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Andrographolide nanometer suspension agent

A technology of andrographolide and nanosuspension, applied in the field of medicine, can solve the problems such as inability to realize continuous operation, limited scale-up production, and inconvenient process, achieve a small dispersion coefficient, avoid the growth of the particle size of the preparation, and simplify the process. controllable effect

Active Publication Date: 2019-04-05
SHINEWAY PHARMA GRP LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The closed system used by the ball mill cannot realize continuous operation; there is no filtration system, and the materials and grinding media need to be manually separated after grinding; and the raw material medicine needs to be pre-dispersed in the water system, the process is not simple enough, and the scale-up production is limited
[0006] At the same time, it should be noted that as a highly dispersed nanocolloid system, nanosuspensions have high system free energy, and are prone to stability problems such as aggregation, sedimentation, and aging in aqueous media, which have become important factors that limit their application.

Method used

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  • Andrographolide nanometer suspension agent
  • Andrographolide nanometer suspension agent
  • Andrographolide nanometer suspension agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 Preparation of Andrographolide Nanosuspension—Comparison of Different Instruments

[0046] prescription:

[0047]

[0048] Process:

[0049] (1) ATS high-pressure homogenizer: Dissolve 0.2 g sodium deoxycholate in distilled water, add 6 g of andrographolide after complete dissolution, and use shear dispersion to completely disperse the drug in the aqueous solution containing stabilizers. The mixed solution was passed through a high-pressure homogenizer, 400 and 800 bar were circulated once, and then 1200 bar was circulated 20 times, and an appropriate amount of andrographolide suspension was taken out to measure the particle size to be 1.1 μm, which could not reach the nanometer level. Reduce the amount of prescription andrographolide to 0.6%, and use the same method to circulate through the high-pressure homogenizer 20 times, take out an appropriate amount of andrographolide suspension and measure the average particle size to be 532 nm.

[0050] (2) Micr...

Embodiment 2

[0054] Preparation of embodiment 2 andrographolide nanosuspensions——crude drug without micronization or through micronization

[0055] Take the unmicronized andrographolide raw material drug, adopt the same prescription as in Example 1 and the method in (4) in Example 1 to prepare andrographolide nanosuspensions respectively, and take out an appropriate amount of andrographolide in 0.5 h and 1 h before grinding. The particle size of the ester suspension was determined. Compared with Example 1 (4), that is, the nanosuspension prepared after the micronization of the crude drug. The results are shown in Table 1.

[0056] Table 1 Average particle size of nanosuspension prepared by micronization or non-micronization of andrographolide API

[0057]

[0058] It can be seen from Table 1 that the particle size of the API is smaller after micronization and grinding at the same time. But at the same time, the method of the present invention has a higher grinding efficiency for part...

Embodiment 3

[0059] The preparation of embodiment 3 andrographolide nanosuspensions—adding or not adding stabilizer

[0060] prescription:

[0061]

[0062] Process:

[0063] The process of (4) in Example 1 was used to prepare the andrographolide nanosuspension. Before grinding, 0.5, 1.0, and 1.5 h were taken out from the discharge port to measure the particle size of the andrographolide nanosuspension. Compared with the andrographolide nanosuspension prepared by adding stabilizer in Example 2. The results are shown in Table 2.

[0064] Table 2 The average particle size of andrographolide nanosuspension prepared with or without stabilizer in the formulation

[0065]

[0066] It can be seen from Table 2 that after adding a stabilizer, the particle size of the drug particles can be continuously reduced with the increase of grinding time, but without adding a stabilizer, the drug particles not only did not decrease but increased after grinding for 1 h. It can be seen that adding a s...

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Abstract

The invention provides an andrographolide nanometer suspension agent. The andrographolide nanometer suspension agent includes andrographolide particles with the effective average particle size less than 1000 nm and one or more anionic surface stabilizers. According to the nanometer suspension agent, the prescription is simple, the preparation process is simplified and controllable, industrialization is easy, the efficiency is high, preparation stability is good, and dilution resistance is achieved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a nano-suspension of andrographolide and its preparation method and application. Background technique [0002] Andrographolide is a diterpene lactone compound extracted from Andrographis paniculata, which has excellent anti-inflammatory, antibacterial, antiviral, antitumor, immune regulation, treatment of cardiovascular and cerebrovascular diseases, liver protection and gallbladder. application value. Clinically used to treat bacillary dysentery, leptospirosis, meningitis, pneumonia, upper respiratory tract infection, etc., because of its good treatment effect on bacterial or viral infections, it enjoys the reputation of "Chinese medicine antibiotics". [0003] At present, CFDA has approved the production of oral dosage forms such as andrographolide tablets, capsules, and dropping pills. Although these preparations have a certain inhibitory effect on bacteria and viruses, thei...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/365A61K47/28A61K47/26A61P1/12A61P31/04A61P25/00A61P11/00A61P31/12
CPCA61K9/10A61K31/365A61K47/26A61K47/28
Inventor 邓意辉康乐林湘云宋艳志刘欣荣刘铭琦秦玉霞张纲赵淑欣
Owner SHINEWAY PHARMA GRP LTD
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