CN104510813B - A kind of preparation method of heart maitong capsule - Google Patents
A kind of preparation method of heart maitong capsule Download PDFInfo
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- CN104510813B CN104510813B CN201510011589.XA CN201510011589A CN104510813B CN 104510813 B CN104510813 B CN 104510813B CN 201510011589 A CN201510011589 A CN 201510011589A CN 104510813 B CN104510813 B CN 104510813B
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- 239000002775 capsule Substances 0.000 title claims abstract description 35
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 93
- 239000000843 powder Substances 0.000 claims abstract description 55
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 55
- 239000000706 filtrate Substances 0.000 claims abstract description 44
- 150000001875 compounds Chemical class 0.000 claims abstract description 30
- 241000219784 Sophora Species 0.000 claims abstract description 25
- 244000131316 Panax pseudoginseng Species 0.000 claims abstract description 23
- 235000003181 Panax pseudoginseng Nutrition 0.000 claims abstract description 23
- 240000007164 Salvia officinalis Species 0.000 claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 22
- 235000005412 red sage Nutrition 0.000 claims abstract description 22
- 238000000605 extraction Methods 0.000 claims abstract description 19
- 239000000284 extract Substances 0.000 claims abstract description 17
- 239000006228 supernatant Substances 0.000 claims abstract description 15
- 238000004064 recycling Methods 0.000 claims abstract description 12
- 239000003814 drug Substances 0.000 claims abstract description 10
- 241000427159 Achyranthes Species 0.000 claims abstract description 8
- 235000003365 Ilex pubescens Nutrition 0.000 claims abstract description 8
- 241001100932 Ilex pubescens Species 0.000 claims abstract description 8
- 244000179560 Prunella vulgaris Species 0.000 claims abstract description 8
- 235000008113 selfheal Nutrition 0.000 claims abstract description 8
- 244000037364 Cinnamomum aromaticum Species 0.000 claims abstract description 7
- 235000014489 Cinnamomum aromaticum Nutrition 0.000 claims abstract description 7
- 238000002156 mixing Methods 0.000 claims abstract description 3
- 238000001914 filtration Methods 0.000 claims description 24
- 238000001035 drying Methods 0.000 claims description 7
- 206010013786 Dry skin Diseases 0.000 claims description 3
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims description 3
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 22
- 238000005516 engineering process Methods 0.000 description 20
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- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 12
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 12
- 235000003143 Panax notoginseng Nutrition 0.000 description 12
- 241000180649 Panax notoginseng Species 0.000 description 12
- 229920002472 Starch Polymers 0.000 description 12
- 238000009835 boiling Methods 0.000 description 12
- 239000000920 calcium hydroxide Substances 0.000 description 12
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- 235000019359 magnesium stearate Nutrition 0.000 description 11
- 229920003139 Eudragit® L 100 Polymers 0.000 description 10
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 10
- 239000007788 liquid Substances 0.000 description 9
- 229920001353 Dextrin Polymers 0.000 description 8
- 239000004375 Dextrin Substances 0.000 description 8
- 235000019425 dextrin Nutrition 0.000 description 8
- 238000004821 distillation Methods 0.000 description 8
- JMGZEFIQIZZSBH-UHFFFAOYSA-N Bioquercetin Natural products CC1OC(OCC(O)C2OC(OC3=C(Oc4cc(O)cc(O)c4C3=O)c5ccc(O)c(O)c5)C(O)C2O)C(O)C(O)C1O JMGZEFIQIZZSBH-UHFFFAOYSA-N 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- IVTMALDHFAHOGL-UHFFFAOYSA-N eriodictyol 7-O-rutinoside Natural products OC1C(O)C(O)C(C)OC1OCC1C(O)C(O)C(O)C(OC=2C=C3C(C(C(O)=C(O3)C=3C=C(O)C(O)=CC=3)=O)=C(O)C=2)O1 IVTMALDHFAHOGL-UHFFFAOYSA-N 0.000 description 7
- FDRQPMVGJOQVTL-UHFFFAOYSA-N quercetin rutinoside Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC=2C(C3=C(O)C=C(O)C=C3OC=2C=2C=C(O)C(O)=CC=2)=O)O1 FDRQPMVGJOQVTL-UHFFFAOYSA-N 0.000 description 7
- IKGXIBQEEMLURG-BKUODXTLSA-N rutin Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@@H]1OC[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](OC=2C(C3=C(O)C=C(O)C=C3OC=2C=2C=C(O)C(O)=CC=2)=O)O1 IKGXIBQEEMLURG-BKUODXTLSA-N 0.000 description 7
- ALABRVAAKCSLSC-UHFFFAOYSA-N rutin Natural products CC1OC(OCC2OC(O)C(O)C(O)C2O)C(O)C(O)C1OC3=C(Oc4cc(O)cc(O)c4C3=O)c5ccc(O)c(O)c5 ALABRVAAKCSLSC-UHFFFAOYSA-N 0.000 description 7
