Oral sustained releasing micro-tablets of tuduranine and their preparation

A technology of slow-release pellets and sinomenine, applied in pill delivery, sugar-coated pills, pharmaceutical formulations, etc., to achieve good reproducible results

Inactive Publication Date: 2005-02-23
SHANGHAI INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, how to improve some shortcomings of sustained-release tablets is a very realistic problem from the perspective of clinical treatment.

Method used

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  • Oral sustained releasing micro-tablets of tuduranine and their preparation
  • Oral sustained releasing micro-tablets of tuduranine and their preparation
  • Oral sustained releasing micro-tablets of tuduranine and their preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Pellet core 200g particle size is 0.7mm

[0034] Sinomenine Hydrochloride 70g

[0035] HPMC 10g

[0036] PEG6000 1g

[0037] 20 grams of water

[0038] (The above is the prescription of the medicine)

[0039] Surelease  70 grams

[0040] 50 grams of water

[0041] (coating prescription)

[0042] usefigure 1 The procedure shown is for preparation:

[0043] (1) the medicine prescription is prepared into suspension, and its particle diameter is 10 microns;

[0044] (2) The inert pellet core is placed in the boiling dryer 1, and hot air is introduced from the bottom of the dryer 1 to make the inert pellet core in a fluidized state, and the suspension of step (1) is removed from the bottom of the dryer 1. After spraying through nozzle 2, the suspension is sprayed on the inert pellet core and dried;

[0045] Hot air temperature: 45℃, material temperature: 30℃, atomization pressure: 1.5bar; wind speed: 0.2~2m / s

[0046] (3) Continue to introduce hot air to k...

Embodiment 2

[0049] Ball core 200g

[0050] Sinomenine Hydrochloride 100g

[0051] HPMC 15g

[0052] PEG6000 1.5g

[0053] 30 grams of water

[0054] (The above is the prescription of the medicine)

[0055] Surelease  120 grams

[0056] HPMC 6g

[0057] 180 grams of water

[0058] (coating prescription)

Embodiment 3

[0060] Ball core 200g

[0061] Sinomenine Hydrochloride 50g

[0062] HPMC 5.6g

[0063] PEG6000 0.8g

[0064] 12 grams water

[0065] (The above is the prescription of the medicine)

[0066] Eudragit  RS-100 20g

[0067] Eudragit  RL-100 3g

[0068] 2 g citric acid triacetic acid

[0069] 10g talcum powder

[0070] 95% ethanol 250ml

[0071] (The above is the coating prescription)

[0072] The preparation method is the same as the example.

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Abstract

An orally applied slow-releasing micropill of tuduranine or its salt is composed of core and coated layer. Said core is prepared from tuduranine hydrochloride powder and fillers. Said coated layer is prepared from ethyl cellulose.

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 alkaloid monomer extracted from the traditional Chinese medicine Sinomenuim Scutum Retd.et et wils. Medicinal preparations use its hydrochloride more. Sinomenine has anti-inflammatory, immunosuppressive, analgesic, antihypertensive, antiarrhythmic and other pharmacological effects. (Liu Qiang et al., Chinese Herbal Medicine, 1997, 28(4): 247-249) (Yi Dandan et al., Chinese Journal of Hospital Pharmacy, 2002, 22(8): 465-467) Sinomenine was officially approved as a national Important protected species, contained in the eighteenth volume of the Ministry of Health's Drug Standards (Traditional Chinese Medicine Ingredient Preparations). [0003] At present, the conventional prep...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4748A61P9/06A61P9/12A61P19/02A61P29/00A61P37/06
Inventor 包泳初陈庆华潘峰瞿挺
Owner SHANGHAI INST OF PHARMA IND
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