Pharmaceutical composition containing diuretic

A composition and drug technology, applied in the field of pharmacy, can solve the problems of increased risk of heart failure, dyspnea, etc., and achieve the effects of convenient medication, increased curative effect, and low dosage

Active Publication Date: 2021-03-30
SHENZHEN AUSA PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The incidence of edema caused by taking sitaxsentan 100mg is about 9%, and fluid retention can also lead to coughing, dyspnea, increased risk of heart failure, etc.

Method used

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  • Pharmaceutical composition containing diuretic
  • Pharmaceutical composition containing diuretic
  • Pharmaceutical composition containing diuretic

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 7-10

[0031] Embodiment 7-10 prepares macitentan, folic acid and indapamide (1000 tablets)

[0032]

[0033]

[0034] Preparation Process:

[0035] Mix macitentan, folic acid and indapamide, add carboxymethyl starch sodium and sodium lauryl sulfate, then add microcrystalline cellulose and pregelatinized starch and mix evenly, and use an appropriate amount of 10% povidone The ethanol solution is made into a soft material, granulated, dried, and granulated, and the granules with a water content of about 3% are evenly mixed with an appropriate amount of magnesium stearate, and compressed into 1,000 tablets.

Embodiment 11

[0036] Example 11: Efficacy and safety evaluation of macitentan / folic acid / indapamide in the treatment of rats with pulmonary arterial hypertension

[0037] (1) Method

[0038] Experimental modeling: 70 male SD rats were adaptively fed for one week, and 10 rats without any treatment were used as the normal control group. The rest of the rats were given intraperitoneal injection of 0.5ml monocrotaline (MCT) 60mg / kg once, two weeks later the rats with pulmonary hypertension were formed, and then they were randomly divided into groups.

[0039] Experimental grouping and dosing regimen: normal control group (n=10), the rats after modeling were randomly divided into model group and drug administration group, the specific grouping and dosage are shown in Table 1, each group after 4 weeks of intragastric administration After fasting overnight, the hemodynamics of each group were measured 48 hours after drug withdrawal, including right atrial pressure and mean pulmonary artery pressu...

Embodiment 12

[0050] Example 12: Clinical trials of macitentan / folic acid / indapamide in the treatment of pulmonary arterial hypertension

[0051] (1) Method

[0052] Patient source: 43 patients with pulmonary arterial hypertension admitted to the Department of Cardiovascular Medicine of a hospital from January 2015 to January 2017 were used as research objects. All patients underwent pulmonary artery pressure testing through right heart catheterization, all of which conformed to the 2009 American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) jointly issued diagnostic criteria for pulmonary hypertension.

[0053] Patient exclusion criteria: exclude those who meet any of the following:

[0054] ①Patients with various types of congenital heart defects; ②Patients with PAH closely related to factors other than congenital heart disease, such as genetics or HIV; ③Patients with confirmed pulmonary embolism or pulmonary parenchymal diseases; ④Combined with tumors,...

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PUM

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Abstract

The invention provides a pharmaceutical composition for treating pulmonary arterial hypertension. The pharmaceutical composition is composed of a therapeutically effective amount of a dual endothelinreceptor antagonist, a folic acid substance, indapamide and a pharmaceutically acceptable carrier. The pharmaceutical composition provided by the invention can effectively reduce pulmonary arterial hypertension, and can reduce the side effects of a single active component; and in addition, the pharmaceutical composition can be conveniently taken by the patient, and the compliance is improved.

Description

technical field [0001] The invention provides a pharmaceutical composition for treating pulmonary hypertension, which consists of dual endothelin receptor antagonists, folic acid substances, indapamide and pharmaceutically acceptable carriers. The present invention belongs to the field of pharmacy. Background technique [0002] Pulmonary arterial hypertension (PAH) refers to a disease state in which the mean pulmonary arterial pressure is ≥25mmHg (1mmHg=0.133kPa) and the pulmonary capillary wedge pressure is ≤15mmHg in a resting state. PAH is usually progressive and seriously endangers human health. The etiology of PAH is idiopathic, hereditary, induced by drugs or poisons, connective tissue disease, human immunodeficiency virus (HIV) infection, portal hypertension, systemic-pulmonary shunt and other reasons. The basic pathological changes of pulmonary hypertension are progressive vascular endothelium, smooth muscle hyperplasia and hypertrophy, fibrosis, vasoconstriction a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/404A61K31/506A61K31/519A61P9/12A61P11/00
CPCA61K45/06A61K31/404A61K31/506A61K31/519A61P9/12A61P11/00A61K2300/00
Inventor 白洁于多黄晓杰张朝当田敏卿
Owner SHENZHEN AUSA PHARM CO LTD
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