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Cetirizine hydrochloride orally-taken drops and preparation method thereof

A technology of cetirizine hydrochloride and oral drops, applied in the field of medicine, can solve the problems of poor compliance, affecting the therapeutic effect of cetirizine hydrochloride, long disintegration time of tablets or capsules, etc.

Inactive Publication Date: 2020-05-05
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Cetirizine hydrochloride is odorless, bitter, hygroscopic, and easily soluble in water, but its tablet or capsule disintegrates for a long time, has low dissolution rate and dissolution rate, poor absorption, and low bioavailability. And patients with dysphagia are inconvenient to take and have poor compliance, which will affect the therapeutic effect of cetirizine hydrochloride.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] name 500 ml volume (g) Cetirizine Hydrochloride 0.25 Methylparaben 0.15 sucrose 300.0 citric acid 1.50 sodium citrate 10.00 Propylene Glycol 25.00 Peach Essence 0.50 Purified water to volume Add to 500ml

[0015] Preparation Process:

[0016] (1) Weigh a certain amount of purified water and preheat it in a 50°C water bath, add the prescribed amount of cetirizine hydrochloride raw material, sucrose, sodium citrate, etc., stir to dissolve, and cool to room temperature to obtain a solution 1;

[0017] (2) Preheat the prescribed amount of propylene glycol in a 50°C water bath, add the prescribed amount of methyl paraben, stir to dissolve, and cool to room temperature to obtain solution 2;

[0018] (3) After mixing solution 1 and solution 2 evenly, add citric acid and peach essence, and dilute purified water to 500ml to obtain solution 3;

[0019] (4) Filter the solution 3, fill it in a drop bottle after passi...

Embodiment 2

[0021] name 500 ml volume (g) Cetirizine Hydrochloride 0.25 sodium benzoate 0.15 aspartame 150.0 citric acid 1.50 sodium citrate 10.00 vanilla essence 0.50 Purified water to volume Add to 500ml

[0022] Preparation Process:

[0023] (1) Weigh a certain amount of purified water and preheat it in a 50°C water bath, add the prescribed amount of cetirizine hydrochloride API, aspartame, sodium citrate, etc., stir to dissolve, cool to room temperature, To obtain solution 1;

[0024] (2) Preheat a certain amount of purified water in a 50°C water bath, add the prescribed amount of sodium benzoate, stir to dissolve, and cool to room temperature to obtain solution 2;

[0025] (3) Mix solution 1 and solution 2 evenly, add citric acid and vanilla essence, and dilute to 500ml with purified water to obtain solution 3;

[0026] (4) Filter the solution 3, fill it in a drop bottle after passing the quality inspection, the volume of ea...

Embodiment 3

[0028] name 500 ml volume (g) Cetirizine Hydrochloride 0.25 Ethylparaben 0.15 sucrose 300.0 glacial acetic acid 1.50 Sodium acetate 10.00 Propylene Glycol 25.00 strawberry flavor 0.50 Purified water to volume Add to 500ml

[0029] Preparation Process:

[0030] (1) Weigh a certain amount of purified water and preheat it in a 50°C water bath, add the prescribed amount of cetirizine hydrochloride raw material, sucrose, sodium acetate, etc., stir to dissolve, and cool to room temperature to obtain solution 1;

[0031] (2) Preheat the prescribed amount of propylene glycol in a 50°C water bath, add the prescribed amount of ethylparaben, stir to dissolve, and cool to room temperature to obtain solution 2;

[0032] (3) After mixing solution 1 and solution 2 evenly, add glacial acetic acid and strawberry essence, and dilute purified water to 500ml to obtain solution 3;

[0033] (4) Filter the solution 3, fill it in a drop...

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PUM

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Abstract

The invention relates to a preparation method of cetirizine hydrochloride orally-taken drops, and belongs to the technical field of medicine and pharmacy. The cetirizine hydrochloride orally-taken drops are prepared from cetirizine hydrochloride bulk drug, a solvent, a correctant, a preservative, a pH-regulating agent and the like, and through quantified droppers, medicinal liquids are directly dripped into the oral cavity. The cetirizine hydrochloride orally-taken drops are an solution type preparation and have the following characteristics that 1, the quantified dropper is adopted and is screwed with a proportional valve, so that the medicine administration dosage is accurate, scientific and reasonable, and the shortcoming of administrating medicines by experience clinically is avoided;2, the drops can enable medicinal liquid to directly drip into the oral cavity of a patient, so that the medicine administration is convenient, and the cetirizine hydrochloride orally-taken drops areparticularly suitable for old people and patients suffering from dysphagia to use; 3, medicines are distributed in the state of molecules in liquid, so that after the medicine administration, the cetirizine hydrochloride orally-taken drops are rapid to absorb and take effect quickly; and 4, the cetirizine hydrochloride orally-taken drops are good in mouth feel, easy to accept by patients and goodin compliance.

Description

technical field [0001] The invention relates to a cetirizine hydrochloride oral drop and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] The World Health Organization has listed allergic diseases as one of the three major diseases that need to be researched and prevented in the 21st century. The incidence of allergic diseases in my country has reached about 38%, the incidence of coastal cities is higher than that of inland areas, and the incidence of heavy industrial cities is higher than that of light industrial cities. According to statistics, the current retail market capacity of anti-allergic drugs in my country is about 1.2 billion yuan, and the market potential is huge. Antihistamines are widely used clinically, mainly for the desensitization treatment of allergic diseases of the human immune system. It plays an important role in the treatment of urticaria and allergic dermatitis, allergic rhinitis and allergi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/495A61P37/08A61P11/02A61P11/06A61P17/00
CPCA61K9/0053A61K9/08A61K31/495A61K47/26A61P11/02A61P11/06A61P17/00A61P37/08
Inventor 谭丽鹤王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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