WO1997025054A1

WO1997025054A1 - An antibacterial or antiviral pharmaceutical composition and preparation thereof

Info

Publication number: WO1997025054A1
Application number: PCT/CN1997/000001
Authority: WO
Inventors: Hong Li; Leting Wu
Original assignee: Hong Li; Leting Wu
Priority date: 1996-01-09
Filing date: 1997-01-08
Publication date: 1997-07-17
Also published as: CN1154246A; AU1364497A

Abstract

An antibacterial or antiviral pharmaceutical composition and preparation thereof are disclosed. The composition comprises the active components which are respectively extracted from the roots of Scutellaria baicalensis, the fructus and the leaves of Forsythia suspensa, if necessary, and the flower buds and the leaves of Lonicera joponica, and a conventional pharmaceutical excipient. During the preparing process the attention is paid to the tannin and blood-dissolving saponin are removed and the active component unstable to acids and alkalis is protected. Therefore, the composition has advantages including high purity, small dosage, good potency and little irritation. It can be formulated in the various dosage forms by simple method and be suitable for industrial production.

Description

Antibacterial and antiviral medicine composition and preparation method thereof

Field of invention

The present invention relates to a pharmaceutical composition and a preparation method thereof. More specifically, the present invention relates to an antibacterial and antiviral pharmaceutical composition and a preparation method thereof.

Background of the invention

Most of the existing proprietary Chinese medicine preparations are prepared by traditional methods. The finished product has many impurities, large dosages, low bioavailability, and it is not clear what the active ingredients are, and it is impossible to control the active ingredient content and intrinsic quality, which has caused a lot of history in China. The curative effect is accurate, widely used, and the well-known Chinese patent medicine preparations in China are not recognized by the international community. The scope of use is limited to China, Japan and parts of Southeast Asia; such as Sanjiuweiqin granules, although approved by the US FDA, Entered the US market, but was only approved in the form of health food. These proprietary Chinese medicines are not recognized internationally as medicines. For example, it consists of scutellaria baicalensis, honeysuckle and forsythia. It is used to treat upper respiratory infections and has antibacterial and antiviral properties. The preparation of Shuanghuanglian powder has the Chinese patent and the invention patent number is 891036-8. However, due to the rough processing of traditional Chinese medicine raw materials to make injections, there are many impurities, low purity, dark colors, and injections. Pain, allergic reactions; and honeysuckle, even ¾ Hemolytic saponins and tannins are difficult to remove by this process. At the same time, the main active ingredients in the prescription are extremely unstable under acid and alkali conditions, and the process does not pay attention to protection when acid subtraction treatment is used, resulting in most of the active ingredients Destroyed. The purpose of the present invention is to overcome the shortcomings, provide an antibacterial antiviral pharmaceutical composition with good curative effect, small dose, high purity, and low irritation and provide a preparation method thereof.

Detailed description of the invention

The antibacterial and antiviral pharmaceutical composition provided by the present invention contains 0.02-98.18% of baicalin total glycosides extracted from Scutellaria baicalensis, 0.02-98.18% of forsythia glucosides extracted from forsythia or forsythia leaves and optionally contains excipients Agent. In another embodiment of the present invention, the pharmaceutical composition further contains 0.40-88.10% of the total organic acid of honeysuckle extracted from honeysuckle or honeysuckle leaves.

The excipients used in the pharmaceutical composition of the present invention are pharmaceutically conventional excipients, such as Span 85, ethyl oleate, dichloromethane, mixed fatty acid glycerol vinegar (type 34), cyclodextrin, sugar Powder, menthol, water tablets, magnesium stearate, acrylic resin, stevioside, etc. The pharmaceutical composition of the present invention can be made into various dosage forms, such as aerosol, according to the specific conditions and conventional preparation techniques Preparations, suppositories, lozenges, capsules; tinctures, water injections, powder injections and so on.

