CN103494957A - Preparation method of Jinma Gantai preparation for treating hepatitis - Google Patents

Preparation method of Jinma Gantai preparation for treating hepatitis Download PDF

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CN103494957A
CN103494957A CN201310455826.2A CN201310455826A CN103494957A CN 103494957 A CN103494957 A CN 103494957A CN 201310455826 A CN201310455826 A CN 201310455826A CN 103494957 A CN103494957 A CN 103494957A
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邬建明
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Mingyuan Pharmaceutical Co ltd
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Abstract

The invention relates to a preparation method of a Jinma Gantai preparation for treating hepatitis, belonging to the technical field of traditional Chinese medicines. The product is prepared from dichondra repens, berchemia lineate and the like and is prepared into pharmaceutically allowable dosage forms. The preparation has good stability and high bioavailability, is convenient to take, has beautiful and clean appearance and is easy to accept by the patients. The provided preparation method can be used for effectively preparing the needed preparation and ensuring that the production process of the prepared preparation is scientific and reasonable.

Description

A kind of preparation method for the treatment of the safe preparation of Golden Horse liver of hepatitis
Technical field
The present invention is a kind of preparation method for the treatment of the safe preparation of Golden Horse liver of hepatitis, belongs to the technical field of Chinese medicine.
Technical background
Hepatitis, by state of an illness weight, can be divided into plain edition hepatitis and hepatitis gravis; With its course of disease length, can be divided into acute hepatitis and chronic hepatitis.Primary disease belongs to the category of the diseases such as the traditional Chinese medical science " jaundice ", " costalgia ", " fulminant jaundice ", " acute jaundice ".Learn angle from tcm causa morbi and analyze, damp and hot is the Basic disease cause of primary disease, and runs through the course of disease all the time.The safe granule of Golden Horse liver is made by Herba Dichodrae, Radix berchemiae lineatae, Herba Verbenae, Radix Stephaniae Tetrandrae, Herba Patriniae, Herba Epimedii, the Radix Astragali, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae; The effect heat-clearing and toxic substances removing, invigorating spleen to remove dampness, blood circulation promoting and blood stasis dispelling; For dampness-heat in the liver and gallbladder, the acute hepatitis, chronic hepatitis of caused by energy stagnation and blood stasis.Existing product adopts the technique of WS-10313 (ZD-0313)-2002-2012Z record, and the method simple coarse, cause active constituent content on the low side, affects the treatment.
So in view of such circumstances, providing a kind of rational preparation method is to be badly in need of the thing solved.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation method.
Technical scheme of the present invention is to form like this:
A kind of Chinese medicine preparation is by Herba Dichodrae 288.2g, Radix berchemiae lineatae 153.3g, Herba Verbenae 115g, Radix Stephaniae Tetrandrae 191.6g, Herba Patriniae 115g, Herba Epimedii 153.3g, Radix Astragali 153.3g, Radix Paeoniae Rubra 153.3g, Radix Salviae Miltiorrhizae 230 and adjuvant are prepared from as follows: the thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, when decompression and solvent recovery is 50-60 ℃ to relative density, the thick paste of 1.34-1.40 adds adjuvant, make oral formulations.Described oral formulations refers to capsule, granule, tablet.
Specifically: the thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste of 1.34-1.40 when decompression and solvent recovery is 50-60 ℃ to relative density, add 4 times of amount sucrose, mix homogeneously, granulate, dry, granulate obtains granule.
The thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste of 1.34-1.40 when decompression and solvent recovery is 50-60 ℃ to relative density, drying under reduced pressure, pulverize, the magnesium stearate that adds appropriate amount of starch and 0.2%, mix homogeneously, fill, obtain capsule.
The thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste of 1.34-1.40 when decompression and solvent recovery is 50-60 ℃ to relative density, drying under reduced pressure, pulverize, add in right amount and can press starch, mix homogeneously, tabletting obtains tablet.
Experimental example:
1. optimization for extracting condition
The extraction ratio of peoniflorin of take is performance assessment criteria, adopts the orthogonal experiment of four factor three levels, optimizes the impact on the extraction ratio of peoniflorin of screening amount of water (A), extraction time (B) and extraction time (C), and the factor level table is as follows:
Figure BSA0000095752640000021
Determine that through optimizing screening best extraction conditions is: A 1b 2c 2, with 6 times of water gagings, decoct 2 times each 1.5 hours; Carry out the parallel verified test as condition, result of the test is as follows:
Figure BSA0000095752640000022
From top test, can find out, stable through the extraction conditions of screening.
2. purification condition optimization
Extract preparation: take each medical material, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), is divided into 2 parts, carry out purification with distinct methods respectively, investigate the impact of purification condition on the effective ingredient rate of transform.
Method one: clear paste is cooled to room temperature, adds 2 times of amount ethanol, stir, place 48 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.34~1.40 (50~60 ℃), drying under reduced pressure is measured content.
Method two: clear paste is cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3~4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9~10 that water liquid is regulated pH with ammonia, adds the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste that decompression and solvent recovery to relative density is 1.34~1.40 (50~60 ℃), drying under reduced pressure, measure content.
Figure BSA0000095752640000031
From top active constituent content, can find out, the purification effect of purification process two ratio method one is good.
