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Rotundine orally disintegrating tablets and preparation method thereof

A technology of orally disintegrating tablets and mixtures, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, etc. Problems such as poor decoding performance

Inactive Publication Date: 2012-05-16
QUANTUM HI TECH BEIJING RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In China, the preparation technology of orally disintegrating tablets started relatively late. At present, most of them adopt the direct compression method to prepare orally disintegrating tablets. Most disintegrants are insoluble in water, so the orally disintegrating tablets prepared by this method often have a gritty feeling after tasting, which affects the taste and compliance of patients when taking it; and the disintegration of the preparation will be very slow
Some domestic scholars also use the freeze-drying method to prepare this dosage form, but most of them follow the shortcomings of the direct compression method, adding a large amount of disintegrants and other excipients, which makes the performance of the orally disintegrating tablets prepared poor.

Method used

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  • Rotundine orally disintegrating tablets and preparation method thereof
  • Rotundine orally disintegrating tablets and preparation method thereof
  • Rotundine orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0172] The preparation formula of the present invention is made up of following components:

[0173] Rotundine 30.00g

[0174] Glycine 4.00g

[0175] Pullulan 4.40g

[0176] Xanthan gum 0.20g

[0177] Sucralose 0.20g

[0178] Mint essence 0.20g

[0179] Purified water 161.00g

[0180] A total of 1000 pieces were made.

[0181] The specific preparation method is as follows: add rotundine, glycine, pullulan, sucralose, and mint essence to the fully dissolved xanthan gum solution, and mix evenly; add an appropriate amount of purified water to make all of the above The total amount of purified water is the prescription amount of purified water, and the emulsifier is mixed to make a uniform solution; after the solution is vacuum degassed, it is accurately injected into the mold; after pre-freezing with liquid nitrogen at -120°C to -130°C for 3 minutes, Incubate at -10°C for 12 hours, transfer to a lyophilizer, and freeze-dry for 6 hours at a pressure of 0.1 mbar at -20°C to ...

Embodiment 2

[0183] The preparation formula of the present invention is made up of following components:

[0184] Rotundine 30.00g

[0185] Mannitol 4.00g

[0186] Pullulan 4.40g

[0187] Xanthan gum 0.20g

[0188] Sucralose 0.20g

[0189] Mint essence 0.25g

[0190] Purified water 160.95g

[0191] A total of 1000 pieces were made.

[0192] The specific preparation method is as follows: add rotundine, mannitol, pullulan, sucralose, and mint flavor to the fully dissolved xanthan gum solution, and mix evenly; add an appropriate amount of purified water to make all of the above The total amount of purified water added is the prescribed amount of purified water, and the emulsifier is mixed to make a uniform solution; after the solution is vacuum degassed, it is accurately injected into the mold; after pre-freezing with liquid nitrogen at -110°C to -120°C for 4 minutes , transferred to a lyophilizer, and lyophilized under the conditions of 0.05 mbar pressure and -20°C to 20°C for 4.5 hou...

Embodiment 3

[0194] The preparation formula of the present invention is made up of following components:

[0195] Rotundine 30.00g

[0196] Glycine 2.20g

[0197] Mannitol 1.80g

[0198] Pullulan 4.40g

[0199] Konjac Gum 1.20g

[0200] Sucralose 0.15g

[0201] Mint essence 0.20g

[0202] Purified water 160.05g

[0203] A total of 1000 pieces were made.

[0204] The specific preparation method is as follows: add rotundine, glycine, mannitol, pullulan, sucralose, and mint flavor to the fully dissolved konjac gum solution, and mix evenly; add an appropriate amount of purified water to make the above The total amount of purified water added is the prescribed amount of purified water, and the emulsifier is mixed to make a homogeneous solution; the solution is vacuum degassed, and then accurately injected into the mold; pre-frozen at -100°C to -110°C for 6 minutes with liquid nitrogen Afterwards, transfer to a lyophilizer, and freeze-dry for 3 hours at a pressure of 0.01 mbar at -20°C t...

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Abstract

The invention relates to rotundine orally disintegrating tablets and a prescription and process for preparing the rotundine orally disintegrating tablets by adopting a freeze drying method. The rotundine orally disintegrating tablets are prepared from rotundine as a main medicine and pharmaceutic adjuvants, can be taken without water, are capable of rapidly disintegrating after entering the mouth, are suitable for taking by patients suffered from dysphagia, such as the old, children and the like, are simultaneously suitable for medications in the travel journey under the condition of being not easy to obtain a water source, has the advantages of convenience for taking, high absorption speed, small fast pass effect, little irritation to digestive tract mucosa, wide market application prospect and the like, and are capable of remarkably reducing side effects of rotundine. In addition, the invention also relates to a preparation method of the rotundine orally disintegrating tablets.

Description

Technical field: [0001] The invention relates to a rotundine orally disintegrating tablet and a preparation method thereof, in particular to a rotundine orally disintegrating tablet prepared by a freeze-drying method. Background technique: [0002] The chemical name of Rotundine is 2,3,9,10-tetramethoxy-5,8,13,13a-tetrahydro-6H-dibenzo[a,g]quinazine. Has analgesic, sedative, hypnotic and stabilizing effects. The analgesic effect is stronger than that of general antipyretic and analgesic drugs, and the analgesic effect occurs 10 minutes after taking the drug, and can last for 2-5 hours; it has a good analgesic effect on dull pain caused by the gastrointestinal system; it is also effective for menstrual pain; It is more suitable for insomnia, especially insomnia caused by pain, and there is no aftereffect after waking up. It is a non-narcotic analgesic widely used in clinical practice. [0003] At present, the dosage forms of rotundine approved in China include ordinary tab...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4375A61K47/36A61J3/10A61P25/20A61P29/00
Inventor 王丛威王洪飞赵淑欣王丽滨周立运
Owner QUANTUM HI TECH BEIJING RES INST
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