In addition to baicalin, baicalin also contains baicalein, baicalin and other flavonoids. Due to the highest baicalin content and clear pharmacological action, baicalin is used as an index to extract total baicalin, and conventional analysis methods such as ultraviolet spectrophotometry are used. "'1 content, baicalin content in total baicalin

> 70%; The content of baicalin in total baicalin is> 86% when preparing injections;

Forsythia in addition to forsythia vinegar contains saponin, tannin, volatile oil, forsythia, and other ingredients. For the preparation of injections, the hemolytic saponins and tannins need to be removed. Because forsythia has the highest g glycoside content and clear pharmacological effects Therefore, the forsythia glycosides were extracted by using forsythia vinegar ring as an index, and the content was determined by conventional analytical methods such as ultraviolet spectrophotometry. The content of forsythiaside in forsythia glycosides should be> 10%; Free of tannins and hemolytic saponins, containing forsythiaside> 25%

Honeysuckle contains organic acids such as dicaffeoquinic acid and caffeic acid, as well as lutein, saponin, tannin, etc. in addition to chlorogenic acid. According to the extraction method described in the present invention, the above components can be prepared; It is necessary to remove tannins and hemolytic soaps. Because chlorogenic acid has the highest content and is the main active ingredient of antibacterial, the total organic acids of honeysuckle are extracted with chlorogenic acid as an indicator, and routine analysis such as ultraviolet spectrophotometry is used; ¾Γ method Content, the content of chlorogenic acid in total organic acids of honeysuckle should be> 10%; the total organic acid of honeysuckle does not contain tannins and hemolytic saponins when preparing injections, and contains chlorogenic acid> 25%.

The above active ingredients (such as total scutellaria baicalensis, total forsythia glucosides, total honeysuckle organic acids) and excipients are combined to obtain the pharmaceutical composition of the present invention.

The method for preparing the pharmaceutical composition of the present invention can make the pharmaceutical composition of the present invention have good curative effect, small dosage, and remove saponin (caused by hemolysis) and tannin (caused by pain) existing in the fins and honeysuckle. Advantages of high purity and low irritation. Specifically, the preparation method of the present invention includes the following steps:

(i) Preparation of active ingredients:

(a) Preparation of baicalin total glucosides: According to conventional methods, baicalin total baicalsides or baicalin are prepared for oral use; or the obtained total baicalin or baicalin is suspended in water for injection under sterile conditions, and the pH is adjusted to 7.0- 8.0, filter, concentrate, and dry; or pour the concentrate into ethanol to precipitate and dry the precipitate to obtain the total baicalin or baicalin for injection;

(b) Preparation of forsythia total martial arts:

Take forsythia or forsythia leaves, extract them by conventional methods, and concentrate with organic solvents such as n-butanol Take the forsythia total glycosides for oral preparations, aerosols, suppositories, etc. after conventional treatment; dissolve the forsythia total glycosides in water, and add 1-15% gelatin solution, egg white solution or other precipitants dropwise to precipitate tannins Completely, let it stand, filter, and add the saturated solution of bile alcohol ethanol or other precipitating agent to the precipitate to completely precipitate the saponin. After conventional treatment, a refined forsythia glycoside that removes tannins and hemolytic saponins can be obtained; or, Forsythia suspensa or Forsythia suspensa leaves are extracted according to conventional methods. The extraction solution is adsorbed with an adsorbent such as polyamide, macroporous adsorption resin, and silica gel. After impurities are washed away, the solvent is eluted with water, ethanol, acetone, and ethyl acetate to obtain Remove tannin and hemolytic soap forsythia total glycosides or forsythia glycosides; if necessary, (ii) mix the above active ingredients with excipients.

