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Olopatadine hydrochloride dispersible tablets, preparation method thereof and quality control method thereof

A kind of technology of olopatadine hydrochloride and detection method, applied in the field of medicine

Inactive Publication Date: 2012-07-25
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Olopatadine hydrochloride is only listed as eye drops in China, which is used to treat allergic conjunctivitis. In the existing literature, only patent CN101065122A "method for delivering nasal spray" and patent CN101217937A "containing olopatadine hydrochloride Transdermal absorption ophthalmic preparation", patent CN1211125C "Olopatadine hydrochloride preparation for topical administration", but there is no oral preparation on the market yet

Method used

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  • Olopatadine hydrochloride dispersible tablets, preparation method thereof and quality control method thereof
  • Olopatadine hydrochloride dispersible tablets, preparation method thereof and quality control method thereof
  • Olopatadine hydrochloride dispersible tablets, preparation method thereof and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0153] Olopatadine Hydrochloride 5g

[0154] Lactose 45g

[0155] Microcrystalline Cellulose 82g

[0156] Sodium carboxymethyl starch 7g

[0157] 2% low viscosity hypromellose 40g

[0158] Magnesium Stearate 1g

[0159] (1) Pass olopatadine hydrochloride, lactose, microcrystalline cellulose, and sodium carboxymethyl starch through an 80-mesh sieve respectively, and set aside.

[0160] (2) Prepare 2% low-viscosity hydroxypropyl methylcellulose solution for later use.

[0161] (3) After taking the prescribed amount of olopatadine hydrochloride and lactose and mixing evenly, then mixing evenly with sodium carboxymethyl starch and microcrystalline cellulose, making the soft material with the above-mentioned 2% low-viscosity hydroxypropyl methylcellulose solution, Moisture granules. Wet granules are dried below 65°C. After granulation, add magnesium stearate and mix well.

[0162] (4) Determining the main drug content of the dry granules, determining the tablet weight, and ...

Embodiment 2

[0165] Olopatadine Hydrochloride 5g

[0166] Lactose 40g

[0167] Microcrystalline Cellulose 75g

[0168] Sodium carboxymethyl starch 10g

[0169] 2% low viscosity hypromellose 50g

[0170] Magnesium Stearate 1g

[0171] (1) Pass olopatadine hydrochloride, lactose, microcrystalline cellulose, and sodium carboxymethyl starch through a 120-mesh sieve respectively, and set aside.

[0172] (2) Prepare 2% low-viscosity hydroxypropyl methylcellulose solution for later use.

[0173] (3) After taking the prescribed amount of olopatadine hydrochloride and lactose and mixing evenly, then mixing evenly with sodium carboxymethyl starch and microcrystalline cellulose, making the soft material with the above-mentioned 2% low-viscosity hydroxypropyl methylcellulose solution, Moisture granules. Wet granules are dried below 80°C. After granulation, add magnesium stearate and mix well.

[0174] (4) Determining the main drug content of the dry granules, determining the tablet weight, and...

Embodiment 3

[0177] Olopatadine Hydrochloride 5g

[0178] Lactose 40g

[0179] Microcrystalline Cellulose 85g

[0180] Sodium carboxymethyl starch 5g

[0181] 2% low viscosity hypromellose 30g

[0182] Magnesium Stearate 2g

[0183] (1) Pass olopatadine hydrochloride, lactose, microcrystalline cellulose, and sodium carboxymethyl starch through a 100-mesh sieve respectively, and set aside.

[0184] (2) Prepare 2% low-viscosity hydroxypropyl methylcellulose solution for later use.

[0185] (3) After taking the prescribed amount of olopatadine hydrochloride and lactose and mixing evenly, then mixing evenly with sodium carboxymethyl starch and microcrystalline cellulose, making the soft material with the above-mentioned 2% low-viscosity hydroxypropyl methylcellulose solution, Moisture granules. Wet granules are dried below 65°C. After granulation, add magnesium stearate and mix well.

[0186] (4) Determining the main drug content of the dry granules, determining the tablet weight, and ...

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Abstract

The invention discloses olopatadine hydrochloride dispersible tablets, a preparation method thereof and a quality control method thereof. The olopatadine hydrochloride dispersible tablets contain olopatadine hydrochloride serving as a main medicament and a disintegrating agent, a filler, a binding agent and a lubricating agent which serve as auxiliary materials. A wet-method is adopted for granulation and tabletting, and an internal disintegrating agent addition method is adopted. The olopatadine hydrochloride dispersible tablets have the advantages of excellent dispersion state, short disintegrating time, quick medicament digestion, convenient administration, low production cost, no special equipment, convenient and stable carrying and transport and the like.

Description

technical field [0001] The invention relates to olopatadine hydrochloride dispersible tablets, a preparation method and a quality control method thereof, and belongs to the technical field of medicine. Background technique [0002] There are three types of antiallergic drugs commonly used clinically. 1. Antihistamines: Histamine is a sensitizing substance released during an allergic reaction. Histamine can bind to histamine type I receptors to produce a series of allergic reactions, such as binding to histamine type II receptors can cause increased gastric acid secretion. Antihistamines are mainly histamine type I receptor antagonists, they can compete with histamine for histamine type I receptors on sensitized cells, so that histamine cannot bind to it and produce allergic reactions. 2. Allergic reaction mediator release agent: This type of drug can stabilize the sensitized cell membrane and prevent the release of various allergic reaction mediators such as histamine. 3. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/335A61K47/38A61P37/08G01N21/25G01N30/02G01N30/36
Inventor 张建立曹相林陈婧董世杰魏墨玺
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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