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Sustained-release capsule containing propiverine hydrochloride and preparation method of sustained-release capsule

A technology of propiverine hydrochloride and sustained-release capsules, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, urinary system diseases, etc. Small, high bioavailability, simple process effect

Inactive Publication Date: 2012-07-18
广州科的信医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the propiverine hydrochloride preparations on the domestic market are only ordinary tablets, and no sustained-release preparations have been produced and registered for the time being. The development of once-a-day, 24-hour-release propiverine hydrochloride sustained-release preparations has good clinical application advantages

Method used

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  • Sustained-release capsule containing propiverine hydrochloride and preparation method of sustained-release capsule
  • Sustained-release capsule containing propiverine hydrochloride and preparation method of sustained-release capsule
  • Sustained-release capsule containing propiverine hydrochloride and preparation method of sustained-release capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] 1. Preparation of pill-containing core:

[0034]

[0035] Preparation process: Propiverine hydrochloride, microcrystalline cellulose, and lactose are mixed uniformly in equal increments, purified water is used to make soft material, and pellets are extruded and spheronized. The sieve particle size is 0.8mm, 60 Dry in an oven at ℃, sieving, and select 20-40 mesh-containing pellet cores for coating.

[0036] 2. Package slow release layer:

[0037]

[0038] The prescription amount of Surisi was added to purified water to fully disperse it, stirred for 45 minutes, put the pill-containing core in a fluidized bed, adjusted various process parameters to ensure the fluidized state, and the coating weight increased to 11%.

[0039] The process parameters of the fluidized bed: inlet air volume: 20-30HZ, inlet air temperature: 45-55°C, material temperature: 40-45°C, atomization pressure: 1.0bar, spraying speed: 2~4g / min.

[0040] 3. Curing: Curing in an oven at 50°C for 12 hours.

[0041] 4...

Embodiment 2

[0045] 1. Preparation of pill-containing core:

[0046]

[0047] Preparation process: Propiverine hydrochloride and lactose, microcrystalline cellulose, and anhydrous citric acid are mixed uniformly in equal increments, purified water is used to make soft material, and pellets are extruded and spheronized, and the particle size of the sieve plate It is 0.8mm, dried in an oven at 60°C, sieved, and selected 20-40 mesh-containing pellet cores for coating.

[0048] 2. Package slow release layer:

[0049]

[0050] Add the prescribed amount of talcum powder to purified water and stir for 45 minutes, add Eudragit NE30D water dispersion to make it fully dispersed, continue to stir for 45 minutes, and set aside. The pill core containing medicine is placed in a fluidized bed, and various process parameters are adjusted to ensure a fluidized state, and the coating weight increases to 3.5%.

[0051] The process parameters of the fluidized bed: inlet air volume: 20-30HZ, inlet air temperature: 35...

Embodiment 3

[0057] 1. Preparation of pill-containing core:

[0058]

[0059] Preparation process: Dissolve propiverine hydrochloride, PVP-K30 and citric acid in purified water, stir and use to dissolve completely to prepare a drug-containing solution. The microcrystalline cellulose blank pill core is placed in a fluidized bed, the above-mentioned drug-containing solution is sprayed on the surface of the blank pill core, and the pill-containing core is prepared by the drug application method, dried, and screened to take 20-30 mesh pill-containing cores, and then coated use.

[0060] 2. Package slow release layer:

[0061]

[0062] Add the prescription amount of talcum powder to purified water and stir for 45 minutes, add triethyl citrate, Eudragit RS30D and RL30D water dispersion to make it fully dispersed, continue to stir for 45 minutes, and set aside. Put the drug-containing pellet core in a fluidized bed, adjust various process parameters to ensure the fluidized state, and the coating weigh...

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Abstract

The invention discloses a sustained-release capsule containing propiverine hydrochloride and a preparation method of the sustained-release capsule. The sustained-release capsule comprises sustained-release micropills and an empty capsule, wherein, the sustained-release micropills comprise pill cores containing drugs accounting for 75 to 97 percent and sustained-release coating layers accounting for 3 to 25 percent by weight percentage. The sustained-release capsule containing propiverine hydrochloride comprises hundreds of the sustained-release micropills with uniform particle sizes, and preparation errors or preparation defects of individual micropills cannot influence the drug release behavior of the whole preparation seriously, so that the sustained-release capsule is safer than a sustained-release tablet, the irritant activity to gastrointestinal tracts is smaller, plasma concentration is smoother, the bioavailability is higher, and the sustained-release capsule can continuously release the drugs for 24 hours if being taken for one time per day so as to treat overactive bladder. The preparation method of the sustained-release capsule prepares the pill cores containing the drugs in an extrusion and spheronization method or a drug added manner, adopts a fluidized bed to coat the sustained-release coating layers, achieves simple technology, and is easy to achieve industrialized mass production.

Description

Technical field [0001] The present invention relates to the technical field of propiverine hydrochloride sustained-release preparations, in particular to a propiverine hydrochloride sustained-release capsule and a preparation method thereof. It belongs to a sustained-release preparation of antispasmodic drugs. Background technique [0002] Overactive Bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequent urination and nocturia, with or without urge incontinence; urodynamics can be compelling Urinary muscle overactivity (Detrusor instability, or detrusor overactivity) can also be other forms of urethra-bladder dysfunction. OAB is defined by the International Continence Association (ICS) as an unconscious contraction of the detrusor muscle without a clear cause. It does not include symptoms caused by acute urinary tract infection or other forms of bladder and urethral local lesions. The symptoms of OAB are caused by the involuntary contraction...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/445A61K47/32A61K47/36A61K47/38A61P13/06A61P13/10
Inventor 黎炜烘
Owner 广州科的信医药技术有限公司
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