CN107028911B - A kind of Chinese medicine composition self-emulsifying soft capsule and preparation method thereof for treating hemorrhoid - Google Patents
A kind of Chinese medicine composition self-emulsifying soft capsule and preparation method thereof for treating hemorrhoid Download PDFInfo
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 26
- 208000014617 hemorrhoid Diseases 0.000 title claims abstract description 25
- 239000003814 drug Substances 0.000 title claims abstract description 22
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000000203 mixture Substances 0.000 title claims abstract description 11
- 239000000341 volatile oil Substances 0.000 claims abstract description 32
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 24
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 claims abstract description 24
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 24
- 229940116229 borneol Drugs 0.000 claims abstract description 24
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 claims abstract description 24
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 claims abstract description 24
- 239000000284 extract Substances 0.000 claims abstract description 24
- 239000012141 concentrate Substances 0.000 claims abstract description 11
- 241001313855 Bletilla Species 0.000 claims abstract description 9
- 235000004256 Buglossoides arvense Nutrition 0.000 claims abstract description 9
- 241001547125 Fritillaria thunbergii Species 0.000 claims abstract description 9
- 241000118841 Lithospermum incisum Species 0.000 claims abstract description 9
- 240000004980 Rheum officinale Species 0.000 claims abstract description 9
- 235000008081 Rheum officinale Nutrition 0.000 claims abstract description 9
- 238000000605 extraction Methods 0.000 claims description 26
- 239000000463 material Substances 0.000 claims description 19
- 235000019441 ethanol Nutrition 0.000 claims description 17
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 14
- 239000003921 oil Substances 0.000 claims description 13
- 239000002775 capsule Substances 0.000 claims description 11
- 238000002156 mixing Methods 0.000 claims description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 10
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 9
- 229920000053 polysorbate 80 Polymers 0.000 claims description 9
- 238000004945 emulsification Methods 0.000 claims description 7
- 239000000839 emulsion Substances 0.000 claims description 7
- 235000011187 glycerol Nutrition 0.000 claims description 7
- 239000007788 liquid Substances 0.000 claims description 6
- 108010010803 Gelatin Proteins 0.000 claims description 5
- 229920000159 gelatin Polymers 0.000 claims description 5
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- 235000019322 gelatine Nutrition 0.000 claims description 5
- 235000011852 gelatine desserts Nutrition 0.000 claims description 5
- 230000010355 oscillation Effects 0.000 claims description 5
- 238000010992 reflux Methods 0.000 claims description 5
- 238000001256 steam distillation Methods 0.000 claims description 5
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims description 5
- 210000002459 blastocyst Anatomy 0.000 claims description 4
- 238000002347 injection Methods 0.000 claims description 4
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- 238000000926 separation method Methods 0.000 claims description 2
- 238000005259 measurement Methods 0.000 claims 1
- 239000003995 emulsifying agent Substances 0.000 abstract description 14
- 239000004519 grease Substances 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 5
- 239000004530 micro-emulsion Substances 0.000 abstract description 3
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 description 17
- 235000019198 oils Nutrition 0.000 description 11
- 229940079593 drug Drugs 0.000 description 10
- 210000003491 skin Anatomy 0.000 description 8
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- 201000010099 disease Diseases 0.000 description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
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- LVGKNOAMLMIIKO-UHFFFAOYSA-N Elaidinsaeure-aethylester Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC LVGKNOAMLMIIKO-UHFFFAOYSA-N 0.000 description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 3
- 210000002255 anal canal Anatomy 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 239000003937 drug carrier Substances 0.000 description 3
- LVGKNOAMLMIIKO-QXMHVHEDSA-N ethyl oleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC LVGKNOAMLMIIKO-QXMHVHEDSA-N 0.000 description 3
- 229940093471 ethyl oleate Drugs 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000010298 pulverizing process Methods 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 2
- 206010030113 Oedema Diseases 0.000 description 2
- 241000283973 Oryctolagus cuniculus Species 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 229920001214 Polysorbate 60 Polymers 0.000 description 2
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 210000000436 anus Anatomy 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
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- 238000004090 dissolution Methods 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 239000002085 irritant Substances 0.000 description 2
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- 230000035699 permeability Effects 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 2
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- 210000005070 sphincter Anatomy 0.000 description 2
- 230000002269 spontaneous effect Effects 0.000 description 2
- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 description 1
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- WWUVLNPEWUTCEI-KRWDZBQOSA-N Flowerone Chemical compound C1=C(O)C(CC=C(C)C)=CC([C@H]2OC3=C(O)C(O)=CC(O)=C3C(=O)C2)=C1 WWUVLNPEWUTCEI-KRWDZBQOSA-N 0.000 description 1
