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Oral sustained releasing micropill of tuduranine and their preparation method
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A technology for slow-release pellets and sinomenine, which is applied in the directions of pill delivery, sugar-coated pills, and pharmaceutical formulations to achieve good reproducibility.
Inactive Publication Date: 2006-10-11
SHANGHAI INST OF PHARMA IND CO LTD
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Therefore, how to improve some shortcomings of sustained-release tablets is a very realistic problem from the perspective of clinical treatment.
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[0038] (The above is the prescription of the medicine)
[0039] Surelease 70 grams
[0040] water 50g
[0041] (coating prescription)
[0042] use figure 1 The procedure shown for the preparation:
[0043] (1) Prescription of upper medicine is prepared into suspension, and its particle diameter is 10 microns;
[0044] (2) Place the inert ball core in the boiling drier 1, pass hot air from the bottom of the drier 1, make the inert ball core in a fluidized state, and put the suspension in step (1) from the bottom of the drier 1 After spraying through the nozzle 2, the suspension is sprayed on the inert ball core and dried;
[0045] Hot air temperature: 45°C, material temperature: 30°C, atomization pressure: 1.5bar; wind speed: 0.2-2 m / s
[0046] (3) Continue to pass in hot air to keep the inert ball core in ...
[0072] The preparation method is the same as in the examples.
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Abstract
The invention discloses an oral sustained-release pellet of sinomenine or a salt thereof and a preparation method thereof. The sinomenine or its salt of the present invention is composed of an inert ball core loaded with a therapeutically effective amount of active ingredients and pharmaceutical adjuvants and a coating wrapped thereon, and the invention adopts a fluidization process for drug application and coating. The medicine on the core of the ball is carried out in a fluidized state with an aqueous suspension composed of sinomeninehydrochloride micropowder and some fillers. The coating of the slow-release coating layer is preferably made of ethyl celluloseaqueous dispersion in the same fluidized device. conduct. The sinomenine micropills that this technology makes, respectively in water pH1.0 hydrochloric acid, in three kinds of media of aqueous solution and pH6.8 phosphatebuffer solution, adopt Chinese Pharmacopoeia 2000 edition I method, carry out release test, the result shows that micropill releases Both pills last up to 12 hours. The process has the characteristics of good reproducibility, stable and reliable slow-release drug and the like.
Description
technical field [0001] The invention relates to an oral sustained-release pellet of sinomenine, an effective monomer of traditional Chinese medicine, in particular to a preparation method of an oral sustained-release pellet of sinomenine or a salt thereof. Background technique [0002] Sinomenine is an alkaloidmonomer extracted from the traditional Chinese medicine Sinomenuim Scutum Retd.et et wils. Its hydrochloride is often used in medicinal preparations. Sinomenine has anti-inflammatory, immunosuppressive, analgesic, antihypertensive, antiarrhythmic and other pharmacological effects. It has been clinically proven to have good curative effect in the treatment of rheumatoid arthritis and other rheumatism and arrhythmia. (Liu Qiang et al., Chinese Herbal Medicine, 1997, 28(4): 247-249) (Yidandan et al., Chinese Journal of Hospital Pharmacy, 2002, 22(8): 465-467) Sinomenine was formally approved as a national medicine in 1996. The important protected varieties are recorded...
Claims
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