- 235000005493 rutin Nutrition 0.000 description 7
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- 208000031226 Hyperlipidaemia Diseases 0.000 description 2
- RXUWDKBZZLIASQ-UHFFFAOYSA-N Puerarin Natural products OCC1OC(Oc2c(O)cc(O)c3C(=O)C(=COc23)c4ccc(O)cc4)C(O)C(O)C1O RXUWDKBZZLIASQ-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 239000012141 concentrate Substances 0.000 description 2
- 238000007405 data analysis Methods 0.000 description 2
- HKEAFJYKMMKDOR-VPRICQMDSA-N puerarin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1C1=C(O)C=CC(C2=O)=C1OC=C2C1=CC=C(O)C=C1 HKEAFJYKMMKDOR-VPRICQMDSA-N 0.000 description 2
- 239000013558 reference substance Substances 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- DCXXMTOCNZCJGO-UHFFFAOYSA-N tristearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCC DCXXMTOCNZCJGO-UHFFFAOYSA-N 0.000 description 2
- 229920000858 Cyclodextrin Polymers 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 240000007594 Oryza sativa Species 0.000 description 1
- 235000007164 Oryza sativa Nutrition 0.000 description 1
- 235000008331 Pinus X rigitaeda Nutrition 0.000 description 1
- 235000011613 Pinus brutia Nutrition 0.000 description 1
- 241000018646 Pinus brutia Species 0.000 description 1
- 244000046101 Sophora japonica Species 0.000 description 1
- 235000010586 Sophora japonica Nutrition 0.000 description 1
- 235000010599 Verbascum thapsus Nutrition 0.000 description 1
- 229960000583 acetic acid Drugs 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
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- 229940125898 compound 5 Drugs 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
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- 238000004134 energy conservation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 201000005577 familial hyperlipidemia Diseases 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000012362 glacial acetic acid Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 235000019353 potassium silicate Nutrition 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 235000009566 rice Nutrition 0.000 description 1
- 229940087332 rutin 10 mg Drugs 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000011003 system suitability test Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 238000003809 water extraction Methods 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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- A61K36/232—Angelica
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/482—Cassia, e.g. golden shower tree
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/50—Methods involving additional extraction steps
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- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
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- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
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- Engineering & Computer Science (AREA)
- Mycology (AREA)
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Abstract
The present invention relates to a kind of preparation method of heart maitong capsule, comprise the following steps：1. pseudo-ginseng is crushed；Pseudo-ginseng is crushed, granularity is obtained for 80 targeted fine powders；2. the sophora bud extracts inclusion；Obtain Huai Goat inclusion compound；3. the extraction of Radix Angelicae Sinensis, yncaria stem with hooks；Plus 8 times of amount decoctings boil secondary, 40 minutes every time, it is concentrated into appropriate.Plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant to filter, filtrate recycling ethanol is concentrated into 1.25 1.30.4. the red sage root, Pachyrhizua angulatus, cassia seed, ilex pubescens, selfheal, the extraction of root of bidentate achyranthes Six-element medicine；Add water to cook secondary, 30 60 minutes every time, added water 8 12 times of amounts for the first time, the 2nd 8 12 times of amounts that add water.5. above-mentioned gained pseudo-ginseng medicinal powder, Huai Goat inclusion compound, Radix Angelicae Sinensis, the extract of yncaria stem with hooks and the red sage root, Pachyrhizua angulatus, cassia seed, ilex pubescens, selfheal, the extract of root of bidentate achyranthes Six-element medicine and auxiliary material mixing, encapsulated to produce.
Description
Technical field
The present invention relates to a kind of preparation method of heart maitong capsule.Belong to pharmaceutical technology field.