In another embodiment of the preparation method of the present invention, the step (i) further includes:

(c) Preparation of total organic acids of honeysuckle:

Take honeysuckle or leaves, extract them according to conventional methods, and concentrate them with organic solvents such as n-butanol to obtain raw materials for oral preparations, aerosols, suppositories; the above-mentioned n-butanol extract uses sodium bicarbonate-sodium hydrogen phosphate or pH 7 .0 ~ 8.0 buffer extraction, adjust the pH of the extract to 5.0 ~ 7.0, add 1-15% gelatin solution, egg white solution or other precipitant dropwise to complete the tannin precipitation. After conventional treatment, the tannin can be removed. And total organic acids of gold and silver of hemolytic saponins;

Alternatively, take honeysuckle or leaves and extract them according to conventional methods. The extraction solution is adsorbed with an adsorbent such as polymillamine, macroporous adsorption resin, silica gel, etc. After the impurities are washed away, the solvent is eluted with water, alkaline water, ethanol, or acrylic acid to obtain Remove the total organic acids of honeysuckle from tannins and blood saponins.

The invention is further illustrated by the following non-limiting examples.

Examples

Example 1 Preparation of baicalin

Take 1000g decoction of Scutellaria baicalensis and cook it twice with 10 times the amount of water. Combine the decoction and filter. When the temperature of the filtrate drops to 40, add concentrated hydrochloric acid dropwise to adjust the pH to 1.0, leave it to settle, and discard four-fifths. Supernatant, add 5 times the amount of distilled water to suspend, add 40% sodium hydroxide solution dropwise to adjust pH 7.5, filter, ultrafiltration at 0.1MP / cm ² pressure, molecular weight cut-off value of the ultrasonic membrane is 6000 -20000, the ultra filtrate was adjusted to pH 1.0 with concentrated hydrochloric acid, statically filtered, the precipitate was washed 3 times with distilled water, filtered with suction, and dried to obtain 70 _{g of} baicalin.

The above total baicalin was recrystallized from ethanol to obtain baicalin 58 _g .

Suspend the total glucosides of Scutellaria baicalensis or Scutellaria baicalensis with water for injection under sterile conditions, adjust ρΗ-^. Α o, filter, concentrate, dry, or pour the concentrated solution into ethanol to precipitate and precipitate Dry to obtain total baicalin or baicalin for injection.

Example 2 Preparation of total organic acids of honeysuckle

Take 1000g of honeysuckle medicinal material or honeysuckle leaf, extract 12 to 4 times with 12 times the amount of 60% ethanol, recover the solvent under reduced pressure, add water to make a 100% aqueous solution containing the medicinal material, and then extract with the same amount of n-butanol to recover from the extract Solvent, dried to obtain 76g of total honeysuckle organic acids.

The solvent was recovered from the n-butanol extract to 100% of the medicinal material, and extracted three times with an equivalent amount of 5% sodium bicarbonate aqueous solution. The alkaline aqueous solution was adjusted to pH 0-7.0, and the 3% gelatin solution was added dropwise to completely precipitate the tannin. , Standing, filtering, concentrating, and drying, so as to remove the total organic acids 5 of tannins and hemolytic saponins; or

Take 1000g of honeysuckle medicinal material or honeysuckle leaf, extract 12 to 4 times with 12 times the amount of 60% ethanol, recover the solvent under reduced pressure, adsorb with macroporous adsorption resin, wash away impurities with distilled water, and elute with ethanol to remove tan. Honeysuckle and Organic Hemolytic Saponin 85g.

10 g of the above total honeysuckle organic acids were added to a 1000 g silica gel G column and eluted with methanol: chloroform 1: 1 to obtain 0.2 g of chlorogenic acid and dicaffeine quinic acid O.lg.

Example 3 Preparation of total glycosides

Take 1000g of Forsythia medicinal materials or forsythia leaves and extract them 2 to 4 times with 10 times the amount of 70% ethanol. Combine the extracts and recover the solvent under reduced pressure to make a 100% extract aqueous solution containing medicinal materials. Alcohol extraction, the solvent was recovered from the extract, concentrated and dried to obtain 120g of forsythia glycosides.

