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Meclofenoxate hydrochloride stomach-floating sustained release capsule and preparing method thereof

A technology of meclofenoxate hydrochloride and sustained-release capsules, which is applied in the field of medicine, can solve the problems of not being able to satisfy various patients and effectively solve the stability problems of meclofenoxate hydrochloride, and achieve convenient medication, complete release, and enhanced stability sexual effect

Inactive Publication Date: 2008-07-30
SHANGHAI PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But these dosage forms can not effectively solve the stability problem of meclofenoxate hydrochloride, can not meet the needs of various patients

Method used

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  • Meclofenoxate hydrochloride stomach-floating sustained release capsule and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1) Prescription composition of ball core (1000 capsules)

[0035] Component name Weight

[0036] Meclofenoxate hydrochloride 50.0g

[0037] Microcrystalline Cellulose 40.0g

[0038] Cetyl Alcohol 300.0g

[0039] Cross-linked polyvinylpyrrolidone 10.0g

[0040] Specification: 400mg / capsule

[0041] 2) Ball core preparation process

[0042] The raw material drug is properly dried and pulverized, and passed through a 100-mesh sieve; another microcrystalline cellulose, cetyl alcohol, and cross-linked polyvinylpyrrolidone are respectively passed through a 80-mesh sieve; Appropriate amount of aqueous solution, made of soft materials, prepared pellets by extrusion-spheronization method, dried at 40°C for 3 hours, granulated with 20-28 mesh sieves, and set aside.

[0043] 3) Prescription of coating solution

[0044] Ethyl cellulose (20cp) 20g

[0045] Macrogol 400 1g

[0046] Talc powder 2g

[0047] 80% ethanol 1000mL

[0048] 4) Coating process

[0049] The conventio...

example 1

[0051] Example 1 Preparation of Gastric Float Sustained-release Capsules 5-minute Float Rate and 8-Hour Float Rate Investigation

[0052]

Embodiment 2

[0054] 1) Prescription composition of ball core (1000 capsules)

[0055] Component name Weight

[0056] Meclofenoxate hydrochloride 50.0g

[0057] Starch 20.0g

[0058] Microcrystalline Cellulose 20.0g

[0059] Octadecanol 300.0g

[0060] Cross-linked polyvinylpyrrolidone 10.0g

[0061] Specification: 400mg / capsule

[0062] 2) Ball core preparation process

[0063] Properly dry the raw material drug, crush it, and pass it through a 100-mesh sieve; separately take microcrystalline cellulose, starch, stearyl alcohol, and cross-linked polyvinylpyrrolidone and pass it through a 80-mesh sieve; weigh and mix evenly according to the prescription amount, add pH2- An appropriate amount of aqueous solution of -5 is used to make soft materials, and pellets are prepared by extrusion-spheronization method, dried at 40°C for 3 hours, granulated with a 20-28 mesh sieve, and set aside.

[0064] 3) Prescription of coating solution

[0065] Ethyl cellulose (20cp) 20g

[0066] Macrogol ...

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Abstract

The invention discloses a meclofenoxate hydrochloride intra-gastric floating sustained release capsule. The invention adopts the intra-gastric floating sustained release technique to prevent the bad effect to the stability of the medicine in capsules caused by the elevation of the PH value in gastrointestinal tract, avoid intestinal juice in human body from retrograding the meclofenoxate hydrochloride in capsules, which ensures that the medicine can release steadily, slowly and completely. The capsule of the invention should be taken twice every day and can float continuously in stomach for more than 8 hours; the medicine can be released for 12 hours continuously and the release rate at last reaches to over 90 percent, thereby enhancing the stability of the medicine, prolonging the curing effect, greatly being convenient for patients to take medicine. The invention also provides the preparation method.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to meclofenoxate hydrochloride gastric floating sustained-release capsules for oral administration and a preparation method thereof. Background technique [0002] Meclofenoxate Hydrochloride was artificially synthesized by Professor Thuillier of the French National Center for Scientific Research in 1957. Its chemical name is 2-(dimethylamino)ethyl p-chlorophenoxyacetate hydrochloride. China has been producing the drug since the 1960s (the trade name used to be cloxatexal). [0003] Clinically, meclofenoxate hydrochloride is a central stimulant drug that has been used for many years. It is mainly used for the treatment of traumatic brain injury coma, neonatal hypoxia, and mental confusion. Children's enuresis, etc. (so it is also called enuresis D). With the continuous deepening of research, it was found that chlorpheniramine is an activator of brain cell metabolism fu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/222A61K9/52A61K47/10A61K47/12A61K47/14A61K47/32A61K47/36A61K47/38A61K47/44A61P25/26A61P25/28
Inventor 胡海洋陈大为茅关兴
Owner SHANGHAI PHARMA IND
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