Technical background
Heart maitong capsule belongs to prior art, by Radix Angelicae Sinensis, cassia seed, yncaria stem with hooks, the root of bidentate achyranthes, the red sage root, Pachyrhizua angulatus, the sophora bud, ilex pubescens,
Totally 10 kinds of Chinese medicines are processed that capsule is made for selfheal, pseudo-ginseng.With promoting blood circulation and removing blood stasis, freeing vessels and nourishing heart, effect of hypertension and hyperlipemia is used
In hypertension, hyperlipidemia etc..Clinical efficacy significantly, is widely used.
Existing heart maitong capsule is at (consumption the is parts by weight) heart maitong capsule being prepared from by following traditional Chinese medicine raw medicine
Side is as follows：
【Preparation method】In the taste medicinal material of the above ten, in addition to pseudo-ginseng is ground into fine powder, after the sophora bud is added in boiling water, adjusted with milk of lime
PH to 8.5, decocts secondary, filtration, and merging filtrate adjusts PH to 4.0~5.0 with hydrochloric acid, stands 24 hours, and leaching precipitation is done
It is dry, it is ground into fine powder, Radix Angelicae Sinensis, yncaria stem with hooks add water to cook secondary, filtration, merging filtrate, is concentrated into appropriate, plus ethanol makes the alcohol content be
70%, 24 hours are stood, takes supernatant to filter, filtrate recycling ethanol is concentrated into thick paste.The Six-elements such as remaining red sage root add water to cook two
Secondary, filtration, merging filtrate is concentrated into thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Chinese scholartree
Rice extracts fine powder is mixed, and particle is made, and dries, 1000 capsules are made, produce.
Because existing heart maitong capsule has significant curative effect, but the content degraded that this product is present to treatment hypertension, hyperlipidemia,
The problems such as drawing moist stronger, this product is there is greater risk in quality, be unfavorable for the sales promotion of product.
The present invention provides a kind of heart maitong capsule new process formula, and the technological parameter in original formulation is optimized, and makes this
The stability of kind is greatly improved.
The content of the invention
It is an object of the invention to provide a kind of preparation method of heart maitong capsule.The present invention also aims to provide one
Plant the bag and technology of Huai Goat.The present invention also aims to provide a kind of anti-hygroscopic technology of capsule.
The preparation method of the heart maitong capsule of the present invention, it is characterised in that comprise the following steps：
1. pseudo-ginseng is crushed；Pseudo-ginseng is crushed, granularity is obtained for 80 targeted fine powders；
2. the sophora bud extracts inclusion；Obtain Huai Goat inclusion compound；
3. the extraction of Radix Angelicae Sinensis, yncaria stem with hooks；Plus 8 times of amount decoctings boil secondary, 40 minutes every time, it is concentrated into appropriate.Plus ethanol makes to contain
Alcohol amount is 70%, stands 24 hours, takes supernatant to filter, filtrate recycling ethanol is concentrated into 1.25-1.30.
4. the red sage root, Pachyrhizua angulatus, cassia seed, ilex pubescens, selfheal, the extraction of root of bidentate achyranthes Six-element medicine；Add water to cook it is secondary, every time
30-60 minutes, add water 8-12 times and measure for the first time, add water 8-12 times for the 2nd time and to measure.
5. above-mentioned gained pseudo-ginseng medicinal powder, Huai Goat inclusion compound, Radix Angelicae Sinensis, the extract of yncaria stem with hooks and the red sage root, Pachyrhizua angulatus, certainly
Pine torch, ilex pubescens, selfheal, the extract of root of bidentate achyranthes Six-element medicine and auxiliary material mixing, it is encapsulated to produce.
The sophora bud of the present invention is extracted, and is extracted using hot technique of backflow, measures water extraction 2 times with 8 times, every time 30 minutes, PH
Control 8.5, merges extract solution concentrate drying and produces.
Huai Goat of the present invention, needs further exist for progress cyclodextrin encapsulated.Method is as follows：Take beta-schardinger dextrin 100
Part adds appropriate water, adds 10 parts of Huai Goat ethanol solution, and stirring and dissolving is ground certain time using colloid mill, cooling
To -1~15 DEG C, filtering obtains 30~40 DEG C of dryings of solids, obtains Huai Goat inclusion compound.
Therefore, heart maitong capsule of the invention, wherein the exactly Huai Goat inclusion compound used.
