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Andrographolide-containing taste-masking composition as well as preparation method and application thereof

A technology of andrographolide and composition, which is applied in the field of taste-masking composition containing andrographolide and its preparation, which can solve the problems that the quality of samples cannot be accurately controlled, and andrographolide has no effective preparation, and cannot be industrially and stably produced.

Inactive Publication Date: 2020-10-23
王天怡
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Smaller crystals are coated thicker, and larger crystals are coated thinner, which leads to uneven dissolution and unstable quality of the sample. This method cannot achieve effective coating of andrographolide
[0009] It has been reported that andrographolide and other excipients are coated after wet granulation, but the effect is still poor. The wet granulation particles are large and uneven in size, and the surface of the particles is not smooth.
The quality of the sample is unstable, and such a process cannot be produced stably in an industrialized manner
[0010] In addition, Shi Junhan and others reported the use of β-cyclodextrin inclusion technology to mask the taste of andrographolide, but the inclusion rate of this method is low. Due to the large size of andrographolide, this method cannot Realize industrial production, and the cost is relatively high
[0011] Sun Shasha and others reported using wet granulation process to granulate, and then coated with Eudragit to mask the taste, but this method needs to coat a large amount of coating liquid, and the particles after coating are large and uneven, which affects the efficacy of the drug. Dissolution, so that the quality of the sample cannot be accurately controlled, and due to the large particles, the drug cannot be suspended, and industrial production cannot be realized
[0012] Therefore, there is currently no effective preparation of andrographolide marketed for children

Method used

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  • Andrographolide-containing taste-masking composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] This embodiment provides a taste-masking composition containing andrographolide, which comprises a pill-containing core, a coating layer and a taste-masking layer; the coating layer is arranged on the outer surface of the pill-containing core; the masking The taste layer is arranged on the outer surface of the coating layer. Specifically, the preparation method of the taste-masking composition comprises the following steps:

[0041] S1. Weigh 500g of andrographolide, 300g of polyethylene glycol 4000, 200g of polyethylene glycol 6000, 30g of talcum powder (3000 mesh), 10g of silicon dioxide (1000 mesh), and set aside.

[0042] S2, andrographolide and silicon dioxide are placed in a high-efficiency mixing granulator with a rotating speed of 800rpm and mixed for 10 minutes, and then placed in a high-efficiency mixing granulator with polyethylene glycol 4000, polyethylene glycol 6000, and talc powder at a rotating speed of 800rpm. The mixture was mixed in a granulator for ...

Embodiment 2

[0049] This embodiment provides a taste-masking composition containing andrographolide, which comprises a pill-containing core, a coating layer and a taste-masking layer; the coating layer is arranged on the outer surface of the pill-containing core; the masking The taste layer is arranged on the outer surface of the coating layer. Specifically, the preparation method of the taste-masking composition comprises the following steps:

[0050] S1. Weigh 500g of andrographolide, 500g of polyethylene glycol 6000, 20g of talcum powder (3000 mesh), and 10g of silicon dioxide (1000 mesh), and set aside.

[0051] S2. After mixing andrographolide and silicon dioxide in a high-efficiency mixing granulator with a rotating speed of 800rpm for 10 minutes, they were mixed with polyethylene glycol 6000 and talcum powder in a high-efficiency mixing granulator with a rotating speed of 800rpm for 10 minutes. Next, the mixed material is placed in a stainless steel tray, and the tray is placed in ...

Embodiment 3

[0058] This embodiment provides a taste-masking composition containing andrographolide, which comprises a pill-containing core, a coating layer and a taste-masking layer; the coating layer is arranged on the outer surface of the pill-containing core; the masking The taste layer is arranged on the outer surface of the coating layer. Specifically, the preparation method of the taste-masking composition comprises the following steps:

[0059] S1. Weigh 90g of andrographolide, 400g of polyethylene glycol 4000, 250g of poloxamer 407, 250g of poloxamer 188, and 10g of magnesium stearate for later use.

[0060] S2. Mix andrographolide, magnesium stearate, polyethylene glycol 4000, poloxamer 407, and poloxamer 188 in a high-efficiency mixing granulator with a rotation speed of 600rpm; then, place the mixed material placed in a stainless steel tray, and placed in a 60°C oven for heating to obtain a mixture.

[0061] S3. After cooling the mixture to room temperature, use a swing granu...

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Abstract

The invention is applicable to the technical field of medicines, and provides an andrographolide-containing taste-masking composition as well as a preparation method and application thereof. The taste-masking composition comprises: a medicine-containing pill core, wherein the medicine-containing pill core comprises the following components in percentage by mass: a low-melting-point auxiliary material, a high-melting-point filling agent and andrographolide, the low-melting-point auxiliary material comprises at least one auxiliary material with the melting point of 50-90 DEG C, and the high-melting-point filler comprises at least one auxiliary material of which the melting point is greater than 150 DEG C; a coating layer, wherein the coating layer is arranged on the outer surface of the medicine-containing pill core; and an taste-masking layer, wherein the taste-masking layer is arranged on the outer surface of the coating layer. The taste-masking composition can effectively mask the taste and control the dissolution of medicines, and the taste masking time is long, so that the problem of poor compliance of children due to bitter taste can be effectively solved; and in addition, thetaste masking composition is small and uniform in particle size and convenient for children to take.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a taste-masking composition containing andrographolide, a preparation method and application thereof. Background technique [0002] Antibiotics have many functions such as antibacterial and bactericidal, and can effectively kill bacteria in the body. The overuse of antibiotics leads to the increase of drug resistance is a worldwide problem. There are more than 100 commonly used antibiotics in clinical practice, such as our common acetylspiramycin, amoxicillin, cephalosporin, erythromycin, roxithromycin, tetracycline, norfloxacin, etc. People often use them to treat common ailments such as colds, fevers, and inflammations. However, the instructions of these antibiotics used as "anti-inflammatory" indicate different degrees of adverse reactions, such as gastrointestinal discomfort, fullness and loss of appetite, nausea, vomiting and abdominal pain; tinnitus, dizzines...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/10A61K47/14A61K47/02A61K47/04A61K47/12A61K47/38A61K47/32A61K47/36A61K31/365A61P29/00A61P31/00A61P31/04A61P31/10A61P9/00A61P35/00A61P39/06A61P37/04
CPCA61K9/1682A61K9/1641A61K9/1617A61K9/1611A61K9/1652A61K9/1635A61K31/365A61P29/00A61P31/00A61P31/04A61P31/10A61P9/00A61P35/00A61P39/06A61P37/04
Inventor 王天怡姜海涛
Owner 王天怡
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