Preparation of Tamsulosin Hydrochloride-Loaded Mucoadhesive In Situ Gelling Polymeric Formulation for Nasal Delivery in Geriatrics.

This study aimed to prepare tamsulosin hydrochloride (HCl)-loaded in situ gelling formulation by using hydroxypropyl methylcellulose (HPMC), gellan gum, poloxamer 188, and benzalkonium chloride. Physicochemical evaluation of formulations included determination of pH, viscosity, gelation time, gel strength, drug content, and sterility. In silico study was performed to analyze interactions between polymers, drug, and mucin glycoprotein. In vitro degradation time, drug release, ex vivo mucoadhesion time, permeation, in vivo pharmacokinetics, and stability studies were performed to assess the formulation. Formulations were transparent and displayed acceptable physicochemical attributes. Tamsulosin HCl and polymers interacted via non-covalent interactions. HPMC formed hydrogen bonds, hydrophobic and van der Waals interactions with mucin protein while the drug formed hydrogen bonds only. Gel formulation degraded in simulated nasal fluid within 24 h. In situ gelling formulation showed 83.8 ± 1.7% drug release and remained adhered to the mucosa for 24.5 ± 1 h. A higher (~ 1.85 times) drug permeation was recorded through mucosa within 6 h by in situ gelling formulation when compared to control counterparts (aqueous solution of drug and in situ gelling formulation without poloxamer 188). Nasal administration of tamsulosin HCl by using in situ gelling formulation led to a ~ 3.3 and ~ 3.5 times, respectively, higher Cmax (maximum plasma concentration) and AUCtotal (total area under the curve) than the orally administered aqueous solution. Relative bioavailability of drug delivered by nasal in situ gelling formulation was 3.5 times the oral counterpart. These results indicated that the prepared in situ gelling formulation can act as a promising candidate for systemic administration of tamsulosin HCl.

Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol.

In this study, we developed a tamsulosin pellet-loaded orally disintegrating tablet (ODT) that is bioequivalent to commercially available products and has improved patient compliance using microcrystalline cellulose (MCC) and mannitol. Utilizing the fluid bed technique, the drug, sustained release (SR) layer, and enteric layer were sequentially prepared by coating MCC pellets with the drug, HPMC, Kollicoat, and a mixture of Eudragit L and Eudragit NE, respectively, resulting in the production of tamsulosin pellets. The tamsulosin pellet, composed of the MCC pellet, drug layer, SR layer, and enteric layer at a weight ratio of 20:0.8:4.95:6.41, was selected because its dissolution was equivalent to that of the commercial capsule. Tamsulosin pellet-loaded ODTs were prepared using tamsulosin pellets and various co-processed excipients. The tamsulosin pellet-loaded ODT composed of tamsulosin pellets, mannitol-MCC mixture, silicon dioxide, and magnesium stearate at a weight ratio of 32.16:161.84:4.0:2.0 gave the best protective effect on the coating process and a dissolution profile similar to that of the commercial capsule. Finally, no significant differences in beagle dogs were observed in pharmacokinetic parameters, suggesting that they were bioequivalent. In conclusion, tamsulosin pellet-loaded ODTs could be a potential alternative to commercial capsules, improving patient compliance.

Formulation and Evaluation of Eudragit® RL Polymeric Double Layer Films for Prolonged-Release Transdermal Delivery of Tamsulosin Hydrochloride.

Transdermal drug delivery systems (TDDSs) were developed for prolonged tamsulosin (TMS) delivery. Double layer (DL) TDDSs were prepared using Eudragit® RL by conventional film-forming. Ethylene-vinyl acetate was used as the backing layer, triethylcitrate as plasticizer, and Capmul® PG-8-70 NF and Captex 170 EP as penetration enhancers (PEs). An increase in either drug or PE concentration caused a significant increase in drug permeation flux. Modulation of drug permeation across Strat-M® membrane was examined using a single layer (SL) having the same thickness and drug content as the DLs, while the DLs were formulated to have variable drug spatial distribution across each layer (DL 4:6 and DL 6:4). SL/TDDS showed significantly higher daily drug permeation than DL/TDDSs for the first 4 days which could be related to the presence of high TMS concentration located on the upper surface of SL/TDDS as a result of solute migration of TMS during the drying process. However, this increase was followed by a progressive linear decrease after 5 days. Deflection points that were characterized by lower drug flux had been shown by SL/TDDS at more than one-point times. In contrast, DL 4:6 and DL 6:4 TDDSs demonstrated an ability to sustain TMS delivery for up to 2 weeks.

