The definition of critical quality attributes of Chinese materia medica ( CMM) was put forward based on the top-level design concept. Nowadays, coupled with the development of rapid analytical science, rapid assessment of critical quality attributes of CMM was firstly carried out, which was the secondary discipline branch of CMM. Taking near infrared (NIR) spectroscopy as an example, which is a rapid analytical technology in pharmaceutical process over the past decade, systematic review is the chemometric parameters in NIR model evaluation. According to the characteristics of complexity of CMM and trace components analysis, a multi-source information fusion strategy of NIR model was developed for assessment of critical quality attributes of CMM. The strategy has provided guideline for NIR reliable analysis in critical quality attributes of CMM.
Materia Medica ; standards ; Medicine, Chinese Traditional ; standards ; Spectroscopy, Near-Infrared ; methods

Objective To evaluate the use of double balloon endoscopy(DBE) in diagnosis of ulcerative lesions in small intestine.Methods Data of patients diagnosed as small intestinal ulcer under DBE during September 2003 and December 2007 at Nanfang Hospital were analyzed retrospectively.Results Ulcer in small intestine was detected by DBE in a total of 62 patients,including 48 males and 14 females,aging from 10 to 71 years old( mean 43.9 yr).The main clinical manifestations consisted of small intestinal hemorrhage(38/62,61.3%),abdominal pain(16/62,25.8%),abdominal distention(5/62,8.1%),loss of weight(2/62,3.2%),and diarrhea(1/62,1.6%).The ulcers were diagnosed endoscopically as Crohn's disease(CD) in 53 cases(85.5%),drug induced lesions in 4(6.5%),nonspecific chronic inflammation in 2(3.2%),lymphoma in 2(3.2%) and tuberculosis in 1(1.6%).They were all microscopically diagnosed as chronic inflammation.Of the 62 patients,32(51.6%) underwent surgery.In 30 cases of CD diagnosed by DBE,22 were confirmed by post-surgery pathology(malignant cells were found in 3),while in the other 8 cases,4 were diagnosed as lymphoma,3 as Behcet's disease and 1 as tuberculosis.Meanwhile,the 1 case of tuberculosis and 1 lymphoma diagnosed by DBE were confirmed as CD after operation.The overall accurate diagnosis rate of small intestinal ulcerative lesions by DBE was 68.8%(22/32).Conclusion DBE is valuable in diagnosis of ulcerative lesions in small intestine,but surgery should be included into consideration to confirm the diagnosis when necessary.

Objective To evaluate the effectiveness of single balloon enteroscopy (SBE) in diagno-sing of suspected lesions in small intestine. Methods Data of 23 patients with suspected small intestinal disease, who underwent SBE (Olympus) between February 2009 and August 2009, were retrospectively studied. A total of 34 procedures were performed in 23 patients. The indications for the examination were suspected obscure gastrointestinal bleeding (n = 9), abdominal pain (n = 7), suspected intestinal tumor re-vealed by capsule endoscopy (n = 4), and Crohn disease (n = 3). Results The average preparation time of SBE was less than 5 minutes. The mean procedure time was 61±25 minutes and 67±28 minutes for the oral and anal routes, respectively. Examination of whole length of small intestine was achieved in 6 patients. The diagnostic rate of small-intestinal lesions was 60. 9%, and no severe complications including perforation occurred. Conclusion SBE is safe and easy to prepare and perform, which can be a useful diagnostic and therapeutic tool for suspected small bowel disease.

Objective To investigate the angiographic manifestation of the proper esophageal artery (PEA),the hish risk factom for the presence of the anomalous PEA in hemoptysis and to evaluate the safety of transcatheter aaefial embolization(TAE) of the PEA using gelatin sponge(GS).Methods Selective esophageal arteriography WSS performed in forty-three patients with hemoptysis,including 15 cases of pulmonary tuberculosis,18 cases of bmnchiectasis,7 cases of posttuberculous bronchiectasis and three cases of lung cancer. One case experienced failure of bronchial arterial embolization. The angiographic manifestation of the PEAs Was studied.The complications of the procedure and clinical results were observed in the patients who underwent TAE using GS.Results Thirty-nine PEAs were catheterized selectively in 37 patients(86.0%).Eighteen anomalous PEAs(46.2%)were catheterized selectively in 17 patients (45.9%).The anomalous PEAs showed tortuosity,dilatation,hyperplasia,shunting with pulmonary artery and anastomosis with the bronchial artery.All lesions involved basal segment of inferior pulmonary lobar. Bronchiectasis Was the most frequent disease for PEA abnormality. No complications occurred and satisfactory curative effect Was achieved with TAE of the anomalous PEAs.Conclusions It is necessary to perform selective proper esophageal arteriography when the lesion involves basal segment of inferior pulmonary lobar in hemoptysis.Supplemental TAE of the anomalous PEA using GS is safe and valuable in the management of hemoptysis.

