中文药品名: 人胰泌素合成脂
[通用名称]human secretin for injection,注射用人胰泌素
[商品名]ChiRhoStim
[化学结构]其氨基酸排列顺序为:H is-Ser-Asp-G ly-Thr-Phe-Thr-Ser-G lu-Leu-Ser-Arg-Leu-Arg-G lu-G ly-A la-Arg-Leu-G ln-Arg-Leu-Leu-G ln-G ly-Leu-Val-NH2相对分子质量:3039.44,分子式:C130H220N44O39
[药理作用]本品最主要的药理作用是增加胰液的分泌体积和其中碳酸氢盐的含量。在猫体上进行合成人胰泌素(sHS)、合成猪胰泌素(sPS)和猪胰泌素生物衍生物(bPS)的生物等效性研究,证实sHS和sPS在刺激胰外分泌胰液和碳酸氢盐上有相同的药理活性。sHS和sPS的活性0.2μg与bPS 1CU相当,即生物活性约为5.0 CU·μg-1。
[作用机制]胰泌素是十二指肠上端黏膜接触胃酸、脂肪酸或氨基酸后正常分泌的一种激素,由肠黏膜的肠色素细胞分泌,其受体已证实存在于胰脏、胃、肝、结肠和其他组织。
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分类名称
一级分类：其他用药 二级分类：诊断用药 三级分类：器官功能检查诊断剂
药品英文名
Secretin
药品别名
肠促胰液素、促胰液素、肠促胰液肽、分泌素、SecreFlo．、SEC
药物剂型
注射剂：每支含胰泌素16mg，L-半胱氨酸盐酸盐15mg。
药理作用
本品为含27个氨基酸的多肽类激素，与天然猪胰泌素具有相同的氨基酸序列。本品的主要作用是增加胰液的分泌和胰液中碳酸氢盐的含量。本品的活性标准单位以临床单位(clinicalunits，CU)表示，本品的效能相当于5000CU/mg的肽，等同于3000CU/mg的生物合成猪胰泌素。本品为纯肽类制剂，其含量用mg表示，胰泌素mg与生物活性之间的换算关系为：0.2mg＝1CU。
药动学
12名健康受试者静注本品0.4mg/kg后，大多数志愿者的血浆胰泌素浓度在60～90min内降至正常基线水平，血浆清除速率为(487±136)ml/min，表观分布容积为2L。
适应证
本品主要用于胰泌素刺激试验。
1.刺激胰腺分泌，包括碳酸氢盐的分泌，用来帮助诊断胰腺分泌功能障碍。
2.刺激胃泌素分泌，以诊断胃泌素瘤。刺激胰腺分泌，以在内窥镜逆行性胆管造影术(endoscopic retrograde cholangio pancreatography，ERCP)检查中区别十二指肠乳头胆道口壶腹及副壶腹。
禁忌证
1．急性胰腺炎患者禁用，直到急性发作期结束。
2．妊娠毒性分级为C级，动物试验未发现生殖毒性，尚不知孕妇用药是否影响胎儿或生殖能力，故本品不宜给孕妇使用，除非必需。
3．儿童用药的安全性和疗效尚不清楚，不推荐儿童使用。
注意事项
1．尚不知本品是否经人乳汁分泌，哺乳期妇女慎用。
2．迷走神经切断术患者、正在使用抗胆碱药的患者、炎性肠病患者可对本品的刺激呈低反应性，但该反应并不代表有胰脏疾病。
3．对胰泌素的刺激产生超过正常体积的胰液分泌，有可能掩盖并发的胰脏病，这种情况偶尔会在酒精性肝病或其他肝病患者身上发生。
4．临床研究显示，老年人与成年人使用相同剂量，其安全性、药理作用、诊断效果无差别，但不能排除个别患者敏感性增加。
5．本品溶解后立即注射，剩余的溶解液弃掉。
6．－20℃冷冻保存。
不良反应
偶见轻度不良反应。尽管在临床观察中未发现皮肤试验过敏或用药后过敏，但仍有引起过敏反应的可能，故用药前应先做皮试，皮试剂量为0.2mg(0.1ml)，皮试后1min无过敏反应症状方可用药，尤其有特异性变态反应或哮喘病史的患者，对严重过敏反应应立即采取适当解救措施。尚无长期动物试验研究本品的致癌作用、致畸形作用和致突变作用，小鼠和兔给药20mg/kg无致死。
用法用量
1．胰泌素刺激试验以辅助诊断胰腺分泌功能障碍：
患者禁食12～15h，在透视控制下，将不透过射线的双腔管的近侧管开口经口放入胃窦，远侧管开口置于法特乳头外，双管间断给予20～40mmHg负压，当十二指肠内容物pH＞6.0时收集十二指肠内基础样品10min。静注本品0.2mg(1ml)试验过敏反应，1min后如无过敏反应，1min内静注本品0.2mg/kg，收集十二指肠液共60ml，每15min分段收集共收集4部分，每次收集完后注射空气清洁十二指肠肠道。将每份液体冷却并对其体积及碳酸氢盐浓度进行分析，如果任何一个样品的碳酸氢盐浓度＜80mEq/L，均说明胰腺分泌功能与慢性胰腺炎密切相关。