Green & Sensitive pH-dependent Spectrofluorimetric Assay of Tamsulosin Hydrochloride and Tadalafil in their New Combined Formulation for Benign Prostatic Hyperplasia: Application to Spiked Human Plasma.

Sensitive and green spectrofluorimetric methods were utilized for Tamsulosin Hydrochloride (TAM) and Tadalafil (TDL) assessment in bulk and their newly available combined mixture for benign prostatic hyperplasia and erectile dysfunction. The technique relies on measuring native fluorescence of TAM in 0.1 N HCl at 324 nm and TDL in 0.1 N NaOH at 348 nm due to their different fluorimetric behavior in acidic and basic media where TAM has no fluorescence in basic medium and vice versa. To achieve better regression, the spectra were derivatized allowing determination of TAM at 314 nm and TDL at 320 and 380 nm (peak to peak) by applying third and first derivative, respectively. In addition, pH-dependent "constant-wavelength synchronous" spectrofluorimetry was applied where TAM and TDL were determined at 218 nm in acidic medium and at 268 nm in basic medium, respectively. Finally, derivatizing the latter emission spectra allowed determination of TAM and TDL at 232 nm and at 262 and 278 nm (peak to peak), respectively. Acidic and basic emission spectra where scanned at λexc = 225 nm (for TAM assay) and at λexc = 247 nm (for TDL assay), respectively. Fluorescence-concentration plots were linear and the proposed methods were used for analysis of TAM and TDL combined laboratory prepared formulation. These procedures are green, sensitive and of low cost which make them suitable for quality control analysis of the two drugs. In addition, the high selectivity of the proposed methods was tested by successfully applying them for TAM and TDL assay in plasma samples.

The effectiveness of tamsulosin hydrochloride with terazosin combination therapy for chronic prostatitis Type-III b.

Objectives: To study the therapeutic effects of combined tamsulosin hydrochloride and terazosin treatment for patients with chronic prostatitis Type-III b. Methods: This study involved 180 patients with chronic prostatitis Type-III b treated between January 2018 and December 2020 conducted at Nanhua Hospital Affiliated to Nanhua University. Patients were randomly divided into two equal groups: one receiving oral terazosin hydrochloride tablets only (control group), and one orally receiving both tamsulosin hydrochloride sustained-release tablets and terazosin hydrochloride tablets (observation group). Outcome measurements included symptom scoring, inflammatory cytokine levels, as well as white blood cell and lecithin body counts in the prostatic fluid. Results: After 30 days of treatment, the observation group showed greater treatment effectiveness (86.67% vs. 73.33%, P<0.05). QLS, USS, PS, and NIH-CPSI symptom scores were lower in the observation group than the control group (P<0.05). No differences in adverse event distribution and incidence were noted. EPS IL-2 increased more in the observation group, while PGE-2, MIP-1α, and MIP-2 decreased more in the observation group. WBC levels decreased more in the observation group, while lecithin body levels increased more in the observation group. Conclusion: The combination of tamsulosin hydrochloride and terazosin for the treatment of patients with chronic prostatitis Type-III b has a significant effect. This approach reduced patient symptoms, lowered inflammatory biomarkers, and generally improved quality of life. This approach appears to have clinical value worthy of future investigation.

Potent Anti⁃bacteria Activity of Tamsulosin Hydrochloride and Ningmitai Capsule in Combination by Regulating the Gene Expression Related to β⁃Lactamase, Hemolysis, and Virulence / 中国生物化学与分子生物学报

Tamsulosin hydrochloride (TSH) is a selective α

Application of reusable flat-membrane in electro-membrane extraction for tamsulosin hydrochloride determination in cleaning validation samples of sterile production line equipment by RP-HPLC.

