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Formula and preparation method for ranitidine hydrochloride slow release suspension

A technology of ranitidine hydrochloride and sustained-release suspension, which is applied in the field of medicine, can solve the problems of poor patient compliance, inconvenient administration, and odor, and achieve stable blood drug concentration, high bioavailability, and large distribution area. big effect

Inactive Publication Date: 2019-10-15
WUYI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in recent years, many literature reports that ranitidine hydrochloride is off-white to light yellow crystalline powder, has a peculiar smell, is slightly bitter and astringent, easily increases the difficulty of oral administration, and poor patient compliance, thus affecting the efficacy of the drug. ; In addition, although ranitidine hydrochloride has the characteristics of strong drug effect and rapid action, the peak time of blood drug concentration is short (oral, 30-90min to peak)
Eliminates quickly in the body, and may even cause side effects such as dizziness, nausea, facial heat, rash, and drowsiness. Now there are tablets, capsules and other dosage forms on the market, but these common preparations are generally 150mg each time, and the daily dosage is 2 -3 times, it needs to be taken more times a day, which is likely to cause large fluctuations in blood concentration, and sometimes it needs to be administered at night, which is inconvenient to administer

Method used

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  • Formula and preparation method for ranitidine hydrochloride slow release suspension
  • Formula and preparation method for ranitidine hydrochloride slow release suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The preparation of the drug-loaded resin containing ranitidine hydrochloride by dynamic method comprises the following steps:

[0031] S1: Weigh 500 mg of cation exchange resin, pack it into a column with a wet method, put it into a dynamic exchange column with a diameter of 2 cm, spread it on the bottom of the dynamic exchange column, and remove the air in it;

[0032] S2: 5mg·mL at room temperature -1 The ranitidine hydrochloride aqueous solution is poured into the exchange column from top to bottom;

[0033] S3: Adjust the lower hole plug to make it flow at 2mL·min -1 Keep the solution temperature at 25.0°C±0.5°C under constant flow rate;

[0034] S4: Take samples every 20 minutes and perform UV measurement, when the drug concentration no longer changes with time, it will reach equilibrium;

[0035] S5: After the drug loading is completed, the wet resin is washed three times with deionized water to remove the free drug on its surface;

[0036] S6: put in an oven ...

Embodiment 2

[0052] The preparation of the drug-loaded resin containing ranitidine hydrochloride by dynamic method comprises the following steps:

[0053] S1: Weigh 600mg of cation exchange resin, pack it into a column with a wet method, put it into a dynamic exchange column with a diameter of 2.5cm, spread it on the bottom of the dynamic exchange column, and remove the air in it;

[0054] S2: 3 mg·mL at room temperature -1 The ranitidine hydrochloride aqueous solution is poured into the exchange column from top to bottom;

[0055] S3: Adjust the lower hole plug to make it flow at 1mL min -1 Keep the solution temperature at 25.0°C±0.5°C under constant flow rate;

[0056] S4: Take samples every 20 minutes and perform UV measurement, when the drug concentration no longer changes with time, it will reach equilibrium;

[0057] S5: After the drug loading is completed, the wet resin is washed three times with deionized water to remove the free drug on its surface;

[0058]S6: put in an oven ...

Embodiment 3

[0074] Comparison of the drug loading capacity of ranitidine hydrochloride drug-loaded resin by dynamic method and static method:

[0075] (1) Static preparation method:

[0076] Take 500mg blank resin and add to 5mg·mL -1 The ranitidine hydrochloride solution was magnetically stirred at room temperature (25°C), sampled at fixed points, and the drug loading (Qt) was plotted against the exchange time t, and the drug utilization rate was calculated.

[0077] (2) Dynamic preparation method:

[0078] Take 500mg of blank resin, wet-pack the column, spread it on the bottom of the exchange column, remove the air in it, and put 5mg·mL at room temperature (25°C) -1 The L ranitidine hydrochloride solution was poured into the exchange column from top to bottom, and its flow rate was adjusted to be 2ml / min. Samples were taken at fixed points, and the drug loading (Qt) was plotted against the exchange time t, and the drug utilization rate was calculated.

[0079] The result is as figur...

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Abstract

The invention relates to the technical field of medicines, and discloses a formula and a preparation method for a ranitidine hydrochloride slow release suspension. The slow release suspension comprises the following ingredients in parts by weight: 20-80% of ranitidine hydrochloride medicine carrying resin micro-capsule, 20-80% of slow release auxiliary material and the balance of other auxiliary materials. Since a dynamic method is adopted to prepare the ranitidine hydrochloride medicine resin, the medicine carrying rate of the medicine resin can be obviously improved. Through reasonable configuration, the ranitidine hydrochloride is prepared into the oral liquid slow release suspension. According to different dosage requirements, the slow release suspension is taken according to dosages,and the slow release suspension has the advantages of large distribution area in gastrointestinal tracts, high adsorption speed, stable blood concentration and high bioavailability, and can reduce irritation to gastrointestinal tracts and the influence on in-vivo behaviors by a gastric emptying rate. Meanwhile, ranitidine and ion exchange resin generate ion exchange, so that a medicine enters a skeleton to cover the bitter taste of the ranitidine hydrochloride.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a formulation of ranitidine hydrochloride sustained-release suspension and a preparation method thereof. Background technique [0002] Ranitidine hydrochloride is a gastric medicine widely used clinically, which can relieve gastric pain, heartburn (heartburn), acid reflux, etc. caused by hyperacidity, and is used for the treatment of duodenal ulcer, gastric ulcer, Fluid esophagitis, Zollinger-Ellison syndrome and other diseases with high gastric acid secretion. It has long-term and strong effects of inhibiting gastric secretion and anti-ulcer, highly selective to H2 receptors and mild side effects (no hepatic drug enzyme inhibition, no teratogenic, carcinogenic effects and no anti-androgen and central inhibition )Etc. However, in recent years, many literature reports that ranitidine hydrochloride is off-white to light yellow crystalline powder, has a peculiar smell, is slightl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/38A61K47/32A61K47/10A61K9/58A61K31/341A61P1/04
CPCA61K9/10A61K9/5026A61K9/5031A61K31/341A61K47/10A61K47/32A61K47/38A61P1/04
Inventor 刘宏飞杜仪
Owner WUYI UNIV
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