Puerarin liquid formulation and preparation method thereof

A liquid preparation, puerarin technology, applied in blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., can solve problems such as allergies, pyrogens, tumor-like reactions, adverse reactions of propylene glycol, pollution particles and impurities, etc., to overcome adverse reactions Many factors, easy production operation and control, low content effect

Active Publication Date: 2009-04-29
上海华源药业(宁夏)沙赛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. Puerarin is a drug extracted from plants and semi-synthesized. Its raw materials may contain macromolecular plant proteins, which may cause adverse reactions;
[0005] 2. Some injection prescriptions contain a large amount of solubilizer propylene glycol, which can cause adverse reactions;
However, activated carbon has a charge. After entering the injection, it will disperse in the water for injection to form a colloidal solution, which can pass through the filter rod or filter membrane, so that the injection will be contaminated with new particulate impurities. Such particles cannot be metabolized in the body, so it may cause granulation. Swelling, pulmonary edema, phlebitis, thrombosis, tissue necrosis, allergies, pyrogens, tumor-like reactions, etc.

Method used

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  • Puerarin liquid formulation and preparation method thereof
  • Puerarin liquid formulation and preparation method thereof
  • Puerarin liquid formulation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1, the preparation of puerarin injection

[0033] One, the preparation of puerarin injection

[0034] In the aseptic operation room, dissolve 1 g of puerarin in water for injection at 80° C., then add 4 g of sodium chloride and stir until fully dissolved to obtain solution I; adjust the pH value of solution I to 5.0 with 10% hydrochloric acid solution;

[0035] In the aseptic operation room, the temperature of the above-mentioned solution I was lowered to 40°C, and then the solution I was filtered with a 0.22 μm filter to obtain the filtrate a; the filtrate a was ultrafiltered with an ultrafiltration membrane with a molecular weight cut-off of 10,000 Daltons, Obtain filtrate b; make up the filtrate b to 1000ml with water for injection, and then filter with a 0.22 μm filter to obtain filtrate c; then filter the filtrate c with a 0.22 μm filter to obtain filtrate d.

[0036] The filtrate d is inspected for the following indicators: puerarin content, content of...

Embodiment 2

[0072] Embodiment 2, the preparation of puerarin infusion

[0073] The preparation process is carried out in the 10,000-class clean area, and the filling process is carried out under the local 100-class clean area of ​​the 10,000-class clean area.

[0074] One, the preparation of puerarin infusion

[0075] In the aseptic operation room, dissolve 2g of puerarin in water for injection at 80°C, then add 50g of glucose and stir until fully dissolved; obtain solution I; adjust the pH value of solution I to 5.1 with 10% glacial acetic acid solution;

[0076] In the aseptic operation room, the temperature of the above-mentioned solution I was lowered to 45°C, and then the solution I was filtered with a 0.22 μm filter to obtain the filtrate a; the filtrate a was ultrafiltered with an ultrafiltration membrane with a molecular weight cut-off of 10,000 Daltons, Obtain filtrate b; make up the filtrate b to 1000ml with water for injection, and then filter with a 0.22 μm filter to obtain f...

Embodiment 3

[0104] Embodiment 3, the preparation of puerarin infusion

[0105] The preparation process is carried out in the 10,000-class clean area, and the filling process is carried out under the local 100-class clean area of ​​the 10,000-class clean area.

[0106] One, the preparation of puerarin infusion

[0107] In the aseptic operation room, dissolve 2g of puerarin in water for injection at 90°C, then add 9g of sodium chloride and stir until fully dissolved to obtain solution I; adjust the pH value of solution I to 5.2 with 10% hydrochloric acid solution;

[0108] In the aseptic operating room, the temperature of the above solution I was lowered to 42°C, and then the solution I was filtered with a 0.22 μm filter to obtain the filtrate a; the filtrate a was ultrafiltered with an ultrafiltration membrane with a molecular weight cut-off of 10,000 Daltons, Obtain filtrate b; make up the filtrate b to 1000ml with water for injection, and then filter with a 0.22 μm filter to obtain filt...

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Abstract

The invention discloses a puerarin liquid preparation and a preparation method thereof. The method comprises the following steps: puerarin is dissolved in water and then added with an iso-osmotic regulator, thus obtaining a solution I by mixing evenly; the solution I is filtered with the aperture of 0.22 Mum, thus obtaining a filtering solution a; the filtering solution a is treated with ultrafiltration by an ultrafiltration membrane with the MWCO of 10000 Dalton, thus obtaining a filtering solution b; the filtering solution b is filtered by the aperture of 0.22 Mum, thus obtaining a filtering solution c; and the filtering solution c is filtered by the aperture of 0.22 Mum, thus obtaining the puerarin liquid preparation. The preparation method of the puerarin liquid preparation overcomes the defect that the existing preparation has a plurality of untoward reaction factors. Experiments prove that the preparation prepared by the method does not contain a solubilizing agent, the content of other particles and bacteria is low, the puerarin has high purity and good stability; in addition, products of each batch produced by the method of the invention meet quality standards, have batch to batch stability and reliable quality; the method of the invention has simple process and is convenient for production operation and control and suitable for mass production.

Description

technical field [0001] The invention relates to a puerarin liquid preparation and a preparation method thereof. Background technique [0002] Puerarin (Pur), the chemical name is 4,7-dihydroxy-8-β-D-glucosyl isoflavone, and the relative molecular weight is 416. Puerarin is an active ingredient in the traditional Chinese medicine Pueraria lobata, which can be extracted from the roots of the leguminous plant Pueraria mirifica or Pueraria lobata. Puerarin is better than nitrates in dilating blood vessels and lowering blood pressure, because it can slow down the heart rate and reduce myocardial oxygen consumption when dilating blood vessels and lowering blood pressure. Puerarin can also reduce platelet surface activity, inhibit platelet adhesion and aggregation, resist thrombosis, and improve microcirculation. Puerarin has a good curative effect in the treatment of coronary heart disease, angina pectoris, hypertension, nephrotic syndrome, heart failure, ischemic cerebrovascula...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7048A61P9/00A61P7/02C07H17/07
Inventor 刘伟强芦莉娜侯辉
Owner 上海华源药业(宁夏)沙赛制药有限公司
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