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New crystal form of andrographolide

A technology of andrographolide and crystallization, applied in the field of medicine, can solve problems such as poor water solubility of andrographolide

Active Publication Date: 2013-06-12
成都天台山制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0011] Although the oral preparations of andrographolide, especially some solid preparations such as tablets, capsules, etc., have been used clinically as commonly used medicines, due to the poor water solubility of andrographolide, as a crystalline substance, it is necessary to obtain a kind with good performance. It is eagerly expected by those skilled in the art in order to facilitate the preparation of preparations

Method used

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  • New crystal form of andrographolide
  • New crystal form of andrographolide
  • New crystal form of andrographolide

Examples

Experimental program
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Effect test

preparation example Construction

[0056] Preparation of andrographolide raw material:

[0057] The raw material of andrographolide was prepared according to the method of Example 1 in CN102382083A (Chinese Patent Application No. 201010268676.0). After determination, its content is 98.1% (HPLC), and powder X-ray diffraction is determined. In the powder X-ray diffraction pattern represented by 2θ angle, there is no Diffraction peaks.

Embodiment 1

[0058] Embodiment 1: preparation andrographolide crystallization

[0059] Place 50 g of the andrographolide raw material prepared according to the method of Example 1 in CN102382083A above in 1000 ml of 98% ethanol, heat to boiling and stir to dissolve the andrographolide, add 50 ml of n-butanol while hot, and stir evenly , stand still, let cool to room temperature to separate out the precipitate, filter out the precipitate, wash with absolute ethanol, then wash with water, and dry with air heat at 60-65°C, to obtain that, the yield is 96.3%, and the content is 99.2% (HPLC) , determined by powder X-ray diffraction, the results are as follows figure 1 .

[0060] The results of powder X-ray diffraction show that in the powder X-ray diffraction pattern represented by 2θ angles, the crystals have There are diffraction peaks at °; particularly, in the powder X-ray diffraction pattern represented by 2θ angles, the crystals are at about 9.82°, about 11.92°, about 14.68°, about 15...

Embodiment 2

[0063] Embodiment 2: preparation andrographolide crystallization

[0064] The commercially available andrographolide bulk drug (National Medicine Accreditation H51023720, produced by Chengdu Tiantaishan Pharmaceutical Co., Ltd., the test report meets the requirements of the 2010 edition Chinese Pharmacopoeia Part One "andrographolide" variety, which is about 9.82°, about 11.92°, About 15.62 °, no diffraction peak at about 22.56 °) 50g is placed in 95% ethanol of 1000ml, heated to boiling and under stirring so that andrographolide dissolves, add 20ml n-butanol while hot, stir evenly, leave standstill, Let it cool to room temperature to precipitate the precipitate, filter the precipitate, wash with absolute ethanol, then wash with water, and dry in vacuum at 60-65°C to obtain that, the yield is 96.7%, the content is 99.3% (HPLC), and the powder X-ray is determined Diffraction, as a result, in the powder X-ray diffraction pattern represented by 2θ angle, the crystal is in terms...

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Abstract

The invention relates to a new crystal form of andrographolide, and specifically relates to a compound expressed as the following formula. By Cu-K alpha radiation, the compound has a diffraction peak on about 15.62 degrees in a powder X-ray diffraction spectrum expressed by a 2-theta angle. Furthermore, the invention discloses a preparation method of the new crystal form of andrographolide, as well as a pharmaceutical composition comprising the new crystal form of andrographolide. The new crystal form of andrographolide disclosed by the invention has an excellent pharmaceutical performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to andrographolide and a new crystal form of the andrographolide. Background technique [0002] Andrographis paniculata (Andrographis paniculata (Burm. F.) Nees) is the dry aerial part of the Acanthaceae plant. It is harvested when the stems and leaves are luxuriant in early autumn and dried in the sun. Andrographis paniculata, also known as spring lotus and autumn willow, is a joy at first sight, Lamicarpa, bitter gall grass, golden vanilla, golden ear hook, Indian grass, bitter grass and so on. It has the effects of clearing away heat and detoxification, reducing inflammation, reducing swelling and relieving pain. It is mainly used to treat bacillary dysentery, urinary tract infection, acute tonsillitis, enteritis, pharyngitis, pneumonia and influenza, etc. It can be used externally to treat sores, furuncles, swollen toxins, and traumatic infections. Mainly produced in Guangdong,...

Claims

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Application Information

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IPC IPC(8): C07D307/60A61K31/365A61P29/00A61P31/04A61P11/00A61P1/12
Inventor 赵东明方专王敬江威侯建轩董国明
Owner 成都天台山制药股份有限公司
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