Pharmaceutical compositions and applications thereof, and pharmaceutical preparation
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A technology of pharmaceutical preparations and compositions, applied in the fields of compositions and their uses, and pharmaceutical preparations, which can solve problems such as severe liver cirrhosis and multiple side effects
Inactive Publication Date: 2017-05-24
SHENZHEN HIGHTIDE BIOPHARM
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Existing treatments for type 2 diabetes are often associated with adverse effects
However, NASH can be severe when the liver is permanently damaged, scarred and no longer working well, possibly leading to cirrhosis
[0014] Currently, there are no approved drugs for the treatment of NASH, which occurs in one in four patients with NAFLD
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Embodiment 1
[0115] Example 1: Pharmacokinetics of berberine (BBR) and EPA / DHA formulations in rats and dogs learning situation
[0116] This example describes the pharmacokinetics of BBR and EPA and / or DHA formulations in rats and dogs.
[0117] Male SD rats, weighing 210-250g, were randomly divided into the following 3 groups after 7 days of adaptive feeding, with 3 rats in each group.
[0118]
[0119] Rats in each group were given the corresponding test substance suspended in 0.5% tragacanth gum by intragastric administration once. Blood samples (about 400 μL) were collected before administration and 15min, 30min, 1h, 1.5h, 2h, 4h, 8h and 24h after administration, placed in an anticoagulant tube containing sodium heparin, and centrifuged at 8000rpm, 4°C for 6 Plasma was separated within minutes, and samples were stored at -80°C until analysis.
[0120] The plasma concentration of BBR was determined and analyzed by tandem mass spectrometry (LC-MS / MS). use Professional5.2 (Ph...
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Abstract
The invention relates to pharmaceutical compositions and applications thereof, and a pharmaceutical preparation. The invention provides various novel compositions of berberine in combination with pharmacologically active EPA and DHA, and related methods of their use in treating various diseases or disorders. The pharmaceutical compositions of the invention are useful in treating and / or preventing various diseases or disorders, including metabolic diseases or disorders such as dyslipidemia, hyperglycemia, hypertriglyceridemia, hyperlipidemia, diabetic dyslipidemia, diabetic hyperlipidemia, dyslipidemia in statin-intolerance patients, diabetes, diabetic complications, hypercholesterolemia, or obesity. Additionally, the pharmaceutical compositions of the invention are useful in treating and / or preventing atherosclerosis, heart diseases, neurodegenerative diseases, inflammation, cancers, as well as various liver diseases or disorders, such as fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, cholestatic liver diseases or graft-versus-host disease of the liver. Furthermore, the pharmaceutical compositions of the invention are useful in improving liver functions in chronic viral associated liver diseases and alcohol-related liver diseases.
Description
[0001] This application is based on, and claims priority from, an earlier US Provisional Application filed November 13, 2015 (Application No. US 62 / 254,739), the entire content of which is incorporated herein by reference. technical field [0002] The present invention mainly relates to the novel composition and its preparation method, therapeutic use and the like. In particular, the present invention relates to novel compositions of berberine (BBR) and omega-3 fatty acids, including eicosapentaenoic acid (EPA) and / or docosahexaenoic acid (DHA), Or its esters, and uses. The composition of the present invention is used to treat and / or prevent patients with hyperlipidemia including, for example, dyslipidemia, hyperglycemia, hypertriglyceridemia, hyperlipidemia, diabetic dyslipidemia, diabetic hyperlipidemia, and statin intolerance , diabetes, diabetes complications hypercholesterolemia or obesity and other metabolic diseases or disorders including a variety of diseases or disor...
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