In order to ensure compliance with the current Good Manufacturing Practice (cGMP), cleaning process of pharmaceutical manufacturers should be validated. This study was aimed to utilize a reusable flat-membrane in the electromembrane extraction (EME) for isolation of tamsulosin hydrochloride (TMS) from rinse samples of sterile production of pharmaceutical line. Moreover, validation of mentioned method was done. The residual concentration of TMS was determined by RP-HPLC. Effective parameters such as pH, applying voltage and extraction time were optimized individually. Optimum conditions were found 12, 100 V and 10 min for pH, applying voltage and extraction time, respectively. Figures of merit were calculated under optimum conditions, therefore, linear range and limit of detection (LOD) were obtained 0.5-1000 ng mL-1 with a good coefficient of determination (R2=0.9901) and 0.05 ng mL-1, respectively. Last but not least, RSD of determination was found 0.67% which shows a satisfactory repeatability. According to the obtained results, proposed method is a precise, accurate, relatively fast and applicable route to determine TMS concentrations in rinse samples.

Prazosin but Not Tamsulosin Sensitises PC-3 and LNCaP Prostate Cancer Cells to Docetaxel.

BACKGROUND/AIMS: Docetaxel is currently the first-line chemotherapeutic agent available for the treatment of patients with advanced prostate cancer (PCa). While docetaxel has been shown to modestly improve survival times for patients; they also experience significant docetaxel-induced toxicities. If treatment failure occurs, there are currently limited alternatives that show survival benefits for patients and therefore there is an urgent need for adjunct therapies. Some quinazoline-based alpha1-adrenoceptor (ADR) antagonists have previously been shown to have cytotoxic actions in PCa cells, but there is no research into their effects on docetaxel-induced toxicity. Therefore, the aim of this study was to determine if the quinazoline ADR, prazosin influenced the sensitivity of PCa cells to docetaxel in vitro. We hypothesised that prazosin, but not tamsulosin, in combination with docetaxel would possess synergistic cytotoxic actions on PC-3 and LNCaP PCa cells. METHODS: PC-3 and -LNCaP cells were pre-treated (1 h) with prazosin (30 µmol/L) or tamsulosin (30 µmol/L), followed by docetaxel (12.5-100 µmol/L) for 24 h. Docetaxel-induced toxicity was measured in terms of changes in cell proliferation, autophagy, apoptosis and the production of reactive oxygen species (ROS). RESULTS: Prazosin sensitised both cell lines (PC-3 and LNCaP) to docetaxel-induced toxicity. This effect appears to be mediated by autophagy and may also involve apoptosis. These sensitising effects of prazosin appear to be largely independent of ROS production. In contrast, tamsulosin did not affect docetaxel-induced toxicity. CONCLUSION: We have shown for the first time that prazosin increases docetaxel-induced toxicity in PC-3 and LNCaP cells. Prazosin may therefore offer a viable treatment option in combination with docetaxel in metastatic PCa.

Relative Bioavailability of Fixed-Dose Combinations of Tamsulosin and Dutasteride: Results From 2 Randomized Trials in Healthy Male Volunteers.

The relative bioavailabilities of dutasteride/tamsulosin hydrochloride 0.5 mg/0.2 mg fixed-dose combination (FDC) capsules compared with coadministered reference products (1 dutasteride 0.5-mg capsule [Avodart® ] + 1 tamsulosin hydrochloride 0.2-mg orally disintegrating tablet [Harnal D® ]) were investigated in 2 clinical trials under fasted and fed conditions (ClinicalTrials.gov NCT02184585 and NCT02509104). Both trials were open-label, randomized, single-dose, crossover studies in healthy male adults aged 18-65 years. Trial 1 evaluated 2 formulations (FDC1 and FDC2), and trial 2 evaluated a third formulation (FDC3). The primary end points were dutasteride area under the concentration-time curve from time 0 to t (AUC(0-t) ) and peak plasma concentration (Cmax ) and tamsulosin AUC(0-∞) , AUC(0-t) , and Cmax . The formulations were considered to be bioequivalent if the 90%CIs for the geometric mean ratios for each end point were within the range of 0.80-1.25. For FDC1 in trial 1, bioequivalence criteria were not met for dutasteride Cmax or AUC in the fasted state or for tamsulosin Cmax in the fasted or fed states. For FDC2 in trial 1, all bioequivalence criteria were met except for tamsulosin Cmax in the fasted state. For FDC3 in trial 2, bioequivalence criteria were met for all dutasteride and tamsulosin end points in both the fed and fasted states. Safety profiles were similar for all FDC formulations and combination treatments.