Antibodies, Monoclonal ; administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Breast Neoplasms ; diagnosis ; drug therapy ; metabolism ; pathology ; surgery ; Chemotherapy, Adjuvant ; Cyclophosphamide ; administration & dosage ; Doxorubicin ; administration & dosage ; Female ; Humans ; Neoplasm Recurrence, Local ; Paclitaxel ; administration & dosage ; Receptor, ErbB-2 ; metabolism ; Trastuzumab

Objective To observe the dynamic changes of neuron-specific enolase(NSE)mRNA and protein in offspring rats brain tissue with bilirubin encephalopathy and explore the pathological mechanism and its diagnostic value on bilirubin encephalopathy.Methods Seven-day postnatal Wistar rats were used for study.One hundred and twenty rats were divided into 2 groups randomly(control group and experimental group),which were respectively subdivided into 6 groups(6,12,24,48,72,96 h).The rats in control group were intraperitoneally administered physiological saline 0.5 mL,the rats in experimental groups were intraperitoneally administered bilirubin(200 mg/kg).Reverse transcription-polymerase chain reaction was used to analyze the dynamic changes of NSE mRNA expression at 6,12,24,48,72 and 96 h in brain tissue of rats with bilirubin encephalopathy.Immunohistochemistry was used to evaluate NSE protein expression in hippo-campi,cerebral cortex,thalamic and pallidus at different times.Results The expression of NSE mRNA significantly decreased in brain tissue of rats with bilirubin encephalopathy from 6 h to 96 h compared with the control groups.The expression of NSE protein in hippocampi decreased in offspring rats with bilirubin encephalopathy from 6 h to 96 h,but there were no differences compared with the control groups.The expression of NSE protein in cerebral cortex was significantly decreased in rats with bilirubin encephalopathy from 6 h to 96 h,there were significant differences compared with the control group.The expression of NSE protein in thalamic significantly decreased in rats with bilirubin encephalopathy from 6 h to 96 h,but there were significant differences between experimental groups and the control groups at 24 h and 72 h.The expression of NSE protein in pallidus significantly decreased in offspring rats with bilirubin encephalopathy from 6 h to 96 h,and there were significant differences compared with control groups.Conclusions The changing trends of expression of NSE mRNA were identical to those of NSE protein.NSE may reflect the degree of injury of neurogliocyte.It can serve as reliable index to determine bilirubin encephalopathy.

Objective To set up a system in vitro to rapidly recover plasma proteins lost during artificial-liver treatment.Methods The polyprotein precipitation was obtained by all proteins whose isoelectric point pH value were between 7.3 and 5.1,which collided with each other and aggregated using gradient pH co-precipitation(adding 1 mol/L citric acid slowly in the plasma solution to change the pH values gradually from 7.3 to 5.1 in 5 h)combined with salting out(degree of saturation of NaCl is 33%,reacted for 5.5 h at 4℃)or low-temperature ethanol precipitation(40% ethanol, reacted for 5.5 h at -7℃)so that to get rid of toxicants by discarding the supernatant.Results In the range of pH 5.1-7.3,50%(29g/57g)of the total plasma proteins had been recovered by the gradient pH salting out and 41%(25 g/61g)by the gradient pH low-temperature ethanol co-precipi- tation.The protein remained in the supernatant was mostly albumin and its combined bilirubin.The levels of total bilirubin decreased to 0.07% and 0.06% of the original levels by these two methods respectively and the serum HBV DNA level decreased to be undetected(quantitative PCR).Conclu- sions The proteins with close isoelectric point can co-precipitated with the presence of high concen- tration of NaCl or low-temperature ethanol and by changing the pH value gradually.The total protein in the discarded plasma during artificial-liver treatment can be recovered rapidly using the gradient pH coprecipitation.

