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Huperzine osmotic-pump controlled release tablet

A technology of osmotic pump controlled release and huperzine A, which is applied in the field of medicine, can solve the problems of complex process, difficult to control quality stability, unstable drug release, etc., achieve simple composition and preparation process, prolong drug action time, reduce The effect of the number of doses

Inactive Publication Date: 2012-06-27
北京振东生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These technologies have the following problems: drug release is not stable, the process is complicated, quality stability is difficult to control, and injection administration is inconvenient
Although CN101485640A proposes a simple prescription and process for preparing huperzine A osmotic pump controlled-release tablets, which solves the complex problem of the process well, it can only release the drug steadily for 12 hours, and it is difficult to realize drug administration once a day
[0007] A large number of existing experimental studies have confirmed that increasing the osmotic pressure enhancer can increase the release rate of the drug, adding a suspending agent can improve the release stability of the insoluble drug, and the application alone cannot significantly prolong the linear release time of the osmotic pump preparation.
In order to prolong the release time, it is generally solved by increasing the dosage of blockers and increasing the film thickness. figure 1

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] (1) Prescription

[0039]

[0040]

[0041] (2) Preparation process

[0042] Tablet core preparation: mix huperzine A, sodium chloride, HPMC K4M, magnesium stearate, and colloidal silicon dioxide evenly, press into tablets, φ6 punched tablets, pressure control 40-70N, tablet weight 100mg.

[0043] Coating: Dissolve polyethylene glycol 4000 in 5ml of water, add 95ml of acetone, add cellulose acetate and triethyl citrate, and stir for 4 hours. The tablet cores were coated in a coating pan with a rotating speed of 22rpm and a hot air temperature of 40°C. Up to a coating weight gain of 12%.

[0044]Hole punching: dry the coated tablet at 45°C for 24 hours, take it out, and punch holes with laser (φ=0.6mm).

[0045] (3) Preparation of control drug

[0046] Control drug ①

[0047] Prepare according to CN101485640A pilot test prescription:

[0048]

[0049] Process:

[0050] a. Mix huperzine A and other pharmaceutical excipients according to the method of equal...

Embodiment 2

[0068] (1) Prescription

[0069]

[0070]

[0071] (2) Preparation process

[0072] Tablet core preparation: Mix huperzine A, sodium chloride, and carboxymethyl starch sodium evenly, add appropriate amount of water to make soft material, granulate through a 30-mesh sieve, dry at 60°C, granulate at 30 mesh, add magnesium stearate and mix Uniform, tablet pressing, φ6.0 stamping tablet, pressure control 40-70N, tablet weight 100mg.

[0073] Coating: Dissolve polyethylene glycol 4000 in 5ml of water, add 95ml of acetone, add cellulose acetate and triethyl citrate, and stir for 4 hours. The tablet cores were coated in a coating pan with a rotating speed of 22rpm and a hot air temperature of 40°C. Up to a coating weight gain of 12%.

[0074] Hole punching: dry the coated tablet at 45°C for 24 hours, take it out, and punch holes with laser (φ=0.6mm).

[0075] (3) Determination of release rate

[0076] With embodiment 1, measurement result is as figure 2 shown.

Embodiment 3

[0078] (1) Prescription

[0079]

[0080] (2) Preparation process

[0081] Tablet core preparation: Mix huperzine A, mannitol, and hypromellose evenly, add appropriate amount of water to make soft material, granulate through a 30-mesh sieve, dry at 60°C, granulate at 30 mesh, add magnesium stearate and mix Uniform, tablet pressing, φ6.0 stamping tablet, pressure control 40-70N, tablet weight 100mg.

[0082] Coating: Dissolve polyethylene glycol 4000 in 5ml of water, add 95ml of acetone, add cellulose acetate and methyl phthalate, and stir for 4 hours. The tablet cores were coated in a coating pan with a rotating speed of 22rpm and a hot air temperature of 40°C. The weight gain to the coating was 11%.

[0083] Hole punching: dry the coated tablet at 45°C for 24 hours, take it out, and punch holes with laser (φ=0.6mm).

[0084] (3) Determination of release rate

[0085] With embodiment 1, measurement result is as figure 2 shown.

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Abstract

The invention relates to a huperzine osmotic-pump controlled release tablet, which is composed of tablet core containing huperzine and semipermeable film coating with small holes. The huperzine osmotic-pump controlled release preparation is characterized in that the preparation comprises the following components by the weight percent: 0.2-0.6 percent of huperzine in the tablet core, 85-95 percent of osmotic pressure accelerating agent, 1-10 percent of suspending agent and o.1-5 percent of other components. A coating film contains cellulose acetate, PEG (polyethyleneglycol) 4000 and a plasticizing agent, and the proportion of the cellulose acetate, the PEG4000 and the plasticizing agent is 1: (0.3-0.4) : (0.1-0.2). The weight of the coating is increased by 11-13 percent.

Description

field of invention [0001] The invention relates to the technical field of medicine, specifically a drug containing the insoluble drug huperzine A, in particular to an osmotic pump controlled release preparation containing the insoluble drug huperzine A. Background technique [0002] Huperzine A [(-)-Huperzine A, HupA] is a new effective monomer of lycopodium alkaloids isolated from folk herbal medicine Melaleuca (Huperzia serrata Thunb) by Chinese scientist Liu Jiasen in 1986. HupA is white or off-white to slightly yellow crystalline powder, with a melting point of 228-230°C, easily soluble in methanol and chloroform, soluble in ethanol, and insoluble in water. Due to the extremely small dosage of this product, there is no drug detection method for human pharmacokinetic research. Animal experiments show that this product is rapidly and completely absorbed orally, and the distribution is also fast. The half-life of the distribution phase (t1 / 2α) is 9.8 minutes, and the bioav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/36A61K31/4748A61K47/36A61K47/38A61P25/00A61P25/18A61P25/28
Inventor 张加晏海丽娜胡红宇仰振球王瑞峰王玉青
Owner 北京振东生物科技有限公司
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