Quantification of Tamsulosin Hydrochloride and Solifenacin Succinate by Discriminative Derivative Synchronous Emission Spectroscopy.

OBJECTIVES: The present study was undertaken with the objective to develop and validate a simple spectrofluorimetric method for the simultaneous quantification of tamsulosin hydrochloride and solifenacin succinate. MATERIALS AND METHODS: First-derivative synchronous spectrofluorimetry was attempted for the simultaneous quantification of the analytes. Tamsulosin hydrochloride was quantified at a wavelength of 322 nm (zero-crossing wavelength point of solifenacin succinate) and solifenacin succinate was measured at 570 nm (zero-crossing wavelength point of tamsulosin hydrochloride). RESULTS: Calibration plots were constructed over the concentration range of 2-10 µg/mL for tamsulosin hydrochloride and 30-150 µg/mL for solifenacin succinate. The method gave satisfactory results when it is validated for linearity, specificity, accuracy, precision, LOD and LOQ as per the ICH guidelines. The assay values in the commercial formulation were found to be in the percentage range of 95.0 for tamsulosin hydrochloride and 103.5 for solifenacin succinate by the proposed method. These results were well in agreement with their label claim. CONCLUSION: The proposed synchronous analytical method can be employed for routine quality control analysis of tamsulosin hydrochloride/solifenacin succinate in tablet dose forms.

[The effect of drug oil moxibustion for contents of Zinc and C-reactive protein in succus prostaticus of chronic nonbacterial prostatitis].

OBJECTIVE: To observe the clinical effects differences and partial mechanism for chronic nonbacterial prostatitis (CNP) among drug oil moxibustion, simple moxibustion, and conventional western medicine. METHODS: A total of 120 patients who met the criteria of inclusion were randomly assigned into a drug oil moxibustion group, a moxibustion group and a western medication group, 40 cases in each one. Moxibustion was used at Guanyuan (CV 4), Zhongji (CV 3), Qihai (CV 6) and bilateral Yinlingquan (SP 9), Sanyinjiao (SP 6), Shenshu (BL 23), Mingmen (GV 4), Pangguangshu (BL 28), Ciliao (BL 32), and Zhibian (BL 54), etc. The same moxibustion was used at the same acupoints in the drug oil moxibustion group after external application of medicated oil. Thirty min treatment was used once a day in alternated abdomen and back. In the western medication group, oral tamsulosin hydrochloride capsules were applied once a day, one capsule at a time. All the treatment was given for 30 days. Chronic prostatitis symptom index from National Institutes for Health (NIH-CPSI), the contents of Zinc (Zn) and C-reactive protein (CRP), as well as the number of white blood cells (WBC) and density of lecithin bodies were observed before and after treatment and 1 month after treatment. The effects were evaluated after treatment. RESULTS: After treatment, the total effective rate of the drug oil moxibustion group was 90.0% (36/40), which was significantly higher than 72.5% (29/40) of the moxibustion group and 62.5% (25/40) of the western medication group (both P<0.05). After treatment and at follow-up in the three groups, the NIH-CPSI scores were lower than those before treatment (all P<0.05), and those in the drug oil moxibustion group were lower than the results in the moxibustion group and the western medication group (all P<0.05). The contents of Zn in the three groups were higher than those before treatment (all P<0.05), with better results in the drug oil moxibustion group (all P<0.05), and higher Zn contents in the moxibustion group compared with those in the western medication group (both P<0.05). The CRP levels were lower than those before treatment (all P<0.05), and those in the drug oil moxibustion group were better than those in the moxibustion group and western medication group (all P<0.05). The CRP contents in the moxibustion group were lower than those in the western medication group (both P<0.05). The number of WBC were lower than those before treatment (all P<0.05), with better results in the drug oil moxibustion group (all P<0.05). The concentrations of lecithin were higher than those before treatment (all P<0.05), with better results in the drug oil moxibustion group (all P<0.05). CONCLUSIONS: The clinical effect of drug oil moxibustion is better than those of simple moxibustion and western medicine, which has advantages in improving clinical symptoms, Zn, the density of lecithin body and decreasing CRP content and the number of WBC.