The total forsythiaside was dissolved in water, and 3% gelatin solution was added dropwise to complete the tannin precipitation, and the solution was filtered. The filtrate was added dropwise with a saturated cholesterol alcohol solution to complete the precipitation of saponin, filtered, and the filtrate was concentrated and dried to obtain a refined product. 95g of forsythia glycosides for removing tanning shield and hemolytic saponins; or

10g of the total forsythiaside was dissolved in water, 800g of the macroporous adsorption resin was used for adsorption, and eluted with ethanol to obtain 6g of forsythia total glycosides, which were purified to remove tannins and hemolytic saponins. , Added to a 600g silica gel G column, and eluted with ethyl acetate-butyric acid-water 5: 3: 1: 1: to obtain forsythiaside 0.2g.

Example 4 aerosol and preparation method

Scutellaria Baicalensis Formula 200g Forsythia Suspension 220g

Honeysuckle Total Organic Acid 180g Span 85 500g

Ethyl oleate 500g dichlorodifluoromethane

Made into 1000 bottles, 14g each Method: The total glucosides of Scutellaria Baicalensis and total organic acids of honeysuckle are crushed according to the prescribed amount.

80-120 mesh sieve, then mix it with Span 85 and ethyl oleate, grind it into a paste, gradually add it to a colloid mill, grind it to a particle size of 10 nm at 1200 rpm, put it in a container, add a valve, and a cap. Press dichlorodifluoromethane to 14 grams per bottle and shake the hook to get an aerosol.

Example 5 suppository and preparation method

Scutellaria Baicalensis 180g

Honeysuckle Total Organic Acid 250g

Mixed fatty acid glycerin tincture (type 34) 750g

1000 pieces, 1.5g each

Method: Crush the total glucosides of Scutellaria baicalensis, total organic acids of honeysuckle and total glycosides of forsythia, pass through 80-120 mesh sieve, mix well, add to the suppository base that has been heated and melted, stir well, inject into the suppository mold and cool , Cutting, packaging, serving as suppositories.

Example 6: Tablets and preparation method

Total Scutellaria Baicalensis 18g Total Forsythia Suspension 24g Total Honeysuckle Organic Acid 18g

Cyclodextrin 90g powdered sugar 450g menthol 3g

Water tablets lg magnesium stearate 6g

Made into 1000 tablets, 0.6g each

Preparation method: Wrap total glucoside glycosides and cyclodextrin, mix with total cilantro ring, honeysuckle total organic acid, powdered sugar, make granules, spray into menthol and borneol ethanol solution, add magnesium stearate, mix Evenly, press the tablet to obtain a tablet.

Example 7 Capsule and preparation method

Scutellaria Baicalensis 18g

Honeysuckle total organic acid 200g acrylic resin

Made into 1000 capsules, each 0.25g

Production method: Forsythia total glycosides and honeysuckle total organic acids are made into granules by dry method, coated with acrylic resin film, and differently colored, mixed with baicalone total glycoside granules, and obtained in empty capsules.

Example 8 Granules and preparation method

Scutellaria Baicalensis Glycoside 110g Flatinol 190g

4 _g total organic acids honeysuckle cyclodextrin 6i, 0g 1000g, 4g per bag

Method: Wrapped 110g total glucosides with 690g cyclodextrin, mixed with forsythia total glycosides, honeysuckle total organic acids, stevioside and made into granules.

Example 9 Water injection, powder injection and preparation method

Scutellaria Baicalis 18g Forsythia Suspension 29g

Honeysuckle Total Organic Acid 22g

Made into 1000ml or 100 sticks (powder injection)

Preparation method: Dissolve total organic acids of honeysuckle and total forsythia glycosides with water for injection, adjust pH 5.0-7.0, filter, and add 3% gelatin solution dropwise to complete tannin precipitation, let stand, filter, and add saturated filtrate The bile alcohol solution completely precipitated the saponin, filtered, and the filtrate was added to the total scutellaria baicalensis to suspend. The sodium bicarbonate-sodium carbonate solution was used to adjust the pH to 6.-.5 to dissolve. After heating, refrigerating, filtering, ultrafiltration, etc., Encapsulation, sterilization, that is, 4 injections; or concentrated, dry, sterile packaging, to obtain powder injection.