Background In recent years,with the contiunous progress of the refractive surgery,the operation skill of phakic intraocular lens(PIOL)implantation for correcting extreme high myopia,astigmatism,farsightedness have made greater progression,and its security,effectiveness in clinical attract much more attention. Objective This study was to evaluate the efficacy,safety and stability of Toric Implantable Collamer Lens(TICL)for extreme high myopic astigmatism. Methods This retrospective case series included 33 eyes of 27 patients from May 2008 to February 2009.A TICL was intraocularly implanted via a 3 mm clear corneal incision after paraocular anesthesia.Patients were examined preoperatively and followed-up at 1 day,1 week,1 month,3,6,12 and 18 months postoperatively.The examinations included uncorrected visual acuity,best corrected visual acuity(BCVA),slit lamp examination,refraction,intraocular pressure,endothelial cell morphometry,etc.The written informed consent was obtained from each patient before any medical procedure. Results The uncorrected visual acuity in 96.97% eyes was equal or improved after operation in comparison with BCVA of preoperation.The spherical refraction was within-1.00 D-+0.25 D.The cylinder refraction was within-1.00 D-0 D.The axial deviation of TICL within 10 degree was 93.94%(31/33).No significant differences were found in the intraocular pressure and endothelial cell morphometry between preoperation and postoperation(intraocular pressure:F=3.35,P=5.49;endothelial cell morphometry:t=1.835,P=0.082).The visual acuity and refraction were stable during the follow-up.Astigmatic axial rotation required surgical intervention on one eye.One eye occurred high intraocular pressure because of bigger TICL diameter.The intraocular pressure returned to normal after TICL was exchanged.No cataract occurred during the follow-up duration. Conclusion TICL implantation appears to be an effective,safe and reliable method for extreme high myopic astigmatism.

Nosocomial infection (NI) is one of the most significant complications arising after open heart surgery,and leads to increased mortality,hospitalization time and health resource allocation.This study investigated the morbidity,mortality,and independent risk factors associated with NI following open heart surgery.We retrospectively surveyed the records of 1606 consecutive cardiovascular surgical patients to identify those that developed NI.The NI selection criteria were based on the Centers for Disease Control and Prevention (CDC) guidelines.The term NI encompasses surgical site infection (SSI),central venous catheter-related infection (CVCRI),urinary tract infection (UTI),respiratory tract infection and pneumonia (RTIP),as well as other types of infections.Of 1606 cardiovascular surgery patients,125 developed NI (7.8％,125/1606).The rates of NI following surgery for congenital malformation,valve replacement,and coronary artery bypass graft were 2.6％ (15/587),5.5％ (26/473) and 13.6％ (32/236),respectively.The NI rate following surgical repair of aortic aneurysm or dissection was 16.8％ (52/310).Increased risk of NI was detected for patients with a prior preoperative stay ≥3 days (OR=2.11,95％ CI=1.39-3.20),diabetes (OR=2.00,95％=CI 1.26-3.20),length of surgery ≥6 h (OR=2.26,95％ CI=1.47-3.47),or postoperative cerebrovascular accident (OR=4.08,95％ CI=1.79-9.29).Greater attention should be paid toward compliance with ventilator and catheter regulations in order to decrease NI morbidity and mortality following cardiovascular procedures.

OBJECTIVETo study the reversibility of di-n-butyl phthalate (DBP) effects on F(1) generation rat testes.

METHODSPregnant rats were treated with different dose of DBP (0, 50, 250 and 500 mg per kg per day) by gavage from GD1 to PND21. The adverse effects of DBP on testes of F(1) male rats in different developmental period (PND14, 21 and 70) were observed by anatomy and pathological methods.

RESULTSThere was no difference in rat testis weight and testis/body weight between DBP-treated group and the control. From the results of pathology and sertoli cell counting, comparing with the control, thinner seminiferous epithelium, decreased cell number and vacuole cells were observed in PND14 male DBP-treated rats. In PND21 rats, the number and form of sertoli cells were recovered and few exfoliated spermatogenic cells were found. When maturing to PND70, few rats were found irreversible damages such as seminiferous tubule degeneration, seminiferous epithelium atrophy, etc.

CONCLUSIONThese results suggest that adverse effects of DBP on young rat testes should be reversibility.

Animals ; Dibutyl Phthalate ; toxicity ; Female ; Male ; Rats ; Rats, Sprague-Dawley ; Sertoli Cells ; pathology ; Testis ; drug effects ; pathology