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Pharmaceutical composition containing berberine and application of pharmaceutical composition

A composition, the technology of berberine, applied in the field of pharmaceutical composition for the treatment of hyperlipidemia, achieves the effects of reducing the dosage of a single drug, significant curative effect, and low liver toxicity

Pending Publication Date: 2021-07-20
深圳市长卿医学研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The most commonly used lipid-lowering drugs in clinical practice are statins. Clinical application shows that statins can effectively reduce the level of LDL-c, but their side effects gradually appear with the increase of dose and the prolongation of taking time, such as liver toxicity, Rhabdomyolysis, etc.

Method used

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  • Pharmaceutical composition containing berberine and application of pharmaceutical composition
  • Pharmaceutical composition containing berberine and application of pharmaceutical composition
  • Pharmaceutical composition containing berberine and application of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-2

[0022] Embodiment 1-2: the preparation of berberine, Bempedoic Acid composite sheet (1000)

[0023] Formula composition Example 1 Example 2 berberine 50g 100g Bempedoic Acid 120g 180g pregelatinized starch 46g 50g microcrystalline cellulose 68g 72g Carboxymethyl Starch Sodium 3g 5g Sodium dodecyl sulfate 2.6g 3.6g 10% Povidone K30 Appropriate amount Appropriate amount Magnesium stearate 1.2g 1.2g

[0024] Preparation process: mix berberine and Bempedoic Acid, add sodium carboxymethyl starch and sodium lauryl sulfate, then add microcrystalline cellulose and pregelatinized starch, mix evenly, and use an appropriate amount of 10% povidone K30 ethanol The 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 3-4

[0025] Embodiment 3-4: Preparation of berberine+Bempedoic Acid composite capsules (1000 capsules)

[0026] Formula composition Example 3 Example 4 berberine 50g 100g Bempedoic Acid 150g 150g lactose 60g 66g microcrystalline cellulose 85g 90g Sodium dodecyl sulfate 8g 8g Croscarmellose Sodium 4.5g ,5.0g 5% hypromellose solution Appropriate amount Appropriate amount Magnesium stearate 2g 2g

[0027] Preparation process: pass sodium carboxymethyl starch through a 100-mesh sieve, and pass lactose and microcrystalline cellulose through a 80-mesh sieve for later use; mix the raw material with croscarmellose sodium and sodium lauryl sulfate, and then add microcrystalline Mix cellulose and lactose, granulate with 5% hypromellose solution, dry at 50-60°C for 2 hours, mix the prepared material with magnesium stearate, and fill it with No. 1 capsule. Make 1000 capsules.

Embodiment 5--6

[0028] Embodiment 5--6: the preparation of berberine+Bempedoic Acid granule (1000 bag quantities)

[0029] Formula composition Example 5 Example 6 berberine 50g 100g Bempedoic Acid 120g 180g lactose 80g 80g pregelatinized starch 100g 100g Carboxymethyl Starch Sodium 15g， 15g aspartame 5g 5g 5% Povidone K-30 Appropriate amount Appropriate amount Magnesium stearate 0.5％ 0.5％

[0030] Preparation process: (1) Weigh the prescribed amount of berberine and Bempedoic Acid, pass through a 100-mesh sieve and mix them evenly for later use; (2) Pass other auxiliary materials through a 100-mesh sieve respectively for later use; (3) Weigh out the prescribed amount of lactose, Pregelatinized starch, carboxymethyl starch sodium and aspartame are mixed evenly and then mixed with the mixed raw materials; (4) Add appropriate amount of binder to make soft material, granulate with 24 mesh sieve, and dry at 40-45°C (5) 20-m...

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Abstract

The invention provides a pharmaceutical composition for treating hyperlipidemia. The pharmaceutical composition is prepared from berberine and Bempedoic Acid. The invention provides an effective pharmaceutical composition for synergistically reducing blood fat for patients with hyperlipidemia, and the pharmaceutical composition is especially suitable for patients with liver dysfunction and also has an anti-inflammatory effect.

Description

technical field [0001] The invention provides a pharmaceutical composition for treating hyperlipidemia, which consists of Bempedoic Acid and berberine. belongs to the field of pharmacy. Background technique [0002] With the continuous development of social living standards, the continuous improvement of people's quality of life, changes in diet structure, high-fat and high-calorie diets have gradually become the norm, and modern people are busy with work, lack of exercise time, and are in a sub-healthy state for a long time. The frequency of cardiovascular events continues to increase, generally manifested as hyperlipidemia, diabetes, atherosclerosis, gastrointestinal inflammation, and decreased immune function. [0003] From 2013 to 2014, the China Chronic Disease and Risk Factor Surveillance Survey (CCDRFS) survey of 163,641 Chinese adults in 31 provinces in China showed that serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and ), triglyceride (...

Claims

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Application Information

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IPC IPC(8): A61K31/20A61K31/4375A61P3/06A61P1/16
CPCA61K31/20A61K31/4375A61P3/06A61P1/16A61K2300/00
Inventor 李锦良白洁邢厚恂张朝当
Owner 深圳市长卿医学研究院
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