal dose was 1.35 U/(kg × d) depending on the variety of blood glucose. Blood glucose decreased significantly within 24 hours. Unfortunately, 1 case developed progressive blood glucose decline and recurrent hypoglycemia. Symptoms of the 3 cases who developed DKA were relieved 48 hours later, and their blood glucose was well under control. Among the 8 cases followed up, 4 had TNDM and 2 had PNDM. Unfortunately, 1 case died at the age of 3 months because insulin injection was stopped by the parents.

CONCLUSIONEarly diagnosis and prompt management may lead to favorable prognosis. Blood glucose monitoring is a valuable method to avoid misdiagnosis and NDM should be differentiated from stress hyperglycemia, iatrogenic, or other causes of hyperglycemia.

Blood Glucose ; analysis ; Diabetes Mellitus ; classification ; drug therapy ; Female ; Humans ; Hyperglycemia ; Infant ; Infant, Newborn ; Male ; Retrospective Studies

OBJECTIVETo evaluate clinical efficacy of suture anchors in treating acute injuries of medial collateral ligament (MCL) of knee at degree III.

METHODSTwenty-seven patients with degree III acute MCL injuries of knee were treated with suture anchors from January 2007 to June 2011. There were 15 males and 12 females, aged from 19 to 56 (averaged 32.6) years old. The time from injury to operation was 3 to 10 days, averaged 6 days. Symptoms and physical signs before and after treatment were observed, Lysholm scoring were used to evluated clinical efficacy.

RESULTSAll patients were followed up from 16 to 30 months with an average of 21.6 months. The stability of knee joints was good in all patients. Abduction stress test was negative when the knee joint was straightened at 0 degrees and flexed at 30 degrees. The average degree of flexed knee (67.00 +/- 5.80) degrees preoperatively was lower than that of postoperatively (136.50 +/- 6.30) degrees at 1 year. According to Lysholm scoring, preoperative scores ranged from 30 to 43 points, averaged 36.46 +/- 1.48; 1 year after operation ranged from 87 to 100 with an average of 91.50 +/- 3.80 and higher than postoperative. Twenty patients got an excellent results, 5 good and 2 fair.

CONCLUSIONSuture anchors in treating acute injuries of medial collateral ligament of knee at degree III has following advantages: small range of tissue dissection, easy to operate, reliable fixation and less complications.

Acute Disease ; Adult ; Collateral Ligaments ; injuries ; surgery ; Female ; Humans ; Knee Injuries ; surgery ; Male ; Middle Aged ; Suture Anchors