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Leonurine hydrochloride tablet and preparation method thereof

A technology of leonurine hydrochloride and tablets, which can be used in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve problems such as unacceptable and large dosage for patients, and achieve stable quality, avoid residues, and cheap raw materials Easy to get effect

Active Publication Date: 2021-06-11
NANJING UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Clinically, motherwort ointment, motherwort granule and other dosage forms made from the crude extract of motherwort are taken by patients in large quantities, which are difficult to accept

Method used

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  • Leonurine hydrochloride tablet and preparation method thereof
  • Leonurine hydrochloride tablet and preparation method thereof
  • Leonurine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051]Considering the large proportion of auxiliary materials, starch, sucrose, microcrystalline cellulose, etc. are now used as fillers. The proportion of other excipients remains unchanged, of which the main drug accounts for 5%, the disintegrant accounts for 5%, and the lubricant accounts for 0.5%. The fluidity of the granules, compression formability, hygroscopicity, economic cost, tablet appearance, disintegration time, etc. were used as the investigation indicators to compare the differences among the formulations.

[0052] Prescription 1: The filling agent is 8950mg starch, 500mg leonurine hydrochloride, 500mg crospovidone, and 50mg magnesium stearate.

[0053] Prescription 2: The filler is 8950 mg of sucrose, 500 mg of motherurine hydrochloride, 500 mg of crospovidone, and 50 mg of magnesium stearate.

[0054] Prescription 3: The filler is 8950 mg of microcrystalline cellulose, 500 mg of motherurine hydrochloride, 500 mg of crospovidone, and 50 mg of magnesium stearat...

Embodiment 2

[0057] Considering the large proportion of excipients, lactose, dextrin, pregelatinized starch, etc. are now used as fillers. The proportion of other excipients remains unchanged, of which the main drug accounts for 5%, the disintegrant accounts for 5%, and the lubricant accounts for 0.5%. Taking whether the granules are easy to form, whether they are sticky and punchable during tablet compression, compressibility, tablet appearance, and disintegration time limit, etc., are used as inspection indicators to compare the differences in various formulations and determine the appropriate type of filler.

[0058] Prescription 1: The filler is lactose 8950mg, leonurine hydrochloride 500mg, crospovidone 500mg, magnesium stearate 50mg;

[0059] Prescription 2: The filler is dextrin 8950mg, motherurine hydrochloride 500mg, crospovidone 500mg, magnesium stearate 50mg;

[0060] Prescription 3: The filler is 8950 mg of pregelatinized starch, 500 mg of motherurine hydrochloride, 500 mg of ...

Embodiment 3

[0063] In order to investigate the effects of different types of disintegrants on the preparation process and disintegration time of prescription tablets, dry starch and low-substituted hydroxypropyl cellulose were used as disintegrants. In combination with the filler screened in Example 2, the content of other adjuvants remains unchanged. The economic cost, whether the granules are easy to form, whether they are sticky and punchable during tablet compression, compressibility, tablet appearance, and disintegration time limit are used as the inspection indicators. Compare the differences in each formulation to determine the appropriate type of disintegrant.

[0064] Prescription 1: Leonurine hydrochloride 500mg, disintegrating agent is dry starch 500mg, magnesium stearate 50mg.

[0065] Prescription 2: The disintegrating agent is 500 mg of low-substituted hydroxypropyl cellulose, 500 mg of motherwortine hydrochloride, and 50 mg of magnesium stearate.

[0066] The above two pr...

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Abstract

The invention discloses a leonurine hydrochloride tablet and a preparation method thereof, and belongs to the technical field of medicines. The tablet prepared by the invention mainly comprises the following components in parts by weight: 500 mg of leonurine hydrochloride, 8750 mg of a filler, 500 mg of a disintegrating agent, 200 mg of an adhesive and 50 mg of a lubricant. In the preparation process, the leonurine hydrochloride, the filling agent and the disintegrating agent are firstly mixed, then the adhesive aqueous solution is added to prepare a soft material, then granulation is performed, and finally tabletting and coating are performed on the soft material, the lubricant and the adhesive dry powder. The preparation process comprises the steps of mixing of raw materials and auxiliary materials, wet granulation, drying, size stabilization, total mixing and tabletting. The leonurine hydrochloride raw material medicine is prepared into tablets for the first time; organic solvents such as ethanol are not used in the preparation method, so that organic solvent residues are avoided; the dissolution rates of the leonurine hydrochloride tablets prepared by the invention in water dissolution media with the pH values of 1.2, 4.5 and 6.8 respectively reach about 85% within 30 minutes. The preparation process is cheap and easily available in raw materials, stable in quality and suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a tablet made of leonurine hydrochloride as a crude drug for treating menopausal syndrome. Specifically, it is the first time that motherwortine hydrochloride is used as a raw material and formulated with pharmaceutical auxiliary materials in a certain proportion to make tablets, which belongs to the field of preparations. Background technique [0002] Menopausal syndrome also generally refers to the decline of ovarian function and estrogen level in women before and after menopause, surgical removal of ovaries or other reasons, resulting in dysfunction of the hypothalamus-pituitary-ovary axis, mainly autonomic dysfunction, accompanied by A group of clinical syndromes of mental and psychological symptoms. [0003] Clinically, the motherwort ointment, motherwort granule and other dosage forms mainly made of the crude extract of motherwort are taken by patients in large amounts,...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/36A61K47/26A61K47/32A61K47/12A61K31/235A61P15/12
CPCA61K9/2095A61K9/2059A61K9/2027A61K9/2018A61K9/2054A61K9/2013A61K31/235A61P15/12
Inventor 陈国广任丽莉严世裕
Owner NANJING UNIV OF TECH
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