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Micro-pill and preparation method thereof

A technology of pellets and formulations, which is applied in the direction of making medicines into special physical or taking form devices, block delivery, etc., which can solve problems such as adding surfactants.

Active Publication Date: 2012-07-04
JINLING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] There is no report on the addition of surfactants to improve the quality of the pellets and the improved preparation method in the formulation of the pellets

Method used

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  • Micro-pill and preparation method thereof
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  • Micro-pill and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0115] Embodiment 1: the main factor that affects the forming of pill core containing medicine

[0116] In this example, in the case of the selected drug, the solubility of the active ingredient (vitamin C (0.2g / ml, easily soluble), sarcogrelate hydrochloride (0.02g / ml, slightly soluble)), the excipient (microcrystalline cellulose), wetting agent (20% ethanol), surfactant (polysorbate 80), wetting time of soft material (min), extrusion frequency (HZ), sieve aperture (mm), 9 variables such as spheronization time (min), drying temperature (°C) and 2 dummy variables (Dummy) were used in the P-B experimental design (N=12) to investigate the main factors affecting the pellet formation. Wherein, the amount of the active ingredient is the weight ratio of the active ingredient to (the sum of the active ingredient and the excipient), and the amount of the excipient is the weight ratio of the excipient to the (the sum of the active ingredient and the excipient). The amount of agent is ...

Embodiment 2

[0128] Embodiment 2, the main factor that influences blank ball core forming

[0129] In the present embodiment, the formula composed of 3 factors of excipient type, surfactant (polysorbate 80), and sieve plate aperture is selected to carry out 3-level orthogonal experiment (L 9 (3 4 )), wherein, the weight part of the excipient is 1, the weight part of the wetting agent is 0.8, the weight of the surfactant is the weight percentage of the excipient, and the amount of the three factors is enlarged or reduced year-on-year; the preparation process is shown in "implementation Example Explanation"; the factors and levels are shown in Table 4-1, the arrangement of experiments and experimental results are shown in Table 4-2, and the microphotographs of blank pellet cores obtained in each experiment are shown in Table 4-1. Figures 1-1 to 1-9 shown.

[0130] Table 4-1: L9(3 4 ) factor and level table

[0131]

[0132] Table 4-2: L 9 (3 4 ) to arrange experiments, experiment r...

Embodiment 3

[0135] Embodiment 3: The impact of surfactant on the important process in pellet processing

[0136]In the present embodiment, vitamin C (easy to dissolve), taurine (dissolved), and ambroxol hydrochloride (slightly soluble) are respectively used as active ingredients with microcrystalline cellulose (excipient), 20% ethanol (moisturizing wet agent) to form the base formula, and in each base formula, adding and (the sum of active ingredient and excipient) weight percentage are 0, 1, 2, 3, 4, 6, 7% surfactant (polysorbate Ester 80, HLB: 15) form a series of formulas (the active ingredient of formula 1 is vitamin C, the active ingredient of formula 2 is taurine, and the active ingredient of formula 3 is ambroxol hydrochloride), according to the "preparation method" in "Example Description" " and "Procedure Parameters" to prepare bars, observe and calculate the shape of the bars and the yield per unit time, and drop the bars naturally into a 1-meter square plate, and transfer them ...

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Abstract

The invention belongs to the field of pharmacy and discloses a micro-pill and a preparation method thereof. The micro-pill contains the following ingredients in parts by weight: 0 to 100 of active compounds and 0 to 100 of excipient. The proportion of active compounds and the proportion of excipient are not 0 at the same time and the sum of the two is equal to 100, or the proportion of active compounds and the proportion of excipient are proportionally increased or reduced and the proportion of excipient is not 0 when the active compounds are in a liquid state. The content of surfactants is 0.1% to 8% the total weight of active compounds and excipient, and the content of humectants is 0.1% to 30% the total weight of active compounds and excipient. The micro-pill has the advantages of low friability, high yield, small particle size and smooth surface; and can be further processed to micro-pill with functional coating for target drug delivery or micro-pill for drug delivery under special physiological environment conditions.

Description

technical field [0001] The invention belongs to the field of pharmaceuticals, and relates to a pellet and a preparation method thereof. Background technique [0002] The strategy of medicament work for a given active ingredient essentially depends on the therapeutic needs, the physicochemical properties of the active ingredient and the biological environment in which the medicament releases the active ingredient. Therefore, the formulation of the preparation, processing technology and biological environment will determine a successful treatment. [0003] Pellets usually refer to spheroids or spheroids with a diameter of 0.5--1.5mm. Since Nakahara invented the extrusion spheronization technology in 1964, and it was first applied to the field of pharmacy by Reynolds and Conine in 1970, due to extrusion The pellets prepared by the spheronization method have many advantages such as: 1), small geometric size, can be transported from the gastric cavity to the intestinal tract wit...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61J3/06
Inventor 黄春玉邢芸谢俊徐向阳戴银娣曹春林姬晓燕
Owner JINLING PHARMA
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