Objective: To evaluate the efficacy of Tuina (Chinese therapeutic massage) manipulation plus horse-riding squat exercise in treating knee osteoarthritis (KOA) and optimize the combining protocol. Methods: Based on a 2×2 factorial design, 120 eligible KOA patients were randomized into a manipulation group (group A1B2), a manipulation plus horse-riding squat group (group A1B1), a sitting knee-adjustment group (group A2B2 group), and a sitting knee-adjustment plus horse-riding squat group (group A2B1), with 30 cases in each group. The intervention was conducted three times a week, lasting for four weeks. The Western Ontario and McMaster Universities osteoarthritis index (WOMAC) was taken as the major measure for efficacy evaluation (including three component scores, pain, stiffness, and daily function, and total score). Results: The three component scores (pain, stiffness, and daily function) and the total score of WOMAC showed significant differences after the intervention in the four groups (P<0.05). There were significant inter-group differences in the WOMAC stiffness score amongst the four groups after the intervention (P<0.05). In group A1B1, the step length, stride, walking speed, and knee joint flexion angle changed significantly after treatment (P<0.05). After the intervention, the step length changed significantly in group A1B2 (P<0.05), and the walking speed changed significantly in group A2B1 (P<0.05). There were no significant differences in the step length, stride, walking speed, or knee joint flexion angle among the four groups (P>0.05). The extensor peak torque at 180 °/s changed significantly in group A1B2 after treatment (P<0.05). Neither the intra-group nor the inter-group comparisons of the four groups revealed significant differences in the other isokinetic muscle strength parameters (P>0.05). The main effect of manipulation showed significant in affecting the WOMAC pain and total scores (P<0.05). The main effect of horse-riding squat exercise showed significant in affecting the WOMAC pain and stiffness scores (P<0.05). Conclusion: The four treatment protocols all can improve the symptoms of KOA, for instance, relieving pain and stiffness, and enhancing daily function. Group A2B1 produces the most eminent effect in relieving joint stiffness. The main effects of both manipulation and horse-riding squat exercise are significant in reducing pain. Besides, the main effect of horse-riding squat exercise is significant in relieving joint stiffness.

Design space approach is applied in this study to enhance the robustness of first ethanol precipitation process of Codonopsis Radix (Dangshen) by optimizing parameters. Total flavonoid recovery, dry matter removal, and pigment removal were defined as the process critical quality attributes (CQAs). Plackett-Burman designed experiments were carried out to find the critical process parameters (CPPs). Dry matter content of concentrated extract (DMCE), mass ratio of ethanol to concentrated extract (E/C ratio) and concentration of ethanol (CEA) were identified as the CPPs. Box-Behnken designed experiments were performed to establish the quantitative models between CPPs and CQAs. Probability based design space was obtained and verified using Monte-Carlo simulation method. According to the verification results, the robustness of first ethanol precipitation process of Dangshen can be guaranteed by operating within the design space parameters. Recommended normal operation space are as follows: dry matter content of concentrated extract of 45.0% - 48.0%, E/C ratio of 2.48-2.80 g x g(-1), and the concentration of ethanol of 92.0% - 92.7%.
Chemical Precipitation ; Chemistry, Pharmaceutical ; methods ; Codonopsis ; chemistry ; Drugs, Chinese Herbal ; chemistry ; isolation & purification

OBJECTIVETo compare the incidence of metabolic disorders (MS) in patients with primary aldosteronism (PA) and essential hypertension (EH).

METHODSMS prevalence was observed in 200 EH patients (male 104) and 220 PA patients (male 117) hospitalized to our hospital from August 2005 to March 2007.

RESULTS(1) The prevalence of MS in PA group was significantly higher than that of EH group (47.3% vs. 31.5%, P = 0.009). (2) Blood pressure was significantly higher in PA group than that of EH [SBP: (150.67 +/- 15.45) mm Hg vs. (145.69 +/- 17.13) mm Hg, P = 0.042; DBP: (93.03 +/- 10.51) mm Hg vs. (85.83 +/- 14.44) mm Hg, P = 0.037]. (3) Incidences of abdominal obesity (86.8% vs. 78.5%, P = 0.024) and insulin resistance (insulin sensitivity index: 42.42 +/- 16.11 vs. 49.58 +/- 22.43, P = 0.008) were significantly higher in PA group than in EH group.