Example 10 Water injection, powder injection and preparation method

Scutellaria Baicalensis 15g

Remove tannins and total forsythia glycosides 21g

Honeysuckle Total Organic Acids Removed Tannin and Hemolytic Soap Ring 19g

Made of 100

Preparation method: According to the prescription amount, refined forsythia total glycosides for removing tannin and hemolytic saponin, refined organic acids for removing tannin and hemolytic soap type honeysuckle are dissolved with water for injection, and added to the scutellaria baicalensis for suspension Add sodium bicarbonate-sodium arsenate dropwise to adjust the pH to 7.0-7.5 to dissolve. After heating, refrigerating, filtering or ultrafiltration, seal and sterilize to obtain the injection solution; or concentrate, dry, and sterilize Installed to get powder injection.

Example 11 Powder injection and preparation method

Scutellaria Baicalensis 15g

Forsythia Suspense 21g for removing tannins and hemolytic saponins

Honeysuckle Total Organic Acids Removed Tannin and Hemolytic Saponin 19g

Made of 100

Method: Suspension of Scutellaria baicalensis in distilled water according to the prescribed amount, with 40% sodium hydroxide

-6 The solution was adjusted to pH 7.0-8.0, concentrated; dried, or added with ethanol to precipitate the baicalin sodium salt, filtered off the precipitate, dried, and pulverized to obtain the baicalin total glucoside raw material for injection; the refined tannin and hemolytic properties were removed Total saponin forsythia glycosides, refined total organic acids of honeysuckle which remove tannins and hemolytic saponins are dissolved with water for injection. Sodium bicarbonate-sodium carbonate is adjusted to pH Η 7.0 to dissolve, and heated, refrigerated, filtered or ultra-filtered. After the treatment, it is concentrated, dried, and pulverized. It is divided into sterilized containers under sterile conditions, and then filled with sterile scutellaria baicalensis total glycosides, and sealed to obtain powder injections; or the above three components are measured separately. Content, aseptically aliquoted after mixing under aseptic conditions, and sealed to obtain a powder injection.

Example 12 Water injection, powder injection and preparation method

Baicalin 150g, Glucoside 200g

Chlorogenic acid 150g Dicaffeine Quinine 25g

Made into 1,000

Method: Suspend baicalin in distilled water according to the prescribed amount, adjust the pH to 7.0-8.0 with 40% sodium hydroxide solution, concentrate, dry, or add ethanol to precipitate the baicalin sodium salt, and filter the precipitate. Dry and pulverize to obtain the baicalin salt material for injection. Dissolve chlorogenic acid, dicaffeine quinic acid and dihydrogenin in water for injection, filter, and drop the filtrate to adjust the pH 6.5- 7.5, filter, concentrate, dry, pulverize, distribute into ampoules under sterile conditions, then load the baicalin salt, and seal to obtain the powder injection.

Example 13 Oral liquid and preparation method

Total glucosides of baicale 200g Total glycosides of forsythia 0.8g

Honeysuckle Total Organic Acid 80g White Granulated Sugar 80g

Sodium carbonate-sodium bicarbonate buffer

Made into 1000ml

Method: Dissolve total forsythia glucosides, total honeysuckle organic acids, and baicalone total glucosides in buffer according to the prescribed amount, filter, pot, sterilize, and obtain oral solution.

