CN109954067A - A kind of compound formula chinaroot greenbrier granules new preparation process - Google Patents

A kind of compound formula chinaroot greenbrier granules new preparation process Download PDF

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CN109954067A
CN109954067A CN201910140033.9A CN201910140033A CN109954067A CN 109954067 A CN109954067 A CN 109954067A CN 201910140033 A CN201910140033 A CN 201910140033A CN 109954067 A CN109954067 A CN 109954067A
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compound formula
chinaroot greenbrier
granules
chinaroot
portions
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朱立华
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HUNAN TRADITIONAL CHINESE MEDICINE INSTITUTE
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HUNAN TRADITIONAL CHINESE MEDICINE INSTITUTE
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    • A61K36/185—Magnoliopsida (dicotyledons)
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Abstract

The invention discloses a kind of new preparation process of compound formula chinaroot greenbrier granules.Compound formula chinaroot greenbrier medicinal material is extracted using decompression low-temperature boiling extraction process in the present invention, extracted, resulting thick paste is concentrated is prepared particle through one-step palletizing technology again.It is excessive that preparation method of the invention not only solves supplementary product consumption in existing compound formula chinaroot greenbrier granules preparation process, the defects of finished product yield is lower, and depressurize low temperature and extract the recovery rate for increasing effective component, have many advantages, such as that easy to operate, process, quality are stablized.

