|
英文药名：KALIAID PLUS（Calcium Polystyrene Sulfonate）
中文药名：聚苯乙烯磺酸钙散 96.7%
生产厂家：小野药品
カリエードプラス散（分包）９６．７％
治疗类别名称
高钾血症改善剂
商標名
KALIAID PLUS
一般名
ポリスチレンスルホン酸カルシウム
（Calcium Polystyrene Sulfonate）
構造式
该产品具有不规则冗杂一个复杂的三维结构，该结构是部分地如下。
性状
在精细黄白色至淡黄色粉末，无臭，味。
水，乙醇（95）或在乙醚中几乎不溶
1.由于本剂是一种口服，唯一代理，它不灌肠。
2.不兼容
（1）应避免与钙盐反应的物质的制剂。
（2）药物制剂以接收吸收抑制剂（例如，四环素）由钙应当避免。
3.稳定性试验
使用效果的最终包装产品（40℃，相对湿度75％，6个月）加速测试中，卡利援助塑料溶胶（袋）96.7％，据推测在市场流通的正常过程中稳定的三年大变样。
药效药理
1.钾交换容量
钙聚苯乙烯磺酸包括7.0至9.0％的钙。在体外试验中1G，取代的53〜71mg（1.36〜1.82mEq/g）的钾。
2. 作用机序
这种药物不会被消化吸收，肠道，尤其是在较低的结肠的附近，以释放它们的钙离子中，通过吸附钾离子，以除去钾离子在体内的肠道中的粪便中排出。
3.生物等效性试验
(1) 钾交换容量比较试验
这种药物的标准制剂（粉末）的钾交换容量的结果进行了测定，在两种药物的钾交换容量显著差异没有观察到，这两种药物的生物等效性已被证实。
(2) 药效学试验同时使用肾分离的鼠
这种药物1.5,3,6g结果，在这两个肾脏的标准制剂（粉末）分离的大鼠/kg /天（钙在聚苯乙烯磺酸而言的量）口服给药，这两种药物是生命延长在两个肾脏离体大鼠作用和血清钾浓度具有增加的抑制效果，其效力是相当，观察到两种药物的生物等效性。
适应病症
高钾血症急性和慢性肾功能衰竭
用法与用量
成人；每日服15.51天-31.02克三次，分三次口服（3-6包），单剂量与水30-50毫升口服给药。该剂量可根据症状来调节。
包装规格
散（分包）96.7%
5.17克×70包，5.17克×140包
製造商
小野薬品工業株式会社
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2190016B1035_1_07/
Caliado Plus scattered (sachet) 96.7%
Name of drug classification
Hyperkalemia remedy
Sales name
Caliado Plus scattered (sachet) 96.7%
Common name
Calcium polystyrene sulfonate
(Calcium Polystyrene Sulfonate)
Property
It is a slight yellowish to pale yellow powder with no odor and taste.
It is scarcely soluble in water, ethanol (95) or diethyl ether.
composition
Sales name
Caliado Plus scattered (sachet) 96.7%
composition
1 pack (5.17 g)
Contains 5 g of Calcium polystyrene sulfonate daily station.
Additive
Aspartame(L-phenylalanine compound), containing citric acid hydrate.
Contraindications
Patient with bowel obstruction[May cause intestinal perforation]
Indication or effect
Hyperkalemia associated with acute and chronic renal failure
Usually, adults 15.51 to 31.02 g per day (3 to 6 capsules of this drug: 15 to 30 g as calcium polystyrenesulfonate) are divided into 2 to 3 times, and their single dose is orally administered with 30 to 50 mL of water.
Incidentally, increase or decrease depending on symptoms.
Careful Administration
Patients easily prone to constipation [intestinal obstruction, intestinal perforation may occur]
Patient with intestinal stenosis [intestinal obstruction, intestinal perforation may occur]
Patients with gastrointestinal ulcers [May cause symptoms to worsen]
Patient with hyperparathyroidism[There is a risk that blood calcium concentration may increase due to ion exchange]
Patients with multiple myeloma[Ion exchange may increase blood calcium concentration]
Serious side effects
Intestinal perforation
Intestinal perforation, intestinal obstruction (frequency unknown) may occur, so observe thoroughly. If abnormality such as advanced constipation suspecting these conditions, persistent abdominal pain, vomiting etc. are observed, stop administration, perform auscultation, palpation, image diagnosis, etc. and take appropriate measures.
Medicinal pharmacology
Potassium exchange capacity
Calcium polystyrene sulfonate contains 7.0 to 9.0% calcium. 1 g is exchanged with potassium of 53 to 71 mg(1.36 to 1.82 mEq/g) in an in vitro test.
Mechanism of action
This drug is not digested and absorbed, it releases calcium ion by itself in the intestinal tract, especially in the lower colon, adsorbs potassium ion and is excreted in feces and removes potassium ion in the intestinal tract out of the body .
Bioequivalence test
Potassium exchange capacity comparison test
As a result of measuring the potassium exchange capacity of this drug and the standard preparation (powder), no significant difference was found between the potassium exchange capacity of both drugs, and the bioequivalence of both drugs was confirmed
Pharmacodynamic test using both nephrectomized rats
As a result of oral administration of this drug and standard formulation (powder) to both nephrectomized rats at 1.5, 3, 6g/kg /day (in terms of calcium polystyrenesulfonate), both agents showed a prolongation effect and serum K + concentration in both nephrectomized rats , And their action strengths were about the same, and the bioequivalence of both drugs was confirmed.
|