Heart maitong capsule prepared by the method for the present invention, with excellent technique effect, its technical scheme is by screening
Obtain, screening process is as follows：
Step 2. the sophora bud extraction carry out process optimization, using hot technique of backflow.4 are pressed by inspection target of the rutin rate of transform
The level of factor 3 carries out orthogonal experiment, and experimental result and variance analysis are shown in Table 1, table 2, table 3.
The water-glass of 4 factor 3 that the influence sophora bud of table 1 is extracted
The orthogonal design table that table 2 is screened on extraction factor
The variance analysis of the factor of the rate of transform is extracted in the influence of table 3
Visible through analyzing, extraction time, quantity of solvent have a significant impact to prescription, and extraction process can be drawn according to average
Parameter combination is using extraction time as 30 minutes, and Extraction solvent is water, and quantity of solvent is that 8 times of amounts are optimal collocation, by this scheme to
Fang Jinhang process optimizations.As a result of hot technique of backflow, the content rate of transform of medicinal material is greatly improved, technique road is shortened
Line, it is to avoid the potential problems that the hydrochloric acid introduced in former technique is brought to product quality.Therefore optimised process is：Using heat backflow
Technology is extracted, and is extracted 2 times with 8 times of amount water, 30 minutes every time, PH controls 8.5.
Traditional decocting process easily makes medicinal material local temperature too high, it is impossible to complete desorption, dissolving, diffusion very well.Using
Hot technique of backflow, Extraction solvent can constantly be desorbed with medicinal material, dissolve, spread, and then reach the effect fully extracted.Should
Technology is that solvent is continuously fed on powder, from top to bottom by medicinal material layer, solutes content in the solutes content and solvent in medicinal material
Maintain the solute high speed dissolution in higher gradient, medicinal material, until complete dissolution, with extraction efficiency it is high the characteristics of.Extract solution
Stop being pumped into inspissator, the indirect steam of concentration transfers cooler, and concentration proceeds, until being condensed into medicinal extract, release standby,
Due to solute high speed dissolution, extraction time is short, and concentration is carried out simultaneously with extracting, and concentration takes economic benefits and social benefits to concentrate, and the technology can be quick
Concentrated extracting solution, effectively saves the energy.Therefore medicinal material is shorter than traditional time to concentration ointment, utilization rate of equipment and installations is high.The technology
Operate as medicinal material is put into extractor, dosing material certain amount water, open extractor and lead directly to and jacket steam valve, make medicinal material
Extract after certain time, extract solution is pumped into inspissator and concentrated.The surface that the solvent of heat falls on medicinal material is extracted, and completes one
Individual continuous extraction and concentration.
In order to improve the stability of Huai Goat in heart maitong capsule, following preferred process has been carried out：
Take 100 parts of beta-schardinger dextrin to add appropriate water, add 10 parts of Huai Goat ethanol solution, stirring and dissolving is used
Colloid mill grinds certain time, is cooled to -1~15 DEG C, filtering obtains 30~40 DEG C of dryings of solids, obtains Huai Goat bag
Compound.It is shown in Table 4
Huai Goat inclusion compound prepares table in the heart maitong capsule of table 4
It is most reasonable with inclusion compound 5 according to the balance of material and rational application.
Investigate the stability of inclusion compound and non-inclusion compound
The assay method of rutin content in Huai Goat：
【Assay】Determined according to high performance liquid chromatography (D of annex VI).
Chromatographic condition is filler with octadecylsilane chemically bonded silica with system suitability test；With acetonitrile-methanol-
Water-glacial acetic acid (50：100：350：13) it is mobile phase, 40 DEG C of column temperature；Detection wavelength 254nm.Theoretical cam curve is calculated by rutin,
3000 should be not less than.
The preparation precision of reference substance solution weighs control substance of Rutin 10mg, puts in 50ml measuring bottles, molten with a small amount of methanol ultrasound
Solution, with methanol dilution to scale, shakes up, then draws 2ml and be diluted to 10ml, produces (1ml μ g containing rutin 40).
The preparation of need testing solution takes the content under this product content uniformity, mixes, takes 0.1g, accurately weighed, puts tool
Fill in conical flask, precision adds methanol 50ml, and weighed weight ultrasonically treated 30 minutes, is let cool, then weighed weight, is mended with methanol
The weight of sufficient less loss, filtration, takes subsequent filtrate, with (0.45 μm) filtration of miillpore filter, produces.