Description

A kind of compound formula chinaroot greenbrier granules new preparation process
Technical field
The present invention relates to Chinese patent drug preparation field, specifically compound formula chinaroot greenbrier granules extracting method and preparation method thereof changes Into.
Background technique
Compound formula chinaroot greenbrier granules are the exclusive listing kind that the independent research of Guo Hua pharmaceutical Co. Ltd has intellectual property, Fang Zhong The rules for the treatment of for following compound of Chinese herbal medicine tumour are made of clearing heat and detoxicating chinaroot greenbrier, cordate houttuynia etc.；The radix ranunculi ternati of resolving hard lump, soil The composition such as soft-shelled turtle worm；Enriching yin boost qi is made of fructus lycii, fresh snakehead etc..It is and patented: compound formula chinaroot greenbrier granules and its preparation Method ZL200410046614.X.
Compound formula chinaroot greenbrier granules are conventionally produced to be had the following problems:
(1) extraction process of original process is to make fluid temperature reach 100 DEG C of boilings under steam heating normal pressure to generate reflux, Chemical component is more easily damaged in extraction process, is unfavorable for the traditional Chinese medicine extraction of the effective component containing thermal sensitivity.
(2) compound formula chinaroot greenbrier water cooking liquid is rich in saponin(e, polysaccharide component, because rich in thick paste when being concentrated under reduced pressure in actual production A large amount of bubble can be generated containing saponin(e, polysaccharide component, time-consuming, causes to be concentrated and dried extremely difficult.
(3) granulating process of original process uses wet granulation, with waving after compound formula chinaroot greenbrier thick paste, starch and cane sugar powder mixing Granulator granulation.Auxiliary material sucrose melting is good, therefore supplementary product consumption is big.A large amount of intake sucrose easily induce children obesity and saprodontia.
(3) granulating process of original process will can just produce qualified by processes such as softwood processed, granulation, drying and whole grains Grain, process is various, and production efficiency is low, is not suitable for growing selling market and needs to want with the epoch of energy-saving consumption-reducing low-carbon environment-friendly It asks.
Summary of the invention
For compound formula chinaroot greenbrier granules traditional mode of production the problem of, the present invention proposes a kind of production of compound formula chinaroot greenbrier granules Improvement technique, improve compound formula chinaroot greenbrier granules prescription medicine in effective component recovery rate, reduce pelletization in auxiliary material use Amount, and production process is shortened, further decrease production cost and production time-consuming.In order to achieve the above object, the present invention passes through Following technical scheme is achieved.
A kind of preparation method of compound formula chinaroot greenbrier granules, which is characterized in that sequentially include the following steps:
1, thick paste is prepared
(1) decompression low-temperature boiling extracts: chinaroot greenbrier is weighed by prescription disclosed in compound formula chinaroot greenbrier granules, cordate houttuynia, and radix ranunculi ternati, Ground bettle, tussilago, fructus lycii, jujube, fresh snakehead taste medicinal material are placed in decompression extraction element, 6~8 times of amount distilled water are added, It vacuumizes heating low-temperature boiling to extract 2 times, each 1h~3h, merge after extracting solution filtering.
(2) be concentrated: extracting filtrate to double effect concentration tank, control vacuum degree is -0.05~-0.07MPa, 80 DEG C of extracting solution with Under to be concentrated into relative density be 1.05~1.15 (60 DEG C survey), obtain compound formula chinaroot greenbrier thick paste.
2, it pelletizes
(1) auxiliary material preheats: pouring into the boxcar of one-step-granulating method, opens after weighing dextrin and beta-cyclodextrin in prescription ratio It opens blower and heats, dextrin and beta-cyclodextrin is made to be uniformly heating to 70 DEG C under fluidized state.
(2) one-step palletizing: opening spraying button, sprays into adhesive, and adhesive relative density is 1.05~1.15, feed liquor speed 20 revs/min~30 revs/min, air inducing frequency 30Hz~40Hz of degree, close observation goods fluid state, until adhesive is whole It sprays into, inlet air temperature is constant, dries to water content less than 5%, cooling discharge.
The present invention has the following advantages compared with compound formula chinaroot greenbrier granules current process:
(1) it is extracted using decompression boiling, the recovery rate of medicinal material effective component increases.Since the boiling point of solvent is with ambient atmosphere The reduction of pressure and reduce, decompression boiling extraction makes at a lower temperature solution be in fluidized state progress Dynamic Extraction, so both It can guarantee that the heat-sensitive ingredients in medicinal material are decocted from high temperature to destroy, while reduce many big molecular impurities such as starch, tan Acid, the precipitation of viscous matter, convenient for the molding and stabilization of granulation.
(2) relative density of thick paste is 1.05~1.15 during one-step palletizing, than used in wet granulation in original process Thick paste relative density is small, therefore the time-consuming shortening of thick paste concentration.
(3) supplementary product consumption is reduced.Clear cream made from one prescription medicine of original prescription need to add 600g sucrose, 250g starch to be made Compound formula chinaroot greenbrier granules.Clear cream made from one prescription medicine of auxiliary material is done using one-step palletizing dextrin, beta-cyclodextrin in the present invention Only need 400g auxiliary material that compound formula chinaroot greenbrier granules can be made.Supplementary product consumption halves in manufactured particle, and active principle content doubles.It can Lower patient day dosing, sucrose, the starch in original process, therefore manufactured compound in the present invention are replaced with dextrin, beta-cyclodextrin Chinaroot greenbrier particle is Sugarless type product, reduces children and suffers from fat and saprodontia risk.