2．刺激胃泌素分泌以诊断胃泌素瘤：患者至少禁食12h，抽取2份血浆样品测定血浆胃泌素浓度作为基础水平浓度，然后静注本品0.2mg(0.1ml)皮试，如未发生过敏，则1min内静注0.4mg/kg，分别于给药后1min、2min、5min、10min、30min取血浆样品测定胃泌素浓度，若任何一个给药后血浆中的胃泌素浓度比基础水平浓度增加110pg/ml，则胃泌素瘤可能性很大。
3．刺激胰腺分泌以在内窥镜逆行插管中区别法特壶腹和副乳头：胰腺分裂患者区别法特壶腹和副乳头时，1min内静注本品0.2mg/kg，看是否有胰液分泌物从乳头流出，有利于区分及套管插入术。将本品16mg溶于8ml生理盐水中，浓度为2mg/ml，强烈振摇使溶解，供注射用。
药物相应作用
合用抗胆碱药可使患者敏感性增强产生假阳性结果。
Indications
Stimulation of pancreatic secretions, including bicarbonate to aid in the diagnosis of exocrine pancreas dysfunction
Stimulation of gastrin secretion to aid in diagnosis of gastrinoma
Stimulation of pancreatic secretions to facilitate the identification of the ampulla of vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
Package Insert
ChiRhoStim�
Human Secretin for Injection
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ChiRhoStim� safely and effectively. See full prescribing information for ChiRhoStim�.
ChiRhoStim� (Human Secretin) Injection, lyophilized powder for intravenous use, 16 mcg and 40 mcg vials
Initial U.S. Approval: 2004
Human secretin is a gastrointestinal peptide hormone produced by cells in the duodenum in response to acidification. ChiRhoStim® (human secretin as the acetate) is a purified synthetic peptide with an amino acid sequence identical to the naturally occurring hormone. Synthetic human secretin is chemically defined as follows:
Structural Formula:
His-Ser-Asp-Gly-Thr-Phe-Thr-Ser-Glu-Leu-Ser-Arg-Leu-Arg-Glu-Gly-Ala-Arg-Leu-Gln-Arg-Leu-Leu-Gln-Gly-Leu-Val-NH2
ChiRhoStim® (human secretin) is available in two strengths:
•As a 10 ml vial which contains 16 mcg of purified synthetic human secretin, 1.5 mg of L-cysteine hydrochloride, 20 mg of mannitol, and 9 mg of sodium chloride. When reconstituted in 8 mL of Sodium Chloride Injection USP, each mL of solution contains 2 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.