Determination method is accurate respectively to draw reference substance solution and each 10 μ l of need testing solution, injects liquid chromatograph, determines, i.e.,
.
Scheme 1：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
PH is to 8.5, then decocts secondary, and 30 minutes every time, filtration, merging filtrate adjusted PH to 4.0~5.0 with hydrochloric acid, stands 24 small
When, leaching precipitation dry, pulverize into fine powder, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil secondary, 40 minutes every time,
Filtration, merging filtrate is concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant to filter, filtrate is returned
Ethanol is received, relative density 1.25-1.30 thick paste is concentrated into.The Six-elements such as remaining red sage root (totally 700 grams) add water to cook secondary, filter
Cross, merging filtrate is concentrated into thick paste.Above-mentioned thick paste is carried with Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, the sophora bud
Take thing fine powder to mix, particle is made, dry, 1000 capsules are made.
Scheme 2：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoction is secondary, and filtration, merging filtrate is concentrated into thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% tristearin
Sour magnesium, Huai Goat inclusion compound fine powder are mixed, and particle is made, and dry, 1000 capsules are made.
Accelerated stability is investigated and the results are shown in Table 5
The content accelerated stability of 6 months of Huai Goat rutin is investigated in the heart maitong capsule of table 5
As a result show：The stability of inclusion compound is better than directly with the effect of Huai Goat.Add Huai Goat
The stability of middle rutin content.
Step 4. the Six-element medicine such as red sage root extraction carry out process optimization, using the content of Puerarin as Testing index, be shown in Table 6.
The Six-element medicine such as red sage root of table 6 extraction process is investigated
Decoction 2 times is drawn by data analysis, 60 minutes every time, the mean transferred rate of the content of its Puerarin was far above other
Group.On the multiple of amount of water, 10 times and 8 times of groups and 12 times and 10 times of groups are almost consistent in the content rate of transform, are dropped from energy-conservation
The angle analysis of consumption, as optimal：The multiple that adds water is 10 times and 8 times, minute/time of decocting time 60.Receive cream proportion 1.25-
1.30。
Because heart maitong capsule is wet granulation, paste containing amount is larger, and particle draws moist stronger.For this case, open
Exhibition is anti-to draw moist technology, from step 5., step 8. carry out, to draw moist data for reference index progress process optimization.It is shown in Table 7.
Table 7 draws moist technique investigation table
| Method of granulating | Particle moisture content (%) | Draw moist (%) |
| Standard technology preparation method | 4.5 | 11 |
| Standard technology preparation method | 3 | 11 |
| Standard technology preparation method | 1.5 | 12 |
| Moistureproof coating-Eudragit L100 | 4.5 | 4 |
| Moistureproof coating-Eudragit L100 | 3 | 3 |
| Moistureproof coating-Eudragit L100 | 1.5 | 4 |
| Moistureproof coating-Kollicaot IR | 4.5 | 3 |
| Moistureproof coating-Kollicaot IR | 3 | 4 |
| Moistureproof coating-Kollicaot IR | 1.5 | 3 |
| Spray-drying pelleting machine (Inner adds anti-blushing agent) | 4.5 | 2 |
| Spray-drying pelleting machine (Inner adds anti-blushing agent) | 3 | 1 |
| Spray-drying pelleting machine (Inner adds anti-blushing agent) | 1.5 | 1 |
It can be seen that by upper table data：Moistureproof coating-Eudragit L100 and Kollicaot IR and spray-drying process
Machine can effectively reduce that drawing for particle is moist, and the moisture content with particle drying is without larger association.From a cost perspective, use
Eudragit L100 are more reasonable.But it draws moist still ＞ 2% to the particle through moistureproof coating, therefore need to 8. increase by one in step
Moisture-proof cover, to ensure that the moisture content of capsule before the deadline is qualified.As optimal, step 5. in charging in clear cream and auxiliary material it is total
Mass percent concentration control 16%, and by anti-blushing agent press grain amount 2%, be configured to 3% ethanol solution, with clear cream
EAT is mixed with the mixture of auxiliary material to control in air temperature to be 175 DEG C, feed rate is controlled in 22ml/mim.