(4) production efficiency is improved.Using one-step palletizing technique, dry and one step of granulation is completed, and significantly improves compound formula chinaroot greenbrier The production efficiency of particle.And drying temperature is low, and speed is fast, is effectively protected the effective component of drug, compound greenbrier obtained Chinaroot greenbrier particle, drug ingedient is stable and content is uniform, good fluidity, and stable product quality is good.The dust generated in production process Few, technique is easily-controllable.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present invention, Technical scheme in the embodiment of the invention is clearly and completely described.Described embodiment is that a part of the invention is real Example is applied, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not making creation Property labour under the premise of every other embodiment obtained, shall fall within the protection scope of the present invention.
Embodiment 1
A kind of preparation method of compound granular, sequentially includes the following steps:
Prescription: 450g chinaroot greenbrier, 450g cordate houttuynia, 450g radix ranunculi ternati, 150g ground bettle, 150g tussilago, 450g fructus lycii, 450g jujube, the fresh snakehead of 270g.
(1) decompression boiling extracts: weighing eight taste medicinal materials in prescription ratio, is placed in decompression extraction element, is evacuated to body It is absolute pressure is -0.06MPa, 75 DEG C of heating low-temperature boilings extract, and 8 times of amount distilled water extraction 2h are added for the 1st time, add for the 2nd time Enter 6 times of amount distilled water 1.5h, merges after extracting solution filtering.
(2) it is concentrated: extracting filtrate to double effect concentration tank, control vacuum degree is -0.05MPa, and 70 DEG C of extracting solution are concentrated into one Fixed density (60 DEG C of surveys), obtains compound formula chinaroot greenbrier thick paste, sets spare in aerosol can.
(3) auxiliary material preheats: weighing 3500g dextrin, 500g beta-cyclodextrin, pours into the boxcar of one-step-granulating method, opens Blower simultaneously heats, and material is made to be uniformly heating to 70 DEG C under fluidized state.
(4) one-step palletizing: L9 (3 is used4) orthogonal trial table, carry out one-step palletizing conceptual design.It is carried out by table 1, table 2 Test.Test result is shown in Table 2.One-step-granulating method is opened, 70 DEG C of inlet air temperature, sprays into slurry, after material spray, inlet air temperature It is constant, it dries to water content less than 5%, cooling discharge.Re-sieving, 10 meshes can be passed through and cannot pass through of 80 meshes by collecting Grain is conforming particle.
Table 1: one-step palletizing experimental factor water-glass
Table 2: one-step palletizing experimental design and result (n=2)
Particle qualification rate %=conforming particle weight × 100%/theoretical weight, theoretical weight=10kg.
Test result analysis, intuitive analytical factor primary and secondary are determined by very poor size, it is seen that in three influence factors of investigation In, the influence sequence to compound granular yield are as follows: A > C > B, optimal process conditions are A2B3C2, charging rate 25r/min, Air inducing frequency is 40Hz, and thick paste relative density is 1.10.
Embodiment 2
The present embodiment is verified to 1 optimal processing parameter income of embodiment.
Prescription: 450g chinaroot greenbrier, 450g cordate houttuynia, 450g radix ranunculi ternati, 150g ground bettle, 150g tussilago, 450g fructus lycii, 450g jujube, the fresh snakehead of 270g.
(1) decompression boiling extracts: weighing eight taste medicinal materials by prescription, is placed in decompression extraction element, it is exhausted to be evacuated to system It is -0.06MPa to pressure, 75 DEG C of heating low-temperature boilings extract, and 8 times of amount distilled water of the 1st addition extract 2h, the 2nd 6 times of addition Distilled water 1.5h is measured, is merged after extracting solution filtering.
(2) it is concentrated: extracting filtrate to double effect concentration tank, control vacuum degree is -0.05MPa, and 70 DEG C are concentrated into relative density For 1.10 (60 DEG C of surveys), compound formula chinaroot greenbrier thick paste is obtained, is set spare in aerosol can.
(3) auxiliary material preheats: weighing 3500g dextrin, 500g beta-cyclodextrin, pours into the boxcar of one-step-granulating method, opens Blower simultaneously heats, and dextrin is made to be uniformly heating to 70 DEG C under fluidized state.
(5) one-step palletizing: opening spraying button, sprays into adhesive, 25 revs/min of peristaltic pump feed speed, removes wet temp 72 DEG C, 70 DEG C of inlet air temperature, air inducing frequency 40Hz, close observation goods fluid state, until binder all sprays into, material spray knot Shu Hou, inlet air temperature is constant, dries to water content less than 5%, cooling discharge.Re-sieving, collection can pass through 10 meshes and cannot It is conforming particle by the particle of 80 meshes.
Child speen supporting particle obtained by technique in embodiment 2 by optimization is helped with the children that original process are prepared Spleen particle carries out quality versus, and the detection method of projects is issued according to the national drug standards of State Food and Drug Administration Cloth member (standard label: WS-5334 (B-0334) -2014Z) is detected.
Quality measurements are as shown in table 3:
The comparison of 3 Quality Checkout Data of table
It in the present invention, is extracted using decompression boiling, granulation auxiliary material uses dextrin, beta-cyclodextrin, and granulating process uses one Step granulation.Compound formula chinaroot greenbrier granules made from technique and compound formula chinaroot greenbrier granules quality versus made of original process, identify in the present invention Item and check item do not have notable difference, and auxiliary material halves, and the content of nitrogen pool increases by twice in particle.
It is extracted using decompression boiling, Extracting temperature reduces, and can both guarantee that the heat-sensitive ingredients in compound formula chinaroot greenbrier medicinal material were exempted from It decocts and destroys by high temperature, while reducing many big molecular impurities such as starch, tannic acid, the precipitation of viscous matter, medicinal material effective component Recovery rate increase.
Auxiliary material is done with dextrin, beta-cyclodextrin in the present invention, supplementary product consumption halves in manufactured particle, and active principle content increases Add.Patient day dosing can be lowered, sucrose, the starch in original process, manufactured compound formula chinaroot greenbrier granules are replaced with dextrin, beta-cyclodextrin For Sugarless type product, reduces children and suffer from fat and saprodontia risk.
In one-step palletizing technique, dry and granulation is synchronously completed, and significantly improves the production efficiency of compound formula chinaroot greenbrier granules.And Drying temperature is low, and speed is fast, is effectively protected the effective component of drug.Adhesive is uniformly mixed with auxiliary material, compound obtained Chinaroot greenbrier particle, drug ingedient is stable and content is uniform, good fluidity, and stable product quality is good.The powder generated in production process Dirt is few.