•As a 10 ml vial which contains 40 mcg of purified synthetic human secretin, 3.75 mg of L-cysteine hydrochloride, 50 mg of mannitol, and 22.5 mg of sodium chloride per vial. When reconstituted in 10 mL of Sodium Chloride Injection USP, each mL of solution contains 4 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.
INDICATIONS
ChiRhoStim® (human secretin) is indicated for:
Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction,
Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and
Facilitation of the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
ChiRhoStim® (human secretin) 16 mcg vial:
Dissolve the contents of the ChiRhoStim® (human secretin) 16 mcg vial in 8 mL of Sodium Chloride Injection USP, to yield a concentration of 2 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution and discard any unused portion.
ChiRhoStim® (human secretin) 40 mcg vial:
Dissolve the contents of the ChiRhoStim® (human secretin) 40 mcg vial in 10 mL of Sodium Chloride Injection USP, to yield a concentration of 4 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution and discard any unused portion.
For both strengths, the reconstituted drug product should be inspected visually prior to administration. If particulate matter or discoloration is seen, the product should be discarded.
Dosage forms and strengths
ChiRhoStim® (human secretin) is available in two strengths:
As a lyophilized sterile powder in 10 mL vials containing 16 mcg of human secretin.
As a lyophilized sterile powder in 10 mL vials containing 40 mcg of human secretin.
Supplied
ChiRhoStim® (human secretin) is supplied in two strengths:
As a lyophilized sterile powder in vials containing 16 mcg of human secretin.
As a lyophilized sterile powder in vials containing 40 mcg of human secretin.
Storage
The unreconstituted product should be stored at -20°C (freezer). Expiration date is marked on the label. Protect from light.
SIDE EFFECTS
Mild to moderate adverse reactions have been noted for synthetic human secretin in clinical studies in 533 patients and 51 healthy volunteers. Two severe adverse reactions, nausea and abdominal pain, occurred in one patient. Table 1 details the type and number of patients with adverse reactions.
DRUG INTERACTIONS
The concomitant use of anticholinergic agents may make patients hyporesponsive to secretin stimulation and may produce a false result. Any results of secretin stimulation tests in these patients should thus be interpreted with caution.
WARNINGS
Included as part of the PRECAUTIONS section.
CONTRAINDICATIONS
Patients suffering from acute pancreatitis should not receive ChiRhoStim® (human secretin) until the acute episode has subsided.
附件:
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产地国家: 美国
原产地英文商品名:
CHIRHOSTIM 16MCG/VIAL 12VIALS/BOX
原产地英文药品名:
SECRETIN SYNTHETIC HUMAN
原产地英文化合物名称:
H is-Ser-Asp-G ly-Thr-Phe-Thr-Ser-G lu-Leu-Ser-Arg-Leu-Arg-G lu-G ly-A la-Arg-Leu-G ln-Arg-Leu-Leu-G ln-G ly-Leu-Val-NH2
中文参考商品译名:
CHIRHOSTIM 16微克/瓶 12瓶/盒
中文参考药品译名:
人胰泌素合成脂
生产厂家中文参考译名:
CHIRHOCLIN
生产厂家英文名:
CHIRHOCLIN
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产地国家: 美国
原产地英文商品名:
CHIRHOSTIM 16MCG/VIAL
原产地英文药品名:
SECRETIN SYNTHETIC HUMAN
原产地英文化合物名称:
H is-Ser-Asp-G ly-Thr-Phe-Thr-Ser-G lu-Leu-Ser-Arg-Leu-Arg-G lu-G ly-A la-Arg-Leu-G ln-Arg-Leu-Leu-G ln-G ly-Leu-Val-NH2
中文参考商品译名:
CHIRHOSTIM 16微克/瓶
中文参考药品译名:
人胰泌素合成脂
生产厂家中文参考译名:
CHIRHOCLIN
生产厂家英文名:
CHIRHOCLIN