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A kind of andrographolide dispersible tablet and preparation method thereof

A technology of andrographolide and dispersible tablets, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problem of affecting the dissolution rate and uniformity of drugs and the low solubility of andrographolide , andrographolide photoinstability and other problems, to achieve good coating light-proof effect, good taste-masking effect, and easy-to-control process parameters

Active Publication Date: 2017-05-10
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to the low solubility of andrographolide in water, the taste is extremely bitter, and it is unstable to light, the main problems in the application are: the dissolution rate is slow, which affects the rapid development of the curative effect; Bitterness can lead to vomiting, epigastric discomfort, loss of appetite and other adverse reactions. Mild cases manifest as abdominal pain, vomiting, asthma, urticaria, pimples, and severe reactions may even cause chest tightness, shortness of breath, cold sweats, weak pulse, and drop in blood pressure; Andrographis paniculata Ester is photo-instability, which puts forward higher requirements for its preparation process and application
[0005] The oral solid preparations of andrographolide disclosed in the current literature are all single-unit drug-release preparations. After taking it, only by disintegrating the core rapidly through disintegration can a good drug-release rate be achieved. If the drug core cannot be dispersed well due to the influence of other factors, the release behavior of the drug will change greatly, and the dissolution rate cannot be effectively guaranteed.
In addition, the surface disintegration of the single-unit drug-release preparation is usually faster in the early stage, and then due to the weak internal capillary action and the influence of the coverage and deposition of the disintegrated drug on the surface, the internal tablet core mass is often difficult to disintegrate. Affect drug dissolution rate and dissolution uniformity

Method used

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  • A kind of andrographolide dispersible tablet and preparation method thereof
  • A kind of andrographolide dispersible tablet and preparation method thereof
  • A kind of andrographolide dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～3

[0048] The preparation of embodiment 1~3 andrographolide pellets

[0049] Table 1

[0050]

[0051] Preparation:

[0052] 1. Andrographolide pellets

[0053] Weigh andrographolide, microcrystalline cellulose, lactose, croscarmellose sodium / crospovidone / low-substituted hydroxypropyl cellulose according to the prescription, mix well, add 5% povidone K 30 The soft material is prepared from an aqueous solution, and placed in an extrusion spheronizer to prepare andrographolide-containing pill cores, which are taken and dried at 60-70°C until the moisture content is ≤3.0%, and 24-40 mesh ball cores are sieved to obtain andrographolide-containing pills core.

[0054] Weigh the prescribed amount of talcum powder and titanium dioxide and add it to pure water, homogenize it with a homogenizer to make a suspension, add the coating material (Kollicoat IR) to the suspension before coating, stir, mix evenly, pass 40 mesh sieve to obtain the coating solution.

[0055] Put the androgr...

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Abstract

The invention relates to an andrographolide dispersible tablet prepared in a pellet tableting process. The andrographolide dispersible tablet is characterized in that the tablet is composed of an andrographolide pellet and a blank pellet tablet, and the mass ratio of the andrographolide pellet to the blank pellet tablet is 1:0.75-1:1.05. The andrographolide pellet is composed of andrographolide, filler, an adhesion agent, corrigent and a disintegrating agent. An extrusion rolling method is used for preparing a pellet core containing medicine, and then a fluidized bed coating technology is used for enabling the pellet core to be coated with a polyving akohol-polyethylene glycol copolymer to form the andrographolide pellet. The blank pellet tablet is composed of filler, an adhesion agent, a disintegrating agent and a coloring agent, and an extrusion rolling method is used for preparing the blank pellet tablet. The andrographolide pellet and the blank pellet tablet are pressed to be tablet after being mixed evenly in proportion, and the andrographolide dispersible tablet can be obtained. The andrographolide dispersible tablet is quick, effective, safe, free of discomfortable bitter taste, and flexible in dosage.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a dispersible andrographolide tablet produced by a pellet compression process and a preparation method thereof. Background technique [0002] Andrographolide is one of the main active ingredients in the traditional Chinese medicine Andrographis paniculata. It belongs to diterpene lactone compounds. The structural formula is shown in the following formula. The molecular formula is C 20 h 20 o 5 . The compound is off-white crystal, odorless, bitter in taste, slightly soluble in methanol or ethanol, almost insoluble in water. Modern pharmacological studies have shown that andrographolide has special effects on bacterial and viral upper respiratory tract infections and dysentery. . As a traditional Chinese medicine antibiotic, andrographolide has the characteristics of high efficiency, low toxicity and safety in clinical application. [0003] D...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/26A61K31/365A61K47/38A61P11/00A61P31/04A61P1/12
CPCY02A50/30
Inventor 赵新慧徐卓业祁艳
Owner NANJING ZENKOM PHARMA
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