CONCLUSIONThe prevalence of MS in hospitalized PA patients was significantly higher than that of EH patients characterized by prevalent abdominal obesity, insulin resistant and severe hypertension.

Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Hyperaldosteronism ; epidemiology ; metabolism ; Hypertension ; epidemiology ; metabolism ; Incidence ; Male ; Metabolic Syndrome ; epidemiology ; Middle Aged

OBJECTIVETo develop an HPLC method to determine the contents of danshensu, hydroxysafflor yellow A, rosmarinic acid, lithospermic acid, salvianolic acid B in the water extract of mixed Salviae Miltiorrhizae Radix et Rhizoma and Carthami Flos simultaneously.

METHODThe separation were carried out at 30 degrees C on a ZORBAX Eclipse Plus C18 column (4.6 mm x 100 mm, 1.8 microm) with formic acid-500 mmol x L(-1) ammonium formate-water solution (0.5:10:90) as mobile phase A and acetonitrile-formic acid solution (100: 0.5) as mobile phase B in gradient mode at a flow rate of 0.5 mL x min(-1). Detection wavelengths were 280 nm for danshensu, rosmarinic acid, lithospermic acid, salvianolic acid B, and 380 nm for hydroxysafflor yellow A.

RESULTThe 5 components were separated well with a good linearity (R2 > 0.999 3) in the range of the test concentration. The average recoveries of danshensu, hydroxysafflor yellow A, rosmarinic acid, lithospermic acid, and salvianolic acid B were 99.1%, 102%, 102%, 98.5% and 101%, respectively.

CONCLUSIONThis method is simple, accurate, and repeatable.

Benzofurans ; analysis ; Chalcone ; analogs & derivatives ; analysis ; Chromatography, High Pressure Liquid ; methods ; Cinnamates ; analysis ; Depsides ; analysis ; Lactates ; analysis ; Quinones ; analysis ; Rhizome ; chemistry ; Salvia miltiorrhiza ; chemistry

Objective: To evaluate the effectiveness of therapeutic massage (tuina) for treating knee osteoarthritis (KOA). Methods: Six English and Chinese databases, including Chinese National Knowledge Infrastructure (CNKI), Wanfang Academic Journal Full-text Database (Wanfang), Chongqing VIP Database (CQVIP), China Biology Medicine Disc (CBM), Cochrane Library and PubMed databases, were independently searched to identify appropriate randomized controlled trials (RCTs) studying therapeutic massage for KOA compared to oral non-steroidal anti-inflammatory drugs (NSAIDs) alone. The main outcome measures were total effectiveness and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score. Results: A total of 8 RCTs were included and they were of average quality. The results showed that therapeutic massage was more effective than NSAIDs comparing total effectiveness [risk ratio (RR)=1.14, 95％ confidence interval (CI) (1.07, 1.21), P<0.0001]; compared with NSAIDs, therapeutic massage produced more significant improvements in pain [mean difference (MD)=-2.06, 95％CI (-2.75, -1.36), P<0.00001], stiffness intensity [MD=-0.90, 95％CI (-1.05, -0.75), P<0.00001] and joint function [MD=-12.48, 95％CI (-13.91, -11.05), P<0.00001]. Conclusion: Therapeutic massage was more effective than oral NSAIDs in treating KOA. In relieving pain and stiffness and improving the function of knee joint, therapeutic massage was superior to NSAIDs.

OBJECTIVEIn recent years, the assessment of the plasma aldosterone-to-renin ratio (ARR) has become a most effectively and commonly used method for screening primary aldosteronism from hypertensive patients. It is known that there is a large variance in ARR value between races and ARR is affected by many factors, such as drugs, posture and serum potassium etc. The objective of this study is to establish the threshold of ARR for screening primary aldosteronism in Chinese hypertensive patients.

METHODSA total of 110 hypertensive patients were recruited and divided into essential hypertension group (n=65) and adenoma/hyperplasia group (n=45) according to the adrenal contrast CT scan. Antihypertensive drugs which can affect ARR such as beta-blockers, dihydropyridine calcium channel blockers (CCBs), ACE inhibitors (ACEIs), angiotensin II receptor blockers (ARBs) and clonidine, were withdrawn for at least 2 weeks. Washout period for diuretics including spironolactone were 4 weeks. Non-dihydropyridine calcium channel blockers (slow released verapamil) and/or alpha-blocker (terazosin) are allowed for controlling blood pressure when needed. If the serum potassium value<3.6 mmol/L, an oral potassium supplement was prescribed. After keeping upright position for 2 hours, blood samples were drawn for PRA and PAC measurement between 9:00AM-10:00AM.