Scheme 1：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
PH is to 8.5, then decocts secondary, and 30 minutes every time, filtration, merging filtrate adjusted PH to 4.0~5.0 with hydrochloric acid, stands 24 small
When, leaching precipitation dry, pulverize into fine powder, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil secondary, 40 minutes every time,
Filtration, merging filtrate is concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant to filter, filtrate is returned
Ethanol is received, relative density 1.25-1.30 thick paste is concentrated into.The Six-elements such as remaining red sage root (totally 700 grams) add water to cook secondary, filter
Cross, merging filtrate is concentrated into thick paste.Above-mentioned thick paste is carried with Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, the sophora bud
Take thing fine powder to mix, particle is made, dry, 1000 capsules are made.
Scheme 2：：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoct secondary, 60 minutes every time, add water 10 times and measure for the first time, add water 8 times for the 2nd time and to measure, filter, merging filtrate, be concentrated into relative
Density 1.25-1.30 thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Huai Goat
Inclusion compound fine powder, Eudragit L100 solution, are mixed, and are pelletized, and dry, 1000 capsules are made.
Scheme 3：：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoct secondary, 60 minutes every time, add water 10 times and measure for the first time, add water 8 times for the 2nd time and to measure, filter, merging filtrate, be concentrated into relative
Density 1.25-1.30 thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Huai Goat
Inclusion compound fine powder, Eudragit L100 solution, are mixed, and are pelletized, and dry, 1000 capsules are made.Increase a protection against the tide during packaging
Bag.
Scheme 4：：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoct secondary, 60 minutes every time, add water 10 times and measure for the first time, add water 8 times for the 2nd time and to measure, filter, merging filtrate, be concentrated into relative
Density 1.25-1.30 thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Huai Goat
Inclusion compound fine powder, 3%Eudragit L100 ethanol solutions, are pelletized drying, clear cream and auxiliary material in charging using spray dryer
Total mass percent concentration is controlled 16%, and anti-blushing agent is pressed into the 2% of grain amount, is configured to 3% ethanol solution, and clear
The mixture of cream and auxiliary material mixes EAT and controls in air temperature to be 175 DEG C, and feed rate is controlled in 22ml/mim, is made
1000 capsules.Accelerated stability is investigated and the results are shown in Table 8
The accelerated stability data of 8 above-mentioned 4 schemes of table
Drawn from above-mentioned all data analyses：The advantage of the invention is that：Products obtained therefrom oxidation resistance is strong, stability
By force, curative effect is stable；Integrated artistic is easily operated, suitable for popularization and application.
The present invention is continued to optimize by the technique to prescription, improves the rate of transform of rutin in the sophora bud, and uses inclusion technique
The stability of Huai Goat is improved, while drawing the stability that moist technology improves capsule using anti-.Curative effect is not reduced simultaneously,
The stability of heart maitong capsule is greatly improved.
Embodiment
The present invention is described in further detail with reference to embodiments.
Embodiment 1：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
PH is saved to 8.5, then decocts secondary, 30 minutes every time, filtration, merging filtrate adjusted PH to 4.0~5.0 with hydrochloric acid, stands 24 small
When, leaching precipitation dry, pulverize into fine powder, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil secondary, 40 minutes every time,
Filtration, merging filtrate is concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant to filter, filtrate is returned
Ethanol is received, relative density 1.25-1.30 thick paste is concentrated into.The Six-elements such as remaining red sage root (totally 700 grams) add water to cook secondary, filter
Cross, merging filtrate is concentrated into thick paste.Above-mentioned thick paste is carried with Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, the sophora bud
Take thing fine powder to mix, particle is made, dry, 1000 capsules are made.Packaging, is produced.
Embodiment 2：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoction is secondary, and filtration, merging filtrate is concentrated into relative density 1.25-1.30 thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch,
Microcrystalline cellulose, 1% magnesium stearate, Huai Goat inclusion compound fine powder are mixed, and particle is made, and dry, 1000 capsules are made.
Packaging, is produced.
Embodiment 3：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoct secondary, 60 minutes every time, add water 10 times and measure for the first time, add water 8 times for the 2nd time and to measure, filter, merging filtrate is concentrated into thick paste.
Above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Huai Goat inclusion compound fine powder are mixed, are made
Particle, dries, 1000 capsules is made.
