Vitamin C sustained-release pellets and method for preparing same

A technology of slow-release pellets and vitamins, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, block delivery, etc. It can solve the problems of unfavorable capsule filling, long time consumption, poor patient compliance, etc., and achieve unit volume The effect of large drug loading, simple product prescription, and short operation time

Active Publication Date: 2013-02-06
SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This has brought many defects: on the one hand, the patient's compliance is poor, and at the same time, there are often missed doses
Its disadvantages are: (1) metal chelating agents are used in the prescription, which increases the complexity of the prescription; (2) 20% shellac ethanol is used in the process of preparing vitamin C pellets, because ethanol is flammable and explosive , which greatly improves the requirements for the production environment (3) Due to the use of blank pellet cores, the drug loading of vitamin C per unit volume is less, and the content and content uniformity of vitamin C in vitamin C pellets are uniform hard to control
Its disadvantages are: (1) the prescription contains antioxidants and antioxidant synergists (metal chelating agents), in addition to porogens and defoamers, which undoubtedly increases the complexity and production costs of the prescription; ( 2) When preparing vitamin C sustained-release pellets, dissolving all vitamin C in water greatly reduces the stability of vitamin C. Although metal chelating agents and antioxidants are added to the solution, the liquid layer It takes too long to prepare the pellets by the active method, which leads to the easy degradation of vitamin C
(3) Due to the use of blank pellet cores, on the one hand, the drug loading of vitamin C per unit volume is less, which is not conducive to capsule filling; on the other hand, it is difficult to control the content and content uniformity of vitamin C in vitamin C pellets

Method used

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  • Vitamin C sustained-release pellets and method for preparing same
  • Vitamin C sustained-release pellets and method for preparing same
  • Vitamin C sustained-release pellets and method for preparing same

Examples

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preparation example Construction

[0019]A vitamin C sustained-release pellet, consisting of a vitamin C vegetarian pill and a slow-release coating layer 3, the vitamin C vegetarian pill is composed of a mother core 1 and a laminated layer 2, and the vitamin C vegetarian pill is composed of a vitamin C and vitamin C vegetarian pill auxiliary materials, or the vitamin C vegetarian pills are composed of vitamin C, and the slow-release coating layer 3 is composed of slow-release coating materials and slow-release coating layer auxiliary materials, or the slow-release coating layer Release coating layer 3 is made up of sustained-release coating material, and described vitamin C vegetarian pellet supplementary material is selected from one or both of fillers, binders, and described sustained-release coating layer supplementary material is selected from plasticizing One or both of anti-adhesive agent and anti-adhesive agent; the weight percentage content of vitamin C in the mother core 1 and laminated layer 2 is the s...

Embodiment 1

[0028] Vitamin C Sustained Release Pellets Prescription

[0029] Vitamin C pill prescription:

[0030] Vitamin C 1000g

[0031] Hydroxypropyl Methyl Cellulose 5g

[0032] ER Coating 3 Prescription:

[0033] Su Lisi (solid content) 42g

[0034] Preparation Process:

[0035] (1) Crush and sieve vitamin C.

[0036] (2) Prepare the prescribed amount of hydroxypropyl methylcellulose with water to make a 3% aqueous solution of hydroxypropyl methylcellulose as a binding solution.

[0037] (3) Weigh vitamin C according to the prescription amount as a vegetarian pill powder

[0038] (4) Take part of the above-mentioned vegetarian pill powder and binding liquid, and use a wet granulator to prepare vitamin C wet granules. The particle size is guaranteed to be about 40 mesh, and it is dried to ensure that the moisture content after drying is less than 2.0%. 1. Wet granulation process parameters: Stirring speed: 45HZ, granulation speed 45HZ, wet mixing time 1-3 minutes.

[0039]...

Embodiment 2

[0044] Vitamin C Sustained Release Pellets Prescription

[0045] Vitamin C pill prescription:

[0046] Vitamin C 800g

[0047] Microcrystalline Cellulose 200g

[0048] Hydroxypropyl methylcellulose (10cp) 16.5g

[0049] ER Coating 3 Prescription:

[0050] Ethyl cellulose (10cp) 80g

[0051] Triethyl citrate 8g

[0052] Preparation Process:

[0053] (1) Crush and sieve vitamin C.

[0054] (2) Prepare the prescribed amount of hydroxypropyl methylcellulose with water to make a 3% aqueous solution of hydroxypropyl methylcellulose as a binding solution.

[0055] (3) Weigh vitamin C and microcrystalline cellulose according to the prescription amount, mix them evenly, and use them as vegetarian pill powder.

[0056] (4) Take part of the above-mentioned vegetarian pill powder and binding liquid, and use a wet granulator to prepare vitamin C wet granules, with a particle size of about 60-40 mesh, and dry them to ensure that the moisture after drying is less than 2.0%. core 1. ...

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Abstract

A vitamin C sustained-release pellet applied to the vitamin C sustained-release preparation field and a method for preparing the same are disclosed. The vitamin C sustained-release pellet is composed of a vitamin C sustained-release pill and a sustained-release coating, wherein the vitamin C sustained-release pill is composed of a mother nucleus and a lamination layer, or composed of a vitamin C and vitamin C pill accessory, or composed of vitamin C; the sustained-release coating is composed of a sustained-release coating material and a sustained-release coating accessory, or composed of the sustained-release coating material; the vitamin C sustained-release pill accessory is one or two selected from a filler and a binder; the sustained-release coating accessory is one or two selected from a plasticizer and an antisticking agent; the weight percentage content of the vitamin C in the mother nucleus is the same as that in the lamination layer; and the filler is one or several selected from microcrystalline cellulose, powdered sugar, starch, dextrin and lactose. The vitamin C sustained-release pellet disclosed by the invention is simple in prescription, free of metal-chelator or antioxidant, great in unit volume drug loading capacity, good in stability and capable of keeping sustained release for a long time; and the preparation method of the vitamin C sustained-release pellet is short in operation time and low in cost.

Description

technical field [0001] The invention relates to the field of vitamin C sustained-release preparations, in particular to a vitamin C sustained-release pellet and a preparation method thereof. Background technique [0002] Vitamin C (Vitamin C, Ascorbic Acid), also known as L-ascorbic acid, is a water-soluble vitamin. 30% of people in my country have insufficient vitamin C intake, that is, 400 million people lack vitamin C. They need to supplement or take vitamin C related products to maintain normal physiological needs and ensure good health. Therefore, the research and development of vitamin C and related preparations is very urgent and necessary. According to scientific research results, oral vitamin C is usually absorbed in the upper small intestine (duodenum and upper jejunum), and only a small amount is absorbed by the stomach, while a small amount is also absorbed by the mucous membranes in the mouth. The absorption process is an active transport process, and the abso...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/375A61P3/02
Inventor 王慧颖陈雅琴任乃刚李想崔广泉鲍辉李芳石秀芹李青郭凤尧周联波
Owner SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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