RESULTSARR was 100.00+/-48.65 (14.19-285.16) pg/ml vs ngxml-1xh-1 in patients with essential hypertension and 699.33+/-213.33 (185.8-2150) pg/ml vs ngxml-1xh-1 in patients with adenoma/hyperplasia. ARR value was greater than 240 in 42 out of 45 patients (93.3%) with adenoma/hyperplasia and was less than 240 in 59 out of 65 (90.7%) patients with essential hypertension. We used ARR 240 as the cut-off threshold for screening primary aldosteronism in another 178 hypertensive patients and ARR was greater than 240 in all 15 patients with confirmed primary aldosteronism.

CONCLUSIONIt is suitable to use upright ARR 240 as a cut-off threshold for screening primary aldosteronism in Chinese hypertensive patients.

Adult ; Aged ; Aldosterone ; blood ; China ; epidemiology ; Clinical Chemistry Tests ; statistics & numerical data ; Female ; Humans ; Hyperaldosteronism ; diagnosis ; epidemiology ; Hypertension ; complications ; epidemiology ; Male ; Mass Screening ; Middle Aged ; Potassium ; blood ; Reference Values ; Renin ; blood ; Renin-Angiotensin System

Design space approach was applied in this study to optimize the lime milk precipitation process of Lonicera Japonica (Jinyinhua) aqueous extract. The evaluation indices for this process were total organic acid purity and amounts of 6 organic acids obtained from per unit mass of medicinal materials. Four critical process parameters (CPPs) including drop speed of lime milk, pH value after adding lime milk, settling time and settling temperature were identified by using the weighted standardized partial regression coefficient method. Quantitative models between process evaluation indices and CPPs were established by a stepwise regression analysis. A design space was calculated by a Monte-Carlo simulation method, and then verified. The verification test results showed that the operation within the design space can guarantee the stability of the lime milk precipitation process. The recommended normal operation space is as follows： drop speed of lime milk of 1.00-1.25 mL•min⁻¹, pH value of 11.5-11.7, settling time of 1.0-1.2 h, and settling temperature of 10-20 ℃..

Quality by design principle was used as a guideline in this study to optimize ethanol reflux extraction of red ginseng. Firstly, hazard and operability analysis(HAZOP) was used as a risk assessment tool to evaluate the hazard degree of process parameters.Ethanol concentration, the ratio of alcohol and herbal material (A/M ratio), and extraction time were identified as the critical process parameters(CPPs) according to HAZOP method.Secondly, Box-Behnken experimental design was applied to establish theregression models between CPPs and the process indices. Finally, the design space was calculated. The recommended operation space of parametersis as follows：alcohol concentration of 90.3%-90.7%, A/M ratio of 2.5-3.1 mL•g ⁻¹ and extraction time of 124-130 min. The study shows that the design space approach combined with the risk assessment using HAZOP has the potential to reduce the risk of red ginseng extraction process, which might ultimately improve the process control..

Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy. In this work, recent research advances in QbD concept implementation methods in the secondary development of Chinese patent medicines were reviewed, and five promising fields of the implementation of QbD concept were pointed out, including the research and development of TCM new drugs and Chinese medicine granules for formulation, modeling of pharmaceutical processes, development of control strategy based on industrial big data, strengthening the research of process amplification rules, and the development of new pharmaceutical equipment..

Continuous pharmaceutical manufacturing is one of the development directions in international pharmaceutical technology. In this study, a continuous mixing technology of ethanol and concentrated extract in the ethanol precipitation of Salvia miltiorrhiza was realized by using a membrane dispersion method. The effects of ethanol flowrate, concentrated extract flowrate, and flowrate ratio on ethanol precipitation results were investigated. With the increase of the flowrates of ethanol and concentrated extract, retention rate of active phenolic acids components was increased, and the total solid removal rate was decreased. The purity of active components in supernatants was mainly affected by the ratio of ethanol flowrate and concentrated extract flowrate. The mixing efficiency of adding ethanol under continuous flow mixing mode in this study was comparable to that of industrial ethanol precipitation. Continuous adding ethanol by using a membrane dispersion mixer is a promising technology with many advantages such as easy enlargement, large production per unit volume, and easy control.