[The study of renal safety in elderly patients with benign prostatic hyperplasia treated with α receptor blockers].

Objective: To investigate the renal safety in patients with benign prostatic hyperplasia treated with tamsulosin hydrochloride. Methods: A retrospective analysis of 10 cases of patients, who had renal dysfunction after treatment with long-term tamsulosin hydrochloride. Results: The average duration of oral medicine was 2 to 24 months with an average of 7.2 months. The serum creatinine after discontinuation of tamsulosin hydrochloride decreased from 132.5 µmol/L (100-208 µmol/L, normal 59-104 µmol/L) to 95.7 µmol/L (73-122 µmol/L, normal: 59-104 µmol/L) (F=10.385, P=0.000). Conclusion: Preliminary results show that taking tamsulosin hydrochloride might lead to renal damage in old patients with benign prostatic hyperplasia. Safety is the premise, and the right medicine should be chosen for different side effects in order to protect the safety of patient.

Superparamagnetic graphene oxide-based dispersive-solid phase extraction for preconcentration and determination of tamsulosin hydrochloride in human plasma by high performance liquid chromatography-ultraviolet detection.

In the present study, superparamagnetic graphene oxide-Fe3O4 nanocomposites were successfully prepared by a modified impregnation method (MGOmi) and their application as a sorbent in the magnetic-dispersive solid phase extraction (M-dSPE) mode to the preconcentration and determination of tamsulosin hydrochloride (TMS) in human plasma was investigated by coupling with high performance liquid chromatography-ultraviolet detection (HPLC-UV). The structure, morphology and magnetic properties of the prepared nanocomposites were characterized using X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FT-IR), scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDX), and vibrating sample magnetometry (VSM). Some factors affecting the extraction efficiency, including the pH value, amount of sorbent, extraction time, elution solvent and its volume, and desorption time were studied and optimized. Magnetic nanocomposites plasma extraction of TMS following HPLC analyses showed a linear calibration curve in the range of 0.5-50.0ngmL-1 with an acceptable correlation coefficient (R2=0.9988). The method was sensitive, with a low limit of detection (0.17ngmL-1) and quantification (0.48ngmL-1). Inter- and intra-day precision expressed as relative standard deviation (n=3) and the preconcentration factor, were found to be 5.6-7.2%, 2.9-4.2% and 10, respectively. Good recoveries (98.1-101.4%) with low relative standard deviations (4.2-5.0%) indicated that the matrices under consideration do not significantly affect the extraction process. Due to its high precision and accuracy, the developed method may be a HPLC-UV alternative with M-dSPE for bioequivalence analysis of TMS in human plasma.

Effect of tamsulosin hydrochloride combined with clear stasis and kidney decoction on chronic prostatitis and its influence on immune function and urine flow rate / 中国医师进修杂志

