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Enteric coated tablet containing sertraline hydrochloride and preparation method thereof

A technology of sertraline hydrochloride and enteric-coated tablets, which is applied in the direction of medical preparations containing active ingredients, medical preparations without active ingredients, and pill delivery, which can solve the problems of low dissolution rate and stability, high requirements for excipients, and technical problems. Complexity and other issues, to achieve the effect of low price of excipients, reduction of adverse reactions and simple process

Inactive Publication Date: 2019-03-08
乐普制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the sertraline sustained-release preparation still has relatively large side effects, and the dissolution rate and stability are low. In addition, the process of the sertraline sustained-release preparation is more complicated, and the required auxiliary materials are high in requirements and high in price.

Method used

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  • Enteric coated tablet containing sertraline hydrochloride and preparation method thereof
  • Enteric coated tablet containing sertraline hydrochloride and preparation method thereof
  • Enteric coated tablet containing sertraline hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027]

[0028]

[0029] Its preparation method is

[0030] (1) the sertraline hydrochloride of prescription quantity and the lactose of prescription quantity, dibasic calcium phosphate dihydrate, croscarmellose sodium, hypromellose and magnesium stearate are mixed in mixer for 10min, obtain Intermediates after total blending;

[0031] (2) The intermediate after the total mixing is pressed into tablets according to the weight of the theoretical tablet to obtain plain tablets;

[0032] (3) methacrylic acid copolymer, triethyl citrate, Tween 80 and talcum powder of recipe quantity are dissolved in 80% ethanol, the coating liquid of preparation concentration 8%; And coating liquid is added coating machine Inside;

[0033] (4) Put the sertraline hydrochloride tablets into the coating pan, preheat, and when the tablet bed temperature reaches 40°C, spray the slurry, control the tablet bed temperature to about 40°C, and the coating liquid flow rate to be 40g / min. The surface...

Embodiment 2

[0035]

[0036] Its preparation method is

[0037] (1) microcrystalline cellulose, calcium carbonate, croscarmellose sodium, hypromellose and magnesium stearate of the sertraline hydrochloride of the prescription quantity and the prescription quantity are mixed in a blender for 10min to obtain Intermediates after total blending;

[0038] (2) The intermediate after the total mixing is pressed into tablets according to the weight of the theoretical tablet to obtain plain tablets;

[0039] (3) methacrylic acid copolymer, triethyl citrate, Tween 80 and talcum powder of recipe quantity are dissolved in 80% ethanol, the coating liquid of preparation concentration 8%; And coating liquid is added coating machine Inside;

[0040] (4) Put the sertraline hydrochloride tablets into the coating pan, preheat, and when the tablet bed temperature reaches 40°C, spray the slurry, control the tablet bed temperature to about 40°C, and the coating liquid flow rate to be 40g / min. The surface ...

Embodiment 3

[0042]

[0043] Its preparation method is

[0044] (1) Sertraline hydrochloride of prescription quantity and microcrystalline cellulose of prescription quantity, microcrystalline cellulose, croscarmellose sodium, hypromellose and magnesium stearate are mixed in mixer for 10min , to obtain the intermediate after the total blending;

[0045] (2) The intermediate after the total mixing is pressed into tablets according to the weight of the theoretical tablet to obtain plain tablets;

[0046] (3) methacrylic acid copolymer, triethyl citrate, Tween 80 and talcum powder of recipe quantity are dissolved in 80% ethanol, the coating liquid of preparation concentration 8%; And coating liquid is added coating machine Inside;

[0047] (4) Put the sertraline hydrochloride tablets into the coating pan, preheat, and when the tablet bed temperature reaches 40°C, spray the slurry, control the tablet bed temperature to about 40°C, and the coating liquid flow rate to be 40g / min. The surfac...

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Abstract

The invention discloses an enteric coated tablet containing sertraline hydrochloride and a preparation method thereof. The tablet is prepared from a naked tablet and an enteric coating membrane, wherein the naked tablet is prepared by adding a filling agent, a disintegrating agent, an adhesive and a lubricant into the sertraline hydrochloride through direct tabletting. The weight gain of the enteric coating membrane is 2-4%, so that the enteric coating membrane is disabled to dissolve and release in a stomach to generate untoward effect, and can be quickly dissolved and released in duodenums,and therefore, drug therapeutic effect is guaranteed. Besides, in order to ensure the stability of the sertraline hydrochloride tablet in intestinal tract, the content of methacrylic acid copolymer inthe enteric coating membrane is increased, and the content of tween 80 is further reduced. The enteric coated tablet disclosed by the invention has the characteristics of good dissolution rate, highstability, good invivo absorption and small individual difference, and is lower in side effect. The enteric coated tablet also has the advantages of simple preparation process and suitability for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an enteric-coated tablet containing sertraline hydrochloride and a preparation method thereof. Background technique [0002] Sertraline hydrochloride tablets are mainly used to treat symptoms related to depression, including depression accompanied by anxiety, with or without a history of mania. Its main component is sertraline hydrochloride, and its chemical name is: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl- 1-naphthyridinamine hydrochloride, its structural formula is as follows: [0003] [0004] Sertraline Hydrochloride Tablets (trade name: Zoloft) was developed by Pfizer and first launched in the UK in 1990. In December 1991, Zoloft was approved by the FDA. It was launched in the United States in 1992 and has been marketed in 96 countries and regions around the world. It still occupies an irreplaceable position in the ant...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/137A61K47/38A61K47/36A61K47/32A61P25/24
CPCA61K9/2054A61K9/2059A61K9/284A61K31/137A61P25/24
Inventor 潘裕生吴肖蒙俞悦王海翔洪华斌
Owner 乐普制药科技有限公司
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