Example 14 Water injection and preparation method

Total baicalin for injection 200g

Forsythia glycosides tannins and hemolytic saponins removed 3.7g

Made into 1000ml

Preparation method: Dissolve ¾ total glycosides from which tannins and hemolytic saponins are removed, and add The total glucosides of baicale for injection were adjusted to pH 6.5-7.5 with a sodium bicarbonate solution. After conventional processing such as heating, refrigerating, potting and sterilization, water injection was obtained.

Example 15 powder injection and preparation method

Total Baicalin for injection 3.7g

Forsythia glycosides with tannins and hemolytic saponins removed 200 _g

Made of 100

Method: Dissolve the refined Forsythia suspensa with water for injection to remove tannin and hemolytic saponin according to the prescribed amount, add sodium bicarbonate solution dropwise to adjust pH 6.5-7.5, after conventional treatment, dry, pulverize, Under bacterial conditions, aliquot it into a sterilized container, and then fill it with total baicalin for injection and seal it to obtain a powder injection.

Example 16 Powder injection and preparation method

Total baicalin for injection 200g

Forsythiaside 300g for removing tannins and hemolytic saponins

Made of 100

Preparation method: Dissolve refined forsythia total glycosides for removing tannin and hemolytic saponin with water for injection, add sodium bicarbonate solution dropwise to adjust pH 6.5-7.5, after conventional treatment, dry, crush, and Under bacterial conditions, aliquoted into a sterilized container, and then filled with Scutellaria baicalensis for injection, sealed, to obtain a powder injection.

The pharmacodynamic test of the pharmaceutical composition of the present invention proves that the antibacterial effect is better than that of Shuanghuanglian preparation, and the anti-embedging virus effect is similar to that of Shuanghuanglian preparation. The test results are as follows:

1. Antibacterial effect:

The in-tube antibacterial test proves that the composition of the present invention has a strong antibacterial effect, and has an antibacterial effect on Streptococcus group A, pneumococcus, influenzae bacillus, dysentery bacillus, and Pseudomonas aeruginosa, which are 1 to 2 higher than the Shuanghuanglian preparation. Dilution. The experimental results are shown in Tables 1 and 2.

Table 1 Antibacterial test results of Shuanghuanglian preparation

Test tube number 1 2 3 4 5 6 7 8 9 10 Dilution 1: 4 1: 8 1:16 1:32 1:64 1: 128 1: 256 1: 512 1: 1024 0 Staphylococcus------ -+ + + Streptococcus---+ + + + + + + Pneumococcal ¾ a-+ + + + -4- + + Diphtheria-----+ + + + + + + Influenza + + + + + + + + + + E. Coli----+ + + + + + Pseudomonas Aeruginosa---+ + + + + + + Bacillus + + + + Shigella-+ + + + + + + + + Table 2 Antibacterial test results of the pharmaceutical composition of the present invention

Test tube number 1 2 3 4 5 6 7 8 9 10 Dilution 1: 4 1: 8 1:16 1:32 1:64 1: 128 1: 256 1: 512 1: 1024 0 Staphylococcus + + + + Streptococcus- --One + + + + + + Pneumococcus--One + + + + + + Diphtheria----+ + + + + Influenza-One + + + + + + + + E. coli--- -+ + + + + + Pseudomonas aeruginosa----+ + + + + + Bacillus + + + + Shigella-+ + + + + + + +

2. Antiviral effect:

The fine-tissue tissue culture method was used to observe its anti-respiratory syncytial virus effect, and the results proved that the pharmaceutical composition of the present invention has a significant anti-viral effect, and its intensity of action is similar to that of the Shuanghuanglian preparation. The results are shown in Table 3.

Table 3 Anti-combination! & Experimental observation of viral effects

Dilute 10 ¹ 10- ² 500X 10 ' ³ 5 仟 × ΚΓ 50,000 X blank lesion Shuanghuanglian preparation 100% 25%------The present invention 100% 25%

Degree Control group 75% 75% 75% 50% 50% 25%--

3. The pharmaceutical composition containing total scutellaria baicalensis and total forsythia glycosides and no total organic honeysuckle ^ has a slight weakened antibacterial effect, among which antibacterial action against diphtheria and bacillus -t. Contains gold and silver The pharmaceutical composition of total organic acids in flowers is similar, and the antibacterial effect on other strains is one dilution lower; the anti-syncytial virus effect is similar.