Objective To investigate the efficacy of tamsulosin hydrochloride combined with clear stasis and kidney decoction on chronic prostatitis and its influence on immune function and urine flow rate. Methods In this study, 115 patients with chronic prostatitis were selected and divided into treatment group (58 patients) and control group (57 patients) according to the random number table method.The control group used tamsulosin hydrochloride treatment, and the treatment group was treated with clear stasis and kidney decoction on the basis of the control group.The patients in two groups were treated continuously for 4 weeks. The clinical efficacy was evaluated and compared, the changes of immune function, free flow rate and maximum urinary flow rate were measured and compared between two groups.Results The total effective rate of the treatment group was significantly higher than that of the control group:94.83%(55/58)vs.78.95%(45/57)P<0.05.The levels of IgA and IgG before treatment in two groups had no significant differences(P>0.05).After treatment, the levels of IgA and IgG in two groups significantly decreased compared with those before treatment(P<0.05), and the levels of IgA and IgG in treatment group were significantly lower than those in control group(P<0.05).The levels of NIH-CPSI scores and WBC before treatment in two groups had no significant differences (P > 0.05). After treatment, The levels of NIH-CPSI scores and WBC significantly decreased compared with those before treatment(P<0.01), and the levels of NIH-CPSI scores and WBC in treatment group were significantly lower than those in control group (P < 0.01). After treatment lecithin (+- ++) and (+++- +++++) in treatment group was 3,55 cases, in control group was 12,45 cases, and there was significant difference (χ2= 6.392, P = 0.011). Before treatment, the levels of free urine flow rate, maximum urine flow rate, maximum urine flow rate time and residual urine volume in two groups had no significant differences(P>0.05). After treatment, the levels of free urine flow rate and maximum urine flow rate in two groups significantly increased, the levels of maximum urine flow rate time and residual urine volume in two groups significantly decreased, and there were significantly differences compared those before treatment (P < 0.05).The levels of free urine flow rate, maximum urine flow rate, maximum urine flow rate time and residual urine volume between two groups had significant differences after treatment(P<0.01).The adverse reaction rate in control group and treatment group was 3.51%(2/57),6.90%(4/58), and there was no significant difference(χ2=0.414,P=0.667).Conclusions Tamsulosin hydrochloride combined with clear stasis and kidney decoction in patients with chronic prostatitis can significantly relieve the clinical symptoms and improve the immune function of the local prostate, and the effect is exact.

Clinical study on treatment of chronic prostatitis complicated with Prostate Glioclones with urinary stone pill combined with Tylenol Hydrochloride Sustained Release Capsule / 中国生化药物杂志

Objective To study the effect of urine stone pills combined with tamsulosin hydrochloride sustained-release capsules in the treatment of chronic prostatitis with prostatic calculi. Methods 76 patients with chronic prostatitis with prostate stones who had been hospitalized were treated as 76 patients in this study. A total of 38 patients in a single group were treated with tylosine hydrochloride sustained-release capsules. 38 patients in the combined group were treated with Urethomide Pill on the basis of a single group of patients. The chronic prostatitis symptom index (NIH-CPSI) Clinical efficacy, white blood cell levels in prostatic fluid and the incidence of adverse reactions. Results The total effective rate was 94.74 % in the combined group, which was significantly lower than that in the single group (76.32 %)(P<0.05); the NIH-CPSI and prostatic fluid in the combined group were significantly lower than those in the single group(P<0.05), the incidence of adverse reactions in a single group was 7.89 %, and there was no significant difference between the combined group(5.26 %). Conclusion The treatment of chronic prostatitis with prostatic calculi is significant and feasible.

Clinical study on treatment of chronic prostatitis complicated with Prostate Glioclones with urinary stone pill combined with Tylenol Hydrochloride Sustained Release Capsule / 中国生化药物杂志

Objective To study the effect of urine stone pills combined with tamsulosin hydrochloride sustained-release capsules in the treatment of chronic prostatitis with prostatic calculi. Methods 76 patients with chronic prostatitis with prostate stones who had been hospitalized were treated as 76 patients in this study. A total of 38 patients in a single group were treated with tylosine hydrochloride sustained-release capsules. 38 patients in the combined group were treated with Urethomide Pill on the basis of a single group of patients. The chronic prostatitis symptom index (NIH-CPSI) Clinical efficacy, white blood cell levels in prostatic fluid and the incidence of adverse reactions. Results The total effective rate was 94.74 % in the combined group, which was significantly lower than that in the single group (76.32 %)(P<0.05); the NIH-CPSI and prostatic fluid in the combined group were significantly lower than those in the single group(P<0.05), the incidence of adverse reactions in a single group was 7.89 %, and there was no significant difference between the combined group(5.26 %). Conclusion The treatment of chronic prostatitis with prostatic calculi is significant and feasible.

