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Use of stephanine and hydrochloride thereof in preparing anti-hepatitis virus medicine

A stephanine and a technology for preparing medicines, which are applied in the field of medicine of stephenine and its hydrochloride, and can solve problems such as slow action

Inactive Publication Date: 2009-08-19
河南省医药科学研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some medicines are slower acting and take longer to see results

Method used

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  • Use of stephanine and hydrochloride thereof in preparing anti-hepatitis virus medicine
  • Use of stephanine and hydrochloride thereof in preparing anti-hepatitis virus medicine
  • Use of stephanine and hydrochloride thereof in preparing anti-hepatitis virus medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Example 1 Preparation method of Stephanine Hydrochloride Injection:

[0069] Measure 1500mL of water for injection, heat it to about 50°C, add 10.0g of raw drug for injection, and dissolve. Add 0.1% activated carbon for needles, stir well, keep warm for 15 minutes, and filter. After washing with an appropriate amount of water for injection, add to 2000mL, fine filter with a G4 vertical fused glass funnel, potting, sterilization, and leak detection to obtain stephine hydrochloride injection. (Specification: 10mg / 2mL).

Embodiment 2

[0070] Example 2 Stephanine test solution preparation method:

[0071] Dissolve Stephanine with an appropriate amount of 0.1mol / L hydrochloric acid, prepare 5mg / mL with distilled water, adjust the pH to 3.5-4.0 with 1.0mol / L NaOH and dilute to the desired concentration.

Embodiment 3

[0072] Example 3 Preparation of Stephanine Hydrochloride Freeze-dried Powder Injection:

[0073] Take 1.1 grams of Stephanine Hydrochloride (Prime) raw material for injection (purity 99%), add 1000 mL of water for injection (50 ° C), stir to dissolve, add 10 grams of mannitol, stir to dissolve, and filter through a 0.22 gm microporous membrane Sterilize, test that the content of stephanine hydrochloride (vegetable) reaches more than 99% of the labeled amount, then pack in 2mL / bottle. Freeze-drying is carried out, and the freeze-drying conditions are a freeze-drying temperature of -20 to -35° C., a vacuum of 50 to 200 Pa, and a time of 24 hours. Then out of the box, sealing, leak detection, labeling.

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Abstract

The invention relates to application of stephanine and hydrochloride thereof in the field of medicine, namely the stephanine or cepharanthine hydrochlofide is taken as an effective ingredient to prepare an anti-hepatitis B virus drug. The research shows that: the median toxic concentration (TC50) of the CH to cells is 2.09mu g.ml; and the CH can inhibit the synthesis of HBV DNA in the cells (P is less than 0.01) and is dose-dependent, the inhibition ratio of the CH to the HBV DNA in supernatant fluids of the cells is more than 50 percent when the dose is more than 0.5mu g.mL, IC50 of the CH is 0.324mu g.mL, the therapeutic index TI is equal to 6.45 (the TI is more than 2.0 and less than 10.0), and the CH has stronger effect of inhibiting the synthesis of the HBV DNA and is an effective low-toxicity drug. The invention develops novel pharmaceutical application of the stephanine and the hydrochloride of the stephanine, has the advantages of rich source of preparation raw materials, low cost, small toxic side effect, and simple preparation technology, can be prepared into oral dosage forms, injection dosage forms, tablets and the like, and has convenient use.

Description

technical field [0001] The present invention relates to the use of stephanine and its hydrochloride, in particular to the use of stepherine and its hydrochloride in the field of medicine. Background technique [0002] Hepatitis B is a worldwide disease caused by the hepatitis B virus. The incidence rate is high in developing countries. According to statistics, there are more than 280 million asymptomatic carriers (HBsAg carriers) in the world, and my country accounts for more than 100 million. Antiviral treatment is an important measure for patients with chronic HBV infection and persistently positive viral replication indicators. Current antiviral drugs are not very effective. After application, it can temporarily inhibit HBV replication, and this inhibitory effect disappears after drug withdrawal, so that the original inhibited indicators return to the original level. Some medicines are slower acting and take longer to see results. [0003] Cepharanthine is an alkaloid...

Claims

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Application Information

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IPC IPC(8): A61K31/4741A61P31/12A61P1/16
Inventor 王庆端郑立运杨崇仁王一飞赵志鸿张颍君江金花王东阳钱垂文刘晨江
Owner 河南省医药科学研究院
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