报告从医药行业事件分析、竞争环境、竞争对手、行业数据等几个方面进行了分析评论。

报告从医药行业事件分析、竞争环境、竞争对手、行业数据等几个方面进行了分析评论。

报告从政策环境、市场行情、厂商动态、科技研发、国际资讯、行业数据、分析评论等几个方面对医药行业进行了分析评论。

报告从产业动态、产业分析、技术趋势、企业跟踪、地方动向等几个方面对生物科技产业进行了分析评论。

An ostomy procedure involves the surgical creation of an opening or stoma in the human body to excrete waste products such as stools, mucus, and urine. The surgery can be a temporary or permanent procedure depending on the type of condition and the needs of the patient. The surgery can be classified into colostomy, ileostomy, and urostomy and is helpful in the treatment of intestinal and bladder diseases. Ostomy products include ostomy bags or pouches and ostomy care accessories. Ostomy bags are placed outside the patient's body to collect waste. Whereas, ostomy care accessories enhance the performance and comfort of ostomy bags to manage the needs of ostomates. These accessories help to provide skin care for the peristomal region, prevent leakage of the ostomy bag contents, and deodorize the contents.

LSDs are a group of progressive, autosomal recessive, and hereditary disorders characterized by the accumulation of specific substrates and variable age of onset and clinical symptoms. Pompe disease, a type of LSD, is caused by mutations in the GAA gene. These mutations inhibit the mechanism of action of GAA, an enzyme responsible for catabolizing glycogen, resulting in accumulation of glycogen to toxic levels in the lysosomes of the cells. The buildup of glycogen in certain organs and tissues, especially in the muscles, hinders the normal functions of the organs. Pompe disease can be further classified as infantile-onset and adult-onset Pompe disease. As the disease is an autosomal recessive hereditary disorder, both parents are carriers and pass one copy of the mutated gene to their offspring. The disease affects both men and women across all ethnicities and races and has a varied age of onset of symptoms. To date, researchers have identified more than 300 genetic mutation types that lead to disease manifestation. Though there is no known cure for the disease, diet therapy and enzyme replacement therapy have been effective in reducing its clinical manifestations.

A male external catheter, also called a condom catheter, drains urine without insertion of the catheter into the urethra. It is a flexible sheath placed over the penis and connected by a long tube attached to a urinary drainage bag. The sheath is usually made from latex rubber, vinyl, or silicone. It is affixed to the penis using either a double-sided adhesive strap or a latex or foam strap. Male external catheters are convenient and simple to use for short periods of time. These catheters need to be changed every 24 to 48 hours.

Urinary incontinence slings are flexible surgical mesh systems placed under the urethra or the bladder neck for support and to minimize incontinence efficiently. The procedure uses strips of tissues or a synthetic mesh to create a hammock-like fixture that wraps around the bladder neck. Urinary incontinence slings are also called urethral support slings. Urinary slings are of two major types: TOT and TVT.

目的：建立大鼠血浆中积雪草酸(asiatic acid，AA)的柱前衍生化HPLC，探讨AA在大鼠体内的药动学。方法：SD大鼠，♂，尾静脉注射AA(10mg?kg-1)，于给药后不同时间采取血浆，经DIKMA Proelut PLS柱固相萃取，柱前衍生化HPLC测定血浆中AA浓度(以甘草次酸为内标)，药物统计软件(PKS 1.0)拟合统计药动学参数。结果：血药浓度在0.1~20μg?mL-1内线性良好(r=0.9996)，平均提取回收率为71.1~79.9%，日内、日间精密度RSD均<13%，样品在?20℃放置，经2次冻融循环后基本稳定。AA在大鼠体内药-时曲线符合一室开放模型，主要药动学参数为：tmax=2.0min，Cmax=14.7μg?mL-1，t1/2=35.1min，AUC0-t=217.0μg?min?mL-1，AUC0-∞=234.3μg?min?mL-1。结论：AA在大鼠体内消除迅速，所建立的提取及柱前衍生化HPLC适用于体内AA的测定。