Efficacy Observation of Qianliexin Combined with Tamsulosin Hydrochloride and Finasteride in the Treatment of Elderly Benign Prostatic Hyperplasia / 中国药房

OBJECTIVE:To observe the clinical efficacy of qianliexin combined with tamsulosin hydrochloride and finasteride in the treatment of elderly benign prostatic hyperplasia.METHODS:Ninety-four patients diagnosed as benign prostatic hyperplasia in our hospital during May.2012-Oct.2014 were selected and divided into observation group (48 cases) and control group (46 cases) according to even and odd admission number.Both groups received Finasteride tablet 5 mg,po,qd.Basedon this,control group was additionally given Tamsulosin hydrochloride sustained-release capsules 0.2 mg,po,qd;observation group was additionally given Qianliexin capsules 2.5 g,po,tid,on the basis of control group.Clinical efficacies of 2 groups were observed as well as IPSS,BS,IIEF-5 score,ultrasonic measurement indexes and TCM syndrome score before and after treatment.RESULTS:Clinical total response rate of observation group was 93.75％,which was significantly higher than 76.09％ of control group,with statistical significance (P＜0.05).Before treatment,there was no statistical significance in IPSS,BS,IIEF-5 score,ultrasonic measurement indexes and TCM syndrome score between 2 groups (P＞0.05).After treatment,IPSS and BS score,prostate volume (PV),residual urine(RU),each item score and total score of TCM syndrome were significantly decreased in 2 groups,while IIEF-5 score and Qmax were increased significantly;the observation group was significantly better than the control group,with statistical significance (P＜0.05).CONCLUSIONS:Qianliexin combined with tamsulosin hydrochloride and finasteride shows significant therapeutic effi cacy for elderly benign prostatic hyperplasia,and is helpful to improve prostate symptoms and TCM syndromes,reduce PV and RU,and improve sexual function.

Effect of Paishitang Combined with Tamsulosin Hydrochloride on Upper Urinary Calculi after Extracorporeal Shock Wave Lithotripsy / 现代生物医学进展

Objective:To explore the clinical effect ofpaishitang combined with tamsulosin hydrochloride on the patient with up per urinary calculi after extracorporeal shock wave lithotripsy (ESWL).Methods:120 cases with upper urinary calculi in our hospital from January 2015 to September 2016 were selected and divided into two groups according to the random number table,60 cases in each group.ESWL was given to both groups of patients and provided with tamsulosin hydrochloride postoperation,then paishitang were additionally given to the patients in the observation group.The clinical effect and changes of serum creatinine (Scr),neutrophil gelatinase as sociated lipocalin (NGAL),cystatin C (Cys-C) and glomerular filtration rate (GFR) levels before and after treatment were compared between two groups.Results:The total effective rate of observation group was 96.67％,which was 86.67％ in the control group,no signifi cant difference was found in the total effective rate between the two groups(P＜0.05).The stone discharge rate was 95.00％ in the observation group,which was significantly higher than that of the control group (P＜0.05);the incidence rate of renal colic was 6.67％,which was significantly lower than that of the control group(P＜0.05),the stone discharge time and the duration of hematuria were significantly shorter than those in the control group (P＜0.01).There was no significant difference in the recurrence rate between the two groups within one year (P＞0.05).The serum NGAL and Cys-C levels of both groups were gradually increased while the GFR levels were gradually decreased on the 1st,2nd day postoperation,but all the index mentioned above gradually recovered on the 3rd day postoperation.The levels of NGAL and Cys-C in the observation group were significantly lower than those in the control group on the 1st,3rd day postoperation while the GFR was significantly higher in the observation group than those of control group on the 1st,3rd day postoperation(P＜0.01).No significant difference was found in the Scr at different time points postoperation between two groups(P＞0.05).Conclusion:Paishitang combined with tamsulosin hydrochloride had significant clinical effect on thpatient with upper urinary calculus after ESWL and could effectively improve the renal injury induced by ESWL.

