A kind of fluoxetine hydrochloride capsule and preparation method thereof

A technology of fluoxetine hydrochloride capsules and fluoxetine hydrochloride, which is applied in the directions of capsule delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc., can solve problems such as affecting clinical compliance and the like

Active Publication Date: 2022-07-22
SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Capsules are different from tablets. Capsules have no flavoring agents and are not affected by stress factors. They are rapidly dispersed, dissolved and absorbed in the gastrointestinal tract. The local concentration in the stomach is too high, which can easily stimulate the gastric mucosa and cause nausea, vomiting and other adverse effects. response, which in turn affects clinical compliance

Method used

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  • A kind of fluoxetine hydrochloride capsule and preparation method thereof
  • A kind of fluoxetine hydrochloride capsule and preparation method thereof
  • A kind of fluoxetine hydrochloride capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 2

[0061] The preparation of embodiment 1 simethicone emulsion

[0062] Pick materials according to the types of materials designed in the recipes shown in Table 2; for the simethicone emulsion, design and weigh the auxiliary materials according to recipes 1 to 3, operate according to the process control parameters in Table 3, and heat the weighed water, and the temperature is not When the temperature exceeds 80 °C, add polyoxy 40 stearate, stir and disperse with a high-shear dispersing emulsifier, and then add dimethicone, and adjust the stirring speed of the high-shear dispersing emulsifier to 5000 rpm to 20,000 rpm to obtain a simethicone emulsion. , it does not delaminate after standing for 24h.

[0063] The prescription screening of table 2 pregelatinized starch lubricant

[0064]

[0065] Table 3 Process Screening of Pregelatinized Starch Lubricants

[0066] Process control parameters Existing prescription prescription 1 prescription 2 prescription 3 ...

Embodiment 2

[0067] The preparation of embodiment 2 fluoxetine hydrochloride capsule

[0068] Pick materials according to the types of materials designed in the recipe shown in Table 4, and operate according to the process control parameters in Table 5. The fluoxetine hydrochloride is pulverized, and the particle size distribution D90 is controlled at 20 μm to 100 μm; the pregelatinized starch and silica are passed through a 60-mesh sieve. Weigh the raw materials and excipients according to the design amount of prescription 1-3. Add the pregelatinized starch to the wet granulator, set the stirring speed of the wet granulator to 70 rpm to 100 rpm and the cutting speed to 1200 rpm to 1800 rpm, then start the wet granulator, and use the spray technique to add simethicone emulsion and water for granulation. Then use 6.0mm×6.0mm square-hole screen for wet granulation. After unloading, it is dried in a fluidized bed to measure the moisture content of the material. When the moisture content is l...

Embodiment 3

[0080] Example 3 Comparison of in vitro dissolution curves of fluoxetine hydrochloride capsules (A, B, C) prepared by the present invention, existing product (X) and reference preparation (R)

[0081] Get each 12 capsules of fluoxetine hydrochloride capsules (A, B, C), existing product (X) and reference preparation (R) prepared in Example 2, and detect its hydrochloric acid solution at pH1.0, pH4 according to the following method In vitro dissolution profiles of .5 acetate buffer, pH 6.8 phosphate buffer and water. The detection method is shown in Table 7.

[0082] The method of table 7 fluoxetine hydrochloride capsules in 4 different dissolution media

[0083] Dissolution medium method Rotating speed Surfactant pH1.0 hydrochloric acid solution paddle method 50 rpm none pH4.5 acetate buffer solution paddle method 50 rpm none pH6.8 Phosphate buffer solution paddle method 50 rpm none water paddle method 50 rpm none ...

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Abstract

The invention discloses a fluoxetine hydrochloride capsule and a preparation method thereof, as well as its application in the consistency evaluation of its quality and curative effect. In the present invention, the fluoxetine hydrochloride is pulverized, the auxiliary materials are sieved, the simethicone emulsion is sprayed onto the surface of the pregelatinized starch, and the pregelatinized starch blank granules are obtained by granulation. The content, content uniformity, related substances, dissolution rate, etc. of the obtained fluoxetine hydrochloride capsules are the same as those of the reference preparation (fluoxetine hydrochloride capsules, 100 Worry solution / Prozac, 20mg, license holder LILLY FRANCE); multiple dissolution curves in vitro are similar to the reference preparation; bioequivalent to the reference preparation, with better safety and compliance; the product of the present invention does not increase the packaging cost Stability is good for 24 months under conditions.

Description

technical field [0001] The invention relates to a fluoxetine hydrochloride capsule and a preparation method thereof, as well as its application in the field of consistency evaluation of generic drugs. Background technique [0002] The traditional antidepressants are cyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs), including amitriptyline, clomipramine and so on. Due to the many adverse reactions of traditional antidepressants, they are less used and gradually replaced by new antidepressants. As a selective 5-HT reuptake inhibitor, fluoxetine is a new type of antidepressant widely used in clinical practice. Absorption, increases the level of 5-HT that can bind to postsynaptic receptors in the synaptic cleft, thereby acting as an antidepressant. Fluoxetine hydrochloride is a Class I drug of the BCS classification. [0003] According to the FDA database, the dosage forms involved in fluoxetine hydrochloride include tablets, dispersible tablets, capsule...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/137A61K47/36A61K47/34A61K47/04A61P25/24
CPCA61K9/1611A61K9/1652A61K9/1641A61K31/137A61P25/24
Inventor 李福高赵志良虞英民李俊峰贾佩骞谢齐昂刘东华宣燕红
Owner SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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