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Gastrodin double-pulse drug-release preparation

A technology of gastrodin and sub-pulse, which is applied in the direction of medical formula, drug combination, drug delivery, etc., can solve the problems of easy early awakening, etc., and achieve the effect of solving easy early awakening, expanding the scope of application, and ensuring sleep time and quality

Active Publication Date: 2013-09-18
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The gastrodin twice-pulse drug release preparation provided by the present invention expands the application range of gastrodin, a water-soluble drug with a short half-life, in the field of insomnia treatment, and can realize timed pulse release at the two most critical time points in the sleep process. It can also solve the problems of insomnia patients who have trouble falling asleep and wake up early, and ensure their sleep time and quality

Method used

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  • Gastrodin double-pulse drug-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1 Preparation of gastrodin twice pulse release formulation

[0042] Pill core prescription:

[0043] Gastrodin 50g

[0044] 150g lactose

[0045] Immediate-release pellet coating liquid prescription:

[0046] Opadry 60g

[0047] Water 300ml

[0048] The prescription of delayed release pellet coating solution:

[0049] Swelling layer:

[0050] Croscarmellose Sodium 80g

[0051] Hypromellose 20g

[0052] Water 8000ml

[0053] Time delay layer:

[0054] Su Lisi 150ml

[0055] Water 100ml

[0056] Production method: Take gastrodin and fine lactose powder (pass 80 mesh sieve) and mix, add appropriate amount of water to make soft material, squeeze it into thin strips through extruder sieve plate (aperture 0.8mm), put in spheronizer, rotating speed is 1000rpm, spheronization time 4min, make the pellets completely rounded, dried at 60℃, sizing with a 20-mesh sieve to obtain pellet cores. The drug-loaded pill core is coated with a fluidized bed, the immediate release pellets are coated wi...

Embodiment 2

[0057] Example 2 Preparation of gastrodin twice pulse release formulation

[0058] Pill core prescription:

[0059] Gastrodin 50g

[0060] Microcrystalline cellulose 100g

[0061] Immediate-release pellet coating liquid prescription:

[0062] Hypromellose 50g

[0063] Dibutyl sebacate 15g

[0064] Ethanol 800ml

[0065] The prescription of delayed release pellet coating solution:

[0066] Swelling layer:

[0067] Low-substituted hydroxypropyl cellulose 30g

[0068] Hypromellose 30g

[0069] 5000ml water

[0070] Time delay layer:

[0071] Ethyl cellulose 20g

[0072] Dibutyl sebacate 5g

[0073] Ethanol 400ml

[0074] Production method: Take gastrodin and microcrystalline cellulose powder (pass 80 mesh sieve) and mix well, add appropriate amount of water to make soft material, squeeze it into thin strips through extruder sieve plate (aperture 0.8mm), and place in spheronizer , Adjust the speed and spheronization time to make the granules completely round, dry at 60℃, and use an 18-mesh sieve to ge...

Embodiment 3

[0075] Example 3 Preparation of Gastrodin Twice Pulse Release Preparation

[0076] Pill core prescription:

[0077] Gastrodin 50g

[0078] 150g lactose

[0079] Microcrystalline cellulose 100g

[0080] Immediate-release pellet coating liquid prescription:

[0081] Hypromellose 20g

[0082] Diethyl phthalate 3g

[0083] Ethanol 400ml

[0084] The prescription of delayed release pellet coating solution:

[0085] Swelling layer:

[0086] Sodium starch glycolate 100g

[0087] Hypromellose 20g

[0088] Water 9000ml

[0089] Time delay layer:

[0090] Ethyl cellulose 50g

[0091] Diethyl phthalate 5g

[0092] Ethanol 800ml

[0093] Preparation method: take gastrodin, lactose and fine microcrystalline cellulose powder (pass 80 mesh sieve) and mix it, add appropriate amount of water to make soft material, squeeze it into thin strips through extruder sieve plate (aperture 0.6mm), and set spheronization Inside the machine, adjust the speed and spheronization time to make the granules completely round, dry at...

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Abstract

The invention relates to the field of pharmaceutical preparation, and in particular relates to a gastrodin double-pulse drug-release preparation. The preparation consists of quick release pellets and slow-release pellets, wherein the quick release pellets consist of gastrodin quick release pellet cores and quick release layers, and the slow-release pellets consist of gastrodin slow-release pellet cores, swelling layers and time-lag layers. By utilizing the gastrodin double-pulse drug-release preparation provided by the invention, the application range of water-soluble medicinal gastrodin with short half-life period is widened in the insomnia treatment field, and the pulse drug release of the double-pulse drug-release preparation can be realized in two key time points at fixed times in an insomnia process; moreover, problems of difficulty in sleeping and early awakening of insomnia patients can be solved, and the sleeping time and quality are ensured.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a two-pulse drug release preparation of gastrodin. Background technique [0002] With the acceleration of social life in today's society and the increase of mental stress, insomnia has become one of the common pains of people, and it is one of the most common clinical symptoms besides pain. Long-term lack of sleep can lead to sleepiness during the day, decreased concentration, affect physical and mental health and quality of life, and even depression in severe cases. According to the World Health Organization, nearly a quarter of people worldwide suffer from insomnia. According to the survey data of the Chinese Medical Association, the prevalence of sleep disorders in my country is 42.7%, and about 300 million middle-aged people suffer from sleep disorders. [0003] There are three main clinical manifestations of insomnia: first, difficulty falling asleep, also called "start...

Claims

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Application Information

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IPC IPC(8): A61K9/62A61K31/7034A61K47/38A61P25/20
Inventor 蔡铮刘中秋杨兆祥张国丽张琪黄娟龚耘罗辉唐琪晶
Owner KPC PHARM INC
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