Preparation method of puerarin sustained-release dropping pill

A technology for sustained-release and sustained-release dropping pills of puerarin, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc. problems such as high irritation, to achieve broad development and application prospects, great clinical application value, and the effect of improving medication compliance

Inactive Publication Date: 2015-05-20
TAIYUAN INST OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets disintegrate slowly after oral administration, and the dissolution is poor, so that the drug effect cannot be fully exerted; powders have a large dispersion surface after oral administration, and the irritation is also large; injections are difficult to reverse their physiological effects after injection, and the injection is painful. Inconvenient to wait
Therefore, the currently commercially available puerarin dosage forms have certain defects.

Method used

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  • Preparation method of puerarin sustained-release dropping pill
  • Preparation method of puerarin sustained-release dropping pill
  • Preparation method of puerarin sustained-release dropping pill

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The preparation method of the puerarin sustained-release dropping pills in the present embodiment, its concrete steps are as follows:

[0028] (1) Precisely weigh the hydrophobic matrix and the hydrophilic matrix according to the proportion, fully melt and mix them under the condition of heating in a water bath, then add puerarin powder according to the proportion, stir continuously for 30 minutes under the condition of heating, and fully mix evenly;

[0029] (2) Start the dripping pill machine, preheat for 30 minutes, set the temperature of the feed liquid in the instrument, the temperature of the chassis of the feed filling and the condensation temperature or the cooling temperature, and start the control buttons of each temperature to make it reach the displayed value; the temperature of the feed liquid and the temperature of the chassis should be consistent;

[0030] (3) Start the stirring system of the dripping pill machine, control the stirring speed, enter the fe...

Embodiment 2

[0065] Under the optimal preparation process conditions in Example 1, three batches of puerarin sustained-release dripping pills were respectively prepared, the batch numbers were: 14042501, 14042502, 14042503, and the roundness, weight difference, and drug loading rate were used as investigation indicators. [17] , for investigation, the results are shown in Table 6.

[0066] Table 6 Determination results of three batches of puerarin sustained-release dropping pills

[0067]

[0068] The results show that the RSD values ​​of the weight difference, roundness and drug loading rate of the sustained-release dropping pills prepared under the optimal preparation process conditions of the three batches are all less than 2%. It means that all of them meet the requirements of the Pharmacopoeia, and it can be verified that the optimal preparation process conditions are stable and feasible.

Embodiment 3

[0070] In this embodiment, 0.9% sodium lauryl sulfate solution is used as the release medium, and the dissolution volume is 900mL, which is injected into each dissolution cup, and the temperature of the dissolution tester is adjusted to 37±0.5°C. At (37±0.5)°C, the rotation speed is 100r / min, and the dissolution time is set to 12h. A blank sustained-release dropping pill was used as a control.

[0071] Get each 15 of 3 batches of puerarin sustained-release dripping pills prepared under the best preparation process conditions in Example 1, the total weight is respectively 0.510g, 0.489g, 0.497g, drop into 3 drying baskets, take blank Several slow-release dropping pills, with a total weight of 0.431g, were put into the rotating basket and placed in the dissolution cup as a blank control. Immediately start the rotation and start timing, take samples after 2h, 4h, 6h, 8h, 10h, and 12h, and absorb 5mL of the solution each time. After sampling, add 5mL of 0.9% sodium dodecyl sulfat...

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Abstract

The invention relates to a preparation method of a puerarin sustained-release dropping pill. The method comprises the following steps: (1) weighing hydrophobic matrix and hydrophilic matrix, fully melting and mixing evenly under a water bath heating condition, adding puerarin powder and mixing evenly; (2) starting the dropping pill, and preheating for 30 minutes; (3) starting a pill dropping machine stirring system and stirring for 10 minutes; (4) turning on a condensate liquid level adjusting knob and adjusting the dropping distance; (5) mounting a dripping head in a pill dropping machine; (6) dropping a liquid medicine into condensate; (7) collecting sustained-release dropping pills; and (8) sucking up condensate on the surfaces of the sustained-release dropping pills with filter paper and medical gauze, so as to obtain the puerarin sustained-release dropping pills. An optimal preparation technology of the novel puerarin sustained-release dropping pill is optimized; the targets of delaying drug release and reducing toxic and side effects can be reached; meanwhile, the medication frequency can be reduced; the medication compliance of patients is improved; the method has relatively large application value; and important reference is provided for pharmaceutical companies and clinical research and development.

Description

technical field [0001] The invention relates to a preparation method of puerarin sustained-release dripping pills, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Puerarin, also known as Puerarin flavonoids, is extracted from Pueraria lobata root. Its molecular formula is C21H20O9. It is slightly soluble in water. It can improve cardiovascular and cerebrovascular circulation, lower blood sugar, resist high blood pressure and arteriosclerosis, and improve the body’s immunity. Biologically active, it also has the effects of improving eyesight, rapidly sobering up and estrogen. It is widely used clinically in patients with high incidence of coronary heart disease, angina pectoris, myocardial infarction, retinal arteriovenous occlusion, sudden deafness, ischemic cerebrovascular disease, viral myocarditis in children, diabetes, etc. The main dosage forms of puerarin currently on the market are tablets, powders and injections. Table...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/352A61K47/12A61K47/34A61P9/10A61P27/16A61P31/12A61P9/00A61P3/10
Inventor 孟戎茜王曼王慧芳邵圣娟邢小琴
Owner TAIYUAN INST OF TECH
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