3. the impact of different process route on the product drug effect
Because the chemical composition of different process route enrichments is distinguished to some extent, still the technique after screening and other preparation technology commonly used are carried out to the pharmacology curative effect relatively, sample preparation and therapeutic evaluation result are as follows:
Sample 1: take each medical material, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, and filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (90~95 ℃), clear paste is cooled to room temperature, add 2 times of amount ethanol, stir, place 48 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.34~1.40 (50~60 ℃), drying under reduced pressure.
Sample 2: take each medical material, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3~4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9~10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste that decompression and solvent recovery to relative density is 1.34~1.40 (50~60 ℃), drying under reduced pressure.
Sample 3: get Herba Epimedii, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra and Radix Stephaniae Tetrandrae and mix, add 8 times of amount 70% alcohol reflux 2 times, each 1 hour, extracting liquid filtering, filtrate recycling ethanol is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), is cooled to room temperature, add 2 times of water gagings, stir, filter, filtrate is concentrated into the thick paste that relative density is 1.34~1.40 (50~60 ℃); The residue medical material adds 6 times of decoctings to boil 2 times, and each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), is cooled to room temperature, adds 2 times of amount ethanol, stir, place 48 hours, filter, filtrate recycling ethanol is concentrated into the thick paste that relative density is 1.34~1.40 (50~60 ℃), thick paste and above-mentioned alcohol extraction thick paste merge, drying under reduced pressure.
Protective effect research to D mono-aminogalactose acute liver: by tested mice, random packet, 10 every group.D mono-aminogalactose amine model group: press Mouse Weight 20mL/kg distilled water gavage.Sample sets: press 2g/kg gavage respectively.Matched group: 20mL/kg distilled water gavage.The continuous gastric infusion 3d of each treated animal, every day 1 time, 1h after the 4th day gastric infusion, except matched group, all the other 4 treated animals are through the D of lumbar injection 100g/L mono-aminogalactose amine 500g/kg.Continue gastric infusion, put to death animal after 24h and get blood, centrifugal, get serum, automatic clinical chemistry analyzer detects.
Figure BSA0000095752640000041
This experiment is by lumbar injection D-GlaN, observed sample prepared by the different process impact on the D-G1aN liver injury model.Result shows, the application's technique (2 groups, sample) can effective rich active ingredient, improved the curative effect of product.
Concrete embodiment
Embodiment 1: Herba Dichodrae 288.2g, Radix berchemiae lineatae 153.3g, Herba Verbenae 115g, Radix Stephaniae Tetrandrae 191.6g, Herba Patriniae 115g, Herba Epimedii 153.3g, Radix Astragali 153.3g, Radix Paeoniae Rubra 153.3g, Radix Salviae Miltiorrhizae 230g
Above nine flavor medical materials, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3~4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9~10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste that decompression and solvent recovery to relative density is 1.34~1.40 (50~60 ℃), add 4 times of amount sucrose, mix homogeneously, granulate, dry, granulate obtains granule, boiled water is taken after mixing it with water, a 10g, 3 times on the one.
Embodiment 2: Herba Dichodrae 288.2g, Radix berchemiae lineatae 153.3g, Herba Verbenae 115g, Radix Stephaniae Tetrandrae 191.6g, Herba Patriniae 115g, Herba Epimedii 153.3g, Radix Astragali 153.3g, Radix Paeoniae Rubra 153.3g, Radix Salviae Miltiorrhizae 230g
Above nine flavor medical materials, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3~4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9~10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste that decompression and solvent recovery to relative density is 1.34~1.40 (50~60 ℃), drying under reduced pressure, pulverize, the magnesium stearate that adds appropriate amount of starch and 0.2%, mix homogeneously, fill, obtain capsule.
Embodiment 3: Herba Dichodrae 288.2g, Radix berchemiae lineatae 153.3g, Herba Verbenae 115g, Radix Stephaniae Tetrandrae 191.6g, Herba Patriniae 115g, Herba Epimedii 153.3g, Radix Astragali 153.3g, Radix Paeoniae Rubra 153.3g, Radix Salviae Miltiorrhizae 230g
Above nine flavor medical materials, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3~4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9~10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste that decompression and solvent recovery to relative density is 1.34~1.40 (50~60 ℃), drying under reduced pressure, pulverize, add in right amount and can press starch, mix homogeneously, tabletting obtains tablet.
Embodiment 4 Herba Dichodrae 288.2g, Radix berchemiae lineatae 153.3g, Herba Verbenae 115g, Radix Stephaniae Tetrandrae 191.6g, Herba Patriniae 115g, Herba Epimedii 153.3g, Radix Astragali 153.3g, Radix Paeoniae Rubra 153.3g, Radix Salviae Miltiorrhizae 230g
Getting Herba Epimedii, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra and Radix Stephaniae Tetrandrae mixes, add 8 times of amount 70% alcohol reflux 2 times, each 1 hour, extracting liquid filtering, filtrate recycling ethanol is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), is cooled to room temperature, add 2 times of water gagings, stir, filter, filtrate is concentrated into the thick paste that relative density is 1.34~1.40 (50~60 ℃); The residue medical material adds 6 times of decoctings to boil 2 times, and each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.14~1.16 (70~75 ℃), is cooled to room temperature, add 2 times of amount ethanol, stir, place 48 hours, filter, filtrate recycling ethanol is concentrated into the thick paste that relative density is 1.34~1.40 (50~60 ℃), and thick paste and above-mentioned alcohol extraction thick paste merge, mix, add 4 times of amount sucrose, granulate, dry, granulate, obtain granule.