Claims

Rights request

1. An antibacterial and antiviral pharmaceutical composition comprising 0.02-98.18% of total glucosides of baicalein extracted from scutellaria baicalensis and 0.02-98.18% of total glycosides of forsythia radix from forsythia or forsythia leaves Contains 0.40-88.18% of the total organic acids of honeysuckle extracted from honeysuckle or honeysuckle leaves as active ingredients, and optionally contains pharmaceutical excipients.

2. The antibacterial and antiviral pharmaceutical composition according to claim 1, characterized in that when the oral ingredients, suppositories and aerosols are prepared in the active ingredient, the baicalin glycosides contain baicalin> 70%, forsythia The total glycosides contain forsythiaside> 10 ° /. , Total organic acids in honeysuckle contain chlorogenic acid> 10%; In the preparation of injection, total baicalin contains baicalin> 86%, forsythia total formula contains forsythiaside glycosides> 25%, total honeysuckle organic acid contains green Orthoacid> 25%.

3. A method for preparing an anti-vaccine antiviral pharmaceutical composition according to claim 1 or 2, the method comprising the following steps:

(i) Preparation of active ingredients:

(a) Preparation of baicalin glycosides: According to the conventional method, baicalin baicalin or baicalin is prepared for oral use; or the obtained baicalin baicalin or baicalin is suspended in water for injection under sterile conditions, and the pH is adjusted to 7.0- 8.0, filtering, concentrating, drying; or pouring the concentrated solution into ethanol to precipitate, and drying the precipitate, that is to obtain total baicalin or baicalein for injection ^;

(b) Preparation of total forsythiaside:

Take forsythia or forsythia leaves, extract them according to conventional methods, and concentrate them with organic solvents such as n-butanol. After conventional treatment, forsythia can be used in oral preparations, aerosols, suppositories, etc .; Dissolve, add 1-15% gelatin solution, egg white solution or other precipitants dropwise to complete the tannin precipitation, let it stand, filter, and add the saturated bile alcohol solution or other precipitants dropwise to complete the precipitation of saponins. After conventional treatment, That is to obtain refined forsythia glycosides that remove tannins and hemolytic saponins; or, take forsythia or forsythia leaves and extract them according to conventional methods, and extract the solution with adsorbents such as polyamine, macroporous adsorption resin, silica gel, etc. After the impurities are washed away, the solvents such as water, ethanol, propidium, ethyl acetate and the like are used to elute the tannin and hemolytic saponin.

If necessary, (c) Preparation of total organic acids of honeysuckle:

Take honeysuckle or leaves, extract them by conventional methods, and concentrate them with organic solvents such as n-butanol Take, after conventional processing, to obtain raw materials for oral preparations, aerosols, suppositories; the above-mentioned n-butanol extract is extracted with sodium bicarbonate-sodium hydrogen phosphate or a buffer solution of pH 7.0 ~ 8.0, the extract is adjusted ρΗ5. 0 ~ 7.0, add 1 ~ 15% of gelatin solution, egg white solution or other precipitant dropwise to complete the tannin precipitation, and after conventional treatment, the total organic acids of honeysuckle of tannin and hemolytic soap can be removed; or, take the honeysuckle Or leaves, extracted according to conventional methods, the extract is adsorbed with an adsorbent such as polyamide, macroporous adsorption resin, silica gel, etc. After the impurities are washed away, the solvent is eluted with water, alkaline water, ethanol, propylene, etc. Total organic acids of honeysuckle with hemolytic saponins;

If necessary, (ii) mix the above active ingredients with excipients.