Embodiment 4：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoct secondary, 60 minutes every time, add water 10 times and measure for the first time, add water 8 times for the 2nd time and to measure, filter, merging filtrate, be concentrated into relative
Density 1.25-1.30 thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Huai Goat
Inclusion compound fine powder, 3%Eudragit L100 ethanol solutions, are mixed, and are pelletized, and dry, 1000 capsules are made.Packaging, is produced.
Embodiment 5：6 grams of pseudo-ginseng is ground into 80 targeted fine powders, after 100 grams of the sophora bud is added in 8 times of amount boiling water, is adjusted with milk of lime
Save PH to 8.5, using circumfluence distillation technology, then decoct it is secondary, 30 minutes every time, receive cream, fine powder is dry, pulverize into, by 7 parts
The ratio of Huai Goat and 100 parts of beta-schardinger dextrins prepares inclusion compound, and 185 grams of Radix Angelicae Sinensis, 125 grams plus 8 times amount decoctings of yncaria stem with hooks boil two
Secondary, 40 minutes every time, filtration, merging filtrate was concentrated into right amount, plus ethanol makes alcohol content be 70%, stands 24 hours, takes supernatant
Liquid is filtered, and filtrate recycling ethanol is concentrated into relative density 1.25-1.30 thick paste.The Six-elements such as remaining red sage root (totally 700 grams) add water
Decoct secondary, 60 minutes every time, add water 10 times and measure for the first time, add water 8 times for the 2nd time and to measure, filter, merging filtrate, be concentrated into relative
Density 1.25-1.30 thick paste.By above-mentioned thick paste and Radix Notoginseng powder, starch, microcrystalline cellulose, 1% magnesium stearate, Huai Goat
Inclusion compound fine powder, 3%Eudragit L100 ethanol solutions, are pelletized drying, clear cream and auxiliary material in charging using spray dryer
Total mass percent concentration is controlled 16%, and anti-blushing agent is pressed into the 2% of grain amount, is configured to 3% ethanol solution, and clear
The mixture of cream and auxiliary material mixes EAT and controls in air temperature to be 175 DEG C, and feed rate is controlled in 22ml/mim, is made
1000 capsules.Packaging, is produced.
Claims (1)
1. a kind of preparation method of heart maitong capsule, it is characterised in that comprise the following steps：
Radix Angelicae Sinensis 185g cassia seed 185g yncaria stem with hooks 125g roots of bidentate achyranthes 125g
Red sage root 100g Pachyrhizua angulatus 100g sophora bud 100g ilex pubescens 100g
Selfheal 100g pseudo-ginseng 6g
1. pseudo-ginseng is crushed；Pseudo-ginseng is crushed, granularity is obtained for 80 targeted fine powders；
2. the sophora bud extracts inclusion；Obtain Huai Goat inclusion compound；
3. the extraction of Radix Angelicae Sinensis, yncaria stem with hooks；Plus 8 times of amount decoctings boil secondary, 40 minutes every time, are concentrated into right amount, plus ethanol makes alcohol content
For 70%, 24 hours are stood, takes supernatant to filter, filtrate recycling ethanol is concentrated into 1.25-1.30,
4. the red sage root, Pachyrhizua angulatus, cassia seed, ilex pubescens, selfheal, the extraction of root of bidentate achyranthes Six-element medicine；Add water to cook it is secondary, 60 points every time
Clock, adds water 10 times and measures for the first time, adds water 8 times for the 2nd time and to measure；
5. above-mentioned gained pseudo-ginseng medicinal powder, Huai Goat inclusion compound, Radix Angelicae Sinensis, the extract of yncaria stem with hooks and the red sage root, Pachyrhizua angulatus, cassia seed,
Ilex pubescens, selfheal, the extract of root of bidentate achyranthes Six-element medicine and auxiliary material mixing, it is encapsulated to produce；
Wherein, the sophora bud extracts inclusion, and step is as follows：Water refluxing extraction is measured with 8 times 2 times, 30 minutes every time, pH controls 8.5,
Merge extract solution to be concentrated and dried, take 100 parts of addition water of beta-schardinger dextrin, add 10 parts of the ethanol solution of Huai Goat, stir molten
Solution, is ground using colloid mill, is cooled to -1~15 DEG C, filtering obtains solids, 30~40 DEG C of dryings obtain Huai Goat
Inclusion compound.
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| Title |
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| 芦丁-β-环糊精包合物的研究;邵伟等;《中药材》;19980131;第21卷(第01期);31-33 * |
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