Claims (5)

1. the preparation method of the safe preparation of the Golden Horse liver for the treatment of hepatitis, it is characterized in that: it is by Herba Dichodrae 288.2g, Radix berchemiae lineatae 153.3g, Herba Verbenae 115g, Radix Stephaniae Tetrandrae 191.6g, Herba Patriniae 115g, Herba Epimedii 153.3g, Radix Astragali 153.3g, Radix Paeoniae Rubra 153.3g, Radix Salviae Miltiorrhizae 230 and adjuvant are prepared from as follows: the thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, when decompression and solvent recovery is 50-60 ℃ to relative density, the thick paste of 1.34-1.40 adds adjuvant, make oral formulations.
2. according to the preparation method of the safe preparation of the Golden Horse liver for the treatment of hepatitis claimed in claim 1, it is characterized in that: described oral formulations refers to capsule, granule, tablet.
3. according to the preparation method of the safe preparation of the Golden Horse liver for the treatment of hepatitis claimed in claim 2, it is characterized in that: the thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste of 1.34-1.40 when decompression and solvent recovery is 50-60 ℃ to relative density, add 4 times of amount sucrose, mix homogeneously, granulate, dry, granulate obtains granule.
4. according to the preparation method of the safe preparation of the Golden Horse liver for the treatment of hepatitis claimed in claim 2, it is characterized in that: the thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste of 1.34-1.40 when decompression and solvent recovery is 50-60 ℃ to relative density, drying under reduced pressure, pulverize, the magnesium stearate that adds appropriate amount of starch and 0.2%, mix homogeneously, fill, obtain capsule.
5. according to the preparation method of the safe preparation of the Golden Horse liver for the treatment of hepatitis claimed in claim 2, it is characterized in that: the thing of getting it filled, add 6 times of decoctings to boil 2 times, each 1.5 hours, collecting decoction, filter, the clear paste of 1.14-1.16 when filtrate is concentrated into relative density and is 70-75 ℃, be cooled to room temperature, add the equivalent n-butanol extraction 2 times, merge n-butyl alcohol liquid, water liquid salt adding acid for adjusting pH is 3-4, add the equivalent n-butanol extraction 2 times, merge butanol solution, it is 9-10 that water liquid is regulated pH with ammonia, add the equivalent n-butanol extraction 2 times, merge all n-butyl alcohol liquid, the thick paste of 1.34-1.40 when decompression and solvent recovery is 50-60 ℃ to relative density, drying under reduced pressure, pulverize, add in right amount and can press starch, mix homogeneously, tabletting obtains tablet.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108718931A (en) * 2018-04-25 2018-11-02 覃福裕 The artificial cultivation method of dewdrop grass

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CN102813752A (en) * 2012-09-05 2012-12-12 贵州百花医药股份有限公司 Preparation method of creeping dichondra-berchemia lineata-verbena Gantai preparation

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CN108718931A (en) * 2018-04-25 2018-11-02 覃福裕 The artificial cultivation method of dewdrop grass

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