目的：建立一种衍生化LC-MS检测人血浆中消旋卡多曲活性代谢物thiorphan(TP)浓度，同时评价消旋卡多曲2种规格散剂(10 mg?袋-1和30 mg?袋-1)和国产颗粒剂在健康人体内的药动学及生物等效性。方法：采用3制剂3周期二重3×3拉丁方设计，18名健康男性志愿者交叉单剂量口服受试制剂2种规格消旋卡多曲散(10 mg?袋-1和30 mg?袋-1)和参比制剂消旋卡多曲颗粒剂各300 mg后，采用衍生化LC-MS测定不同时间血浆中活性代谢物TP浓度，用DAS药动学程序进行药动学参数的计算及生物等效性评价。血浆样品中加入p-BPB衍生化试剂，得到稳定的TP衍生化产物，经乙酸乙酯萃取后，选替米沙坦作内标。色谱柱为Zorbax SB-C18(150 mm×2.1 mm，5 μm)；流动相为5 mmol?L-1甲酸铵(甲酸调节pH至3.0)-乙腈(45︰55)；流速为0.2 mL?min-1；采用ESI+SRM方式监测；TP衍生化产物m/z 452.10[M+H]+，内标替米沙坦m/z 515.30[M+H]+。结果：TP线性范围为6.28~1 256 ng?mL-1，最低检测浓度为6.28 ng?mL-1，提取回收率在77.5%~80.4%，日内、日间精密度RSD<15%。受试制剂消旋卡多曲散(10 mg?袋-1)，消旋卡多曲散(30 mg?袋-1)和参比制剂消旋卡多曲颗粒的主要药动学参数：Tmax分别为(1.8±1.2)，(1.9±1.3)和(0.7±0.2)h，t1/2分别为(1.4±0.4)，(1.2±0.7)和(1.1±0.8)h，Cmax分别为(802.0±356.5)，(804.2±459.8)和(845.6±285.8)ng?mL-1，AUC0-8分别为(1 617.0±532.6)，(1 628.9±672.1)和(1 621.0±532.2)ng?h?mL-1，AUC0-∞分别为(1690.8±567.2)，(1673.8±681.7)和(1 649.4±561.4)ng?h?mL-1。2种受试制剂的相对生物利用度分别为99.8%和100.5%。结论：本方法灵敏，有效，可准确检测人体血浆中TP的浓度。2种受试制剂和参比制剂具有生物等效性。

目的：对4个厂家生产的盐酸倍他司汀片的溶出度进行考察比较，并探讨各厂家生产的盐酸倍他司汀片的质量差异。方法：采用小杯法，以盐酸溶液(9→1 000)250 mL为溶出介质，分别考察了50 r?min-1和75 r?min-1，用吸收系数法测定不同时间点的溶出量，对不同厂家生产的盐酸倍他司汀片的溶出速率曲线进行分析和比较。结果：各厂家产品溶出行为差别较大，产品质量存在差异。结论：不同厂家的盐酸倍他司汀片溶出度存在显著差异，有必要建立盐酸倍他司汀片溶出度检查方法，并对市售产品进行溶出度检查，从而控制药品质量，保证临床用药的有效性。

目的：建立HPLC测定枳术宽中胶囊中4种有效成分的测定方法。方法：采用高效液相色谱仪，色谱柱为C18柱(250 mm×4.6 mm，5 μm)，流速：1 mL?min-1，柱温：25 ℃，应用梯度洗脱、双波长检测等方法，对该制剂的4种有效成分(白术内酯Ⅰ、橙皮苷、柴胡皂苷a、柴胡皂苷d)进行定量分析。结果：白术内酯Ⅰ、橙皮苷、柴胡皂苷a和柴胡皂苷d的浓度分别在33.75~540 μg?mL-1(r=0.999 7)，194.5~311.2 μg?mL-1(r=0.999 5)，131.68~2 106.84 μg?mL-1(r=0.999 7)和17.08~273.32 μg?mL-1(r=0.999 8)内与峰面积呈良好的线性关系，平均回收率分别为99.58%，99.41%，99.77%，99.86%。结论：本方法操作简便，结果准确，重现性好，可用于枳术宽中胶囊的质量控制。