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Thesium chinense tablet and preparation method and application thereof

A technology of Bairui tablet and Bairui grass, applied in the field of Bairui tablet and its preparation, can solve the problems of low in vitro dissolution rate, low bioavailability, large difference in tablet weight and the like

Active Publication Date: 2020-01-03
HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Through the research on the existing Bairui Tablets, it was found that because of the poor water solubility of the active ingredient flavonoids in Thymeca officinalis, the poor oral absorption effect, and the low dissolution rate in vitro, resulting in low bioavailability in vivo, oral administration of Thymeca officinalis Tablets have a short half-life in the human body. Therefore, in order to maintain a stable blood concentration, a large dose or multiple doses must be administered. However, large doses or multiple doses will affect the adaptability of patients, especially children. , also aggravated the toxic and side effects. In addition, the existing Bairui tablets also have the problems of poor stability and large differences in tablet weight.

Method used

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  • Thesium chinense tablet and preparation method and application thereof
  • Thesium chinense tablet and preparation method and application thereof
  • Thesium chinense tablet and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0023] Experimental Example 1 Prescription Screening

[0024] 1. Preparation of test samples:

[0025] The main drug of this product is thyme extract, and its active ingredient is flavonoid. For the convenience of patients, the tablet weight is planned to be controlled at 400mg / tablet. The prescription screening experiments are shown in Table 1. The preparation process is as follows: (1) pass the above-mentioned auxiliary materials and main ingredients through 80-mesh and 100-mesh sieves respectively, and set aside; (2) take the adhesive and add an appropriate amount of water, and use a dispersing homogenizer to mix evenly to obtain a mass percentage of 7% (3) the thyme extract (prepared according to the method of the following example 1), filler and lubricant are mixed uniformly by the equal addition method to obtain the mixed material, and the above-mentioned adhesive is added Mixture solution, granulation, drying, and granulation to obtain Bairui granules. (4) Take the s...

experiment example 2

[0038] Experimental Example 2 Stability Investigation

[0039] The tablets prepared by Prescription 1 and Prescription 5 were used as test substances and tested as follows.

[0040] (1) Illumination stability: place the test substance under 25°C and 4500 Lux light conditions to measure the drug stability for 5 days and 10 days, respectively, take samples at the same time on the 5th and 10th day of the experiment period, and use the above-mentioned HPLC method to determine And calculate the 12h cumulative dissolution rate of flavonoids, the results are shown in Table 3, the results show that the tablets prepared by prescription 1 and prescription 5 all have good light stability.

[0041] (2) Stability at high temperature: place the test substance at 60°C to measure the drug stability for 5 days and 10 days respectively, take samples at the same time on the 5th day and the 10th day during the experiment period, use the above HPLC method to measure and calculate the 12h stability...

Embodiment 1

[0046] Composition: 800g of thyme extract, 200g of lactose, 20g of hydroxypropyl cellulose, 50g of magnesium stearate, 100g of PEO (WSR303);

[0047] Preparation method: take Thyme officinalis and add 75% ethanol aqueous solution by volume, extract 3 times, extract for 3 hours each time, combine the extracts, concentrate under reduced pressure to a relative density of 1.15, and then vacuum-dry to obtain Thyme officinalis extract . Pass the above auxiliary materials and main ingredients through 80-mesh and 100-mesh sieves respectively, and set aside; take hydroxypropyl cellulose, add appropriate amount of water, and use a dispersing homogenizer to mix evenly to prepare a binder solution with a mass percentage of 7%, set aside; The thyme extract, lactose and magnesium stearate are uniformly mixed according to an equal delivery method to obtain a mixed material, the above-mentioned binder solution is added, granulated, dried, and sized to obtain the thyme granule. Take PEO (WSR3...

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PUM

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Abstract

The present invention relates to the field of thesium chinense preparations and particularly relates to a thesium chinense tablet and a preparation method and an application thereof. The thesium chinense comprises the following raw materials in parts by weight: 80-120 parts of a thesium chinense extract, 10-20 parts of lactose, 1-5 parts of hydroxypropyl cellulose, 2-8 parts of magnesium stearateand 10-30 parts of polyoxyethylene WSR 303. The prepared tablet is good in slow release effect, high in dissolution rate, good in stability, good in fluidity, smooth in surface and small in tablet weight difference.

Description

technical field [0001] The invention relates to the field of barley preparations, in particular to a barley tablet, a preparation method and application thereof. Background technique [0002] Thyme grass, the Chinese aliases are all milk grass, ground pomegranate, fine beard grass, a pine, accumulated herbs, pearl grass, Artemisia phoenix buds, Qinglong grass, coral grass, grass-eating grass, stone rapeseed, pine hair ginseng, small Grass and white wind grass, etc., are the general designation of various plant medicinal materials of the genus Thyme (Thesium L.) in the family Santalaceae (Santalaceae). They are distributed in tropical and temperate regions. There are 8 species in my country, which are produced in all provinces; The dried whole herb of Thesium chinense Turcz. or its variant T. chinense Turcz. varlongipedunculatum Chu. Studies have found that thymegrass mainly contains polysaccharides, glycosides, flavonoids, alkaloids, steroids, organic acids and mineral elemen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K36/185A61K47/38A61K47/26A61K47/10A61P11/00A61P11/04A61P11/10A61P11/14
CPCA61K9/2018A61K9/2031A61K9/2054A61K36/185A61P11/00A61P11/04A61P11/10A61P11/14
Inventor 管悦琴罗雪峰郑卫兵焦忠强
Owner HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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