Claims (6)

1. a kind of new preparation process of compound formula chinaroot greenbrier granules, which is characterized in that include the following steps
(1) decompression boiling extracts: chinaroot greenbrier is weighed by prescription disclosed in compound formula chinaroot greenbrier granules, cordate houttuynia, and radix ranunculi ternati, ground bettle, Tussilago, fructus lycii, jujube, fresh snakehead taste medicinal material are placed in decompression extraction element, 6~8 times of amount distilled water are added, vacuumize It heats low-temperature boiling to extract 2 times, each 1h~3h, merge after extracting solution filtering.
(2) it is concentrated: extracting filtered extracting solution into double effect concentration tank, extracting solution is concentrated control vacuum degree, sets aerosol can In it is spare.
(3) it prepares particle: a certain amount of auxiliary material (dextrin, beta-cyclodextrin) is put into one-step-granulating method hopper, open machine, preheating Auxiliary material is sprayed into thick original text with spray pattern when intake air temperature is 60~80 DEG C, and after material spray, inlet air temperature is constant, is done Dry particle is to water content less than 5%.Cooling discharge, sieving are packed to get compound formula chinaroot greenbrier granules.
2. compound formula chinaroot greenbrier granules preparation method according to claim 1, which is characterized in that according to place in the step (1) Square gauge determines the weight ratio of eight taste medicinal materials are as follows: 450 portions of chinaroot greenbriers, 450 portions of cordate houttuynias, and 450 portions of radix ranunculi ternatis, 150 portions of ground bettles, 150 parts Tussilago, 450 portions of fructus lyciis, 450 portions of jujubes, 270 parts of fresh snakeheads.
3. compound formula chinaroot greenbrier granules preparation method according to claim 1, which is characterized in that decompression mentions in the step (1) It takes, it is -0.05MPa~-0.07MPa that machine, which is evacuated to system absolute pressure,.Heating temperature is 60 in the low temperature extraction DEG C~80 DEG C.
4. compound formula chinaroot greenbrier granules preparation method according to claim 1, which is characterized in that mentioned twice in the step (1) It takes, the 1st 1h~2h, the 2nd 1.5h~2.5h.
5. compound formula chinaroot greenbrier granules preparation method according to claim 1, which is characterized in that filtrate is dense in the step (2) Contracting uses reduced pressure control vacuum degree for -0.05MPa~-0.08MPa, and thickening temperature is 60 DEG C~80 DEG C, is concentrated to give thick paste Relative density be 1.05~1.15 (60 DEG C survey).
6. compound formula chinaroot greenbrier granules preparation method according to claim 1, which is characterized in that dextrin is in the step (3) 300 parts~350 parts, 100 parts~50 parts of beta-cyclodextrin, air inducing frequency 30Hz~40Hz, 60 DEG C~80 DEG C of inlet air temperature, peristaltic pump 20 revs/min~30 revs/min of feed speed.
CN201910140033.9A 2019-02-26 2019-02-26 A kind of compound formula chinaroot greenbrier granules new preparation process Withdrawn CN109954067A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1596965A (en) * 2004-07-30 2005-03-23 单建华 Compound formula chinaroot greenbrier granules and its preparation method
CN108926619A (en) * 2018-09-04 2018-12-04 湖南时代阳光药业股份有限公司 A kind of preparation method of child speen supporting particle
CN109187820A (en) * 2018-11-09 2019-01-11 湖南国华制药有限公司 The method for building up and its finger-print of a kind of compound formula chinaroot greenbrier granules UPLC finger-print and application

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1596965A (en) * 2004-07-30 2005-03-23 单建华 Compound formula chinaroot greenbrier granules and its preparation method
CN108926619A (en) * 2018-09-04 2018-12-04 湖南时代阳光药业股份有限公司 A kind of preparation method of child speen supporting particle
CN109187820A (en) * 2018-11-09 2019-01-11 湖南国华制药有限公司 The method for building up and its finger-print of a kind of compound formula chinaroot greenbrier granules UPLC finger-print and application

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Application publication date: 20190702