Stable compound rabdosia rubescens preparation and preparation method thereof

A technology of Oridinus japonicus and its compound, which is applied in the field of compound Oridinus japonicus preparation and its preparation, can solve the problems affecting tablet drug stability and dissolution rate, hidden dangers of quality and safety, and affecting drug quality, so as to protect the main drug components, Low production cost, guaranteed efficacy of medication

Pending Publication Date: 2021-05-07
河南济世药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because Rubescensin A has extremely poor water solubility, extremely bitter taste and is prone to degradation, taking into account that the drugs containing Rubescensin A need to be convenient for patients to use and have good compliance, more coating processes are added, but usually in order to ensure that the tablets Under the premise of high strength, it will often affect the stability and dissolution rate of the tablet drug, and there is still a common problem of degradation of the active ingredient oridonin during storage, which seriously affects the quality of the drug, and there are quality and safety risks

Method used

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  • Stable compound rabdosia rubescens preparation and preparation method thereof
  • Stable compound rabdosia rubescens preparation and preparation method thereof
  • Stable compound rabdosia rubescens preparation and preparation method thereof

Examples

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Effect test

Embodiment 1~3

[0032]A stable compound Donglingcao preparation, which is made by extracting and concentrating the main raw materials of Donglingcao, licorice, bellflower and peppermint into an extract, and adding auxiliary materials. The mass ratio of the main drug raw materials to auxiliary materials is 1:1.28 , the dosage form is buccal tablet; among the raw materials of the main drug, the mass ratio of Radix Radix Radix Radix Grass, Licorice Root, Platycodon grandiflorum and Peppermint is 1.5:1:1:1; the excipients include filler (sucrose), lubricant (magnesium stearate ), glidant (talc powder), sustained-release agent (polyacrylic acid resin II), compound additives (prepared by mixing hydroxypropyl chitosan and sodium alginate at a mass ratio of 3:1).

[0033] Examples 1-3 The specific dosage of each raw material and supplementary material per 1000 tablets of the compound Oridonium japonicus preparation (buccal tablets) is shown in Table 1.

[0034] Table 1 The consumption of every 1000 p...

Embodiment 4

[0054] A kind of stable compound Oryx bisporum preparation, when the dosage form is oral tablet, the dosage of the main drug raw materials and auxiliary materials are all according to the ratio of Example 1, the difference is that the filler is: sucrose and starch are mixed according to the mass ratio of 4:2 uniform. For the specific dosage of each raw and auxiliary material per 1,000 tablets of the compound Oryx chinensis preparation (oral tablet), refer to the dosage in Example 1, the difference is that 520 g of sucrose is replaced by 347 g of sucrose and 173 g of starch.

[0055] The preparation method of the compound Oridonium japonicus preparation (oral tablet) is prepared according to the steps in Example 1.

Embodiment 5

[0057] A stable compound Oriodontis japonicus preparation, when the dosage form is a capsule, the dosage of the main drug raw materials and auxiliary materials are all in accordance with the ratio of Example 4, the difference is that when preparing the compound Oridonium japonicus formulation (capsule), step 6 is no longer tablet compression , but in capsules.

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Abstract

The invention discloses a stable compound rabdosia rubescens preparation. The stable compound rabdosia rubescens preparation is a tablet or a capsule prepared by taking rabdosia rubescens, liquorice, platycodon grandiflorum and mint as main medicine raw materials, extracting and concentrating the main medicine raw materials into extract and adding auxiliary materials, wherein the mass ratio of the main medicine raw materials to the auxiliary materials is 1: (1.2-1.6); the auxiliary materials comprise a filling agent, a lubricating agent, a flow aid, a sustained release agent and a compound additive; the sustained release agent is selected from one or more than two of polyacrylic resin II, polyacrylic resin III and polyacrylic resin IV; and the compound additive is prepared by mixing hydroxypropyl chitosan and sodium alginate according to the mass ratio of (2-4): 1. The invention also discloses a preparation method of the compound rabdosia rubescens preparation. The stable compound rabdosia rubescens preparation is low in auxiliary material cost and safe to eat, has the advantages of small toxic and side effects, small irritation, good biocompatibility and the like, is relatively long in disintegration time, obviously slows down degradation of oridonin, guarantees the medicine quality and the medication effect, and is simple in preparation process and relatively low in production cost.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a stable compound oridonium japonicus preparation and a preparation method thereof. Background technique [0002] Donglingcao, also known as Binglingcao, is the dry aerial part of Rab-dosia rubescens (Hemsl. ) Hara, a plant of the Labiatae family. The herbaceous part is used as medicine. , Antibacterial, anti-tumor and other effects, it is mostly used to treat diseases such as esophageal cancer and sore throat. Because of its unique medicinal value, Oridonium is widely used in my country. Modern medical research shows that: Oridonin has medicinal value mainly because it contains the diterpenoid oridonin. However, Rubescensin A has extremely poor water solubility, extremely bitter taste, and is prone to degradation, resulting in a decrease in bioavailability, which affects its wide clinical application. [0003] At present, there are mainly syrups...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/534A61K9/22A61K9/52A61K47/12A61K47/02A61K47/32A61K47/36A61K47/26A61P11/04A61P29/00
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/205A61K9/2059A61K9/485A61K9/4858A61K9/4866A61K36/346A61K36/484A61K36/53A61K36/534A61K2236/33A61K2236/331A61K2236/39A61K2236/51A61P11/04A61P29/00A61K2300/00
Inventor 张康黄敬旺赵晖张秋芬
Owner 河南济世药业有限公司
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