The effect of drug oil moxibustion for contents of Zinc and C-reactive protein in succus prostaticus of chronic nonbacterial prostatitis / 中国针灸

<p><b>OBJECTIVE</b>To observe the clinical effects differences and partial mechanism for chronic nonbacterial prostatitis (CNP) among drug oil moxibustion, simple moxibustion, and conventional western medicine.</p><p><b>METHODS</b>A total of 120 patients who met the criteria of inclusion were randomly assigned into a drug oil moxibustion group, a moxibustion group and a western medication group, 40 cases in each one. Moxibustion was used at Guanyuan (CV 4), Zhongji (CV 3), Qihai (CV 6) and bilateral Yinlingquan (SP 9), Sanyinjiao (SP 6), Shenshu (BL 23), Mingmen (GV 4), Pangguangshu (BL 28), Ciliao (BL 32), and Zhibian (BL 54), etc. The same moxibustion was used at the same acupoints in the drug oil moxibustion group after external application of medicated oil. Thirty min treatment was used once a day in alternated abdomen and back. In the western medication group, oral tamsulosin hydrochloride capsules were applied once a day, one capsule at a time. All the treatment was given for 30 days. Chronic prostatitis symptom index from National Institutes for Health (NIH-CPSI), the contents of Zinc (Zn) and C-reactive protein (CRP), as well as the number of white blood cells (WBC) and density of lecithin bodies were observed before and after treatment and 1 month after treatment. The effects were evaluated after treatment.</p><p><b>RESULTS</b>After treatment, the total effective rate of the drug oil moxibustion group was 90.0% (36/40), which was significantly higher than 72.5% (29/40) of the moxibustion group and 62.5% (25/40) of the western medication group (both<0.05). After treatment and at follow-up in the three groups, the NIH-CPSI scores were lower than those before treatment (all<0.05), and those in the drug oil moxibustion group were lower than the results in the moxibustion group and the western medication group (all<0.05). The contents of Zn in the three groups were higher than those before treatment (all<0.05), with better results in the drug oil moxibustion group (all<0.05), and higher Zn contents in the moxibustion group compared with those in the western medication group (both<0.05). The CRP levels were lower than those before treatment (all<0.05), and those in the drug oil moxibustion group were better than those in the moxibustion group and western medication group (all<0.05). The CRP contents in the moxibustion group were lower than those in the western medication group (both<0.05). The number of WBC were lower than those before treatment (all<0.05), with better results in the drug oil moxibustion group (all<0.05). The concentrations of lecithin were higher than those before treatment (all<0.05), with better results in the drug oil moxibustion group (all<0.05).</p><p><b>CONCLUSIONS</b>The clinical effect of drug oil moxibustion is better than those of simple moxibustion and western medicine, which has advantages in improving clinical symptoms, Zn, the density of lecithin body and decreasing CRP content and the number of WBC.</p>

Preparation of tamsulosin hydrochloride sustained-release pellets / 第二军医大学学报

Objective To prepare tamsulosin hydrochloride sustained-release pellet by coating with acrylic copolymers. Methods EUDRAGIT® NE 30 D was used as the main sustained-release material, EUDRAGIT® L 30 D-55 and Methocel® E3 were used as release adjust agent; a one layer sustained-release coating was done for tamsulosin hydrochloride-loaded pellet in bottom spray fluid bed. A three factor, three-level Box-Behnken design was used to optimize the percentages of EUDRAGIT® L 30 D-55 and Methocel® E3 in the total dry polymers and the weight gain of total dry polymers as the three nonlinear factors, which mainly influenced drug release of the pellets in the formula of sustained-release coating layer. In-vitro cumulative drug release after 2 h, 3 h and 5 h was tested and the following target range:2 h 12%-39%, 3 h 44%-70% and 5 h>70% were set for optimization. Results The formulation and process of one layer sustained-release coating, which was synergistically controlled by the three materials based on acrylic copolymers, was determined after optimization:the total dry polymers were applied with a weight gain of 12% on drug pellets, with EUDRAGIT® L 30 D-55 dry polymers and Methocel® E3 being 7% and 2% of the total dry polymers, respectively. The sustained-release pellets coated with the optimized formulation provided a release profile that was close to the predicted value and similar to that of the commercial product Harnal® capsule pellets by f2 similarity factor comparison (f2 values of three batches were 71,73 and 80). Conclusion The established formulation and process is a simple and reproducible method to prepare tamsulosin hydrochloride sustained-release pellets with good stability.