- XEUCQOBUZPQUMQ-UHFFFAOYSA-N Glycolone Chemical compound COC1=C(CC=C(C)C)C(=O)NC2=C1C=CC=C2OC XEUCQOBUZPQUMQ-UHFFFAOYSA-N 0.000 description 1
- UWIULCYKVGIOPW-UHFFFAOYSA-N Glycolone Natural products CCOC1=C(CC=CC)C(=O)N(C)c2c(O)cccc12 UWIULCYKVGIOPW-UHFFFAOYSA-N 0.000 description 1
- 239000008118 PEG 6000 Substances 0.000 description 1
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 1
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 210000003363 arteriovenous anastomosis Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000002615 epidermis Anatomy 0.000 description 1
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- 238000002474 experimental method Methods 0.000 description 1
- YVBUWVMMORNHHZ-UHFFFAOYSA-N flowerone Natural products CC(=C)CCc1cc(ccc1O)C1CC(=O)c2c(O)cc(O)c(O)c2O1 YVBUWVMMORNHHZ-UHFFFAOYSA-N 0.000 description 1
- 208000035861 hematochezia Diseases 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000004006 olive oil Substances 0.000 description 1
- 235000008390 olive oil Nutrition 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 238000003359 percent control normalization Methods 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 229940057847 polyethylene glycol 600 Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229960004063 propylene glycol Drugs 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 229940083466 soybean lecithin Drugs 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- PHYFQTYBJUILEZ-IUPFWZBJSA-N triolein Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CCCCCCCC)COC(=O)CCCCCCC\C=C/CCCCCCCC PHYFQTYBJUILEZ-IUPFWZBJSA-N 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K36/13—Coniferophyta (gymnosperms)
- A61K36/14—Cupressaceae (Cypress family), e.g. juniper or cypress
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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)
- A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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)
- A61K36/57—Magnoliaceae (Magnolia family)
- A61K36/575—Magnolia
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- A—HUMAN NECESSITIES
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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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/708—Rheum (rhubarb)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8966—Fritillaria, e.g. checker lily or mission bells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- 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 or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
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Abstract
The invention discloses a kind of Chinese medicine composition self-emulsifying soft capsules and preparation method thereof for treating hemorrhoid, and Chinese medicinal composition and weight proportion are：11.7 parts of rheum officinale, 11.7 parts of fritillaria thunbergii, 33.3 parts of Asian puccoon, 33.3 parts of Cortex Magnoliae Officinalis, 33.3 parts of cacumen biotae, 16.7 parts of bletilla, 1 part of borneol, extract its volatile oil and Alcohol soluble composition, it is equipped with grease, emulsifier, assistant for emulsifying agent, self-emulsifying microemulsion concentrate is made, soft capsule is made in conventional manner.The self-emulsifying soft capsule preparation method of the present invention is simple, can improve assimilation effect, safety curative for effect, and stability is good, quality controllable.
Description
Technical field
The invention belongs to the field of Chinese medicines, it is related to a kind of Chinese medicine composition self-emulsifying soft capsule that treating hemorrhoid and its preparation side
Method.
Background technology
Hemorrhoid are common disease, frequently-occurring disease.Internal piles is the support structure, plexus vasculosus and arteriovenous anastomosis Zhi Fasheng of anal canal blood vessel pad
Pathology sexually revise and abnormal displacement；External piles is the pathologic expansion that inferior rectal veins belongs to branch veniplex under the epidermis of dentate line distal side
And thrombosis；Mixed hemorrhoid is that internal piles is mutually melted by the outer hemorrhoidal plexus of abundant veniplex ramus anastomoticus and corresponding site
It closes.The main clinical manifestation of dysporia is dry and hard excrement, and defecation is time-consuming and laborious, is just felt not to the utmost, defecation obstruction sense, and stool is tired
Difficulty, pathogenic factor are complicated.Modern age, doctor thought, the cause of disease of constipation not instead of hemorrhoid, the secondary symptom of hemorrhoid.Hemorrhoid and constipation cause and effect
The change of relationship on concept promotes people that corresponding change has occurred in treatment idea.The property constipation of hemorrhoid source is since hemorrhoid cause
High anus pressure, high internal sphincter pressure, high external sphincter pressure, anal canal compliance and sensibility are low, anal canal high pressure belt extend etc. change and
Cause, non-operative treatment has critical role in the property constipation therapy of hemorrhoid source.
The Suppository for treatment of pile involved in technical solution in early stage of the invention, is Jiuhua Zhichuang Shuan, may include that following weight is matched
The Chinese medicine material and pharmaceutic adjuvant of ratio：11.7 parts of rheum officinale, 11.7 parts of fritillaria thunbergii, 33.3 parts of Asian puccoon, 33.3 parts of Cortex Magnoliae Officinalis, cacumen biotae
33.3 parts, 16.7 parts of bletilla, 1 part of borneol；PEG400053.3 parts and PEG600085.7 parts.
But rabbit experiment shows that rheum officinale, fritillaria thunbergii, Asian puccoon, Cortex Magnoliae Officinalis, cacumen biotae, bletilla, borneol are being made as medicinal ingredient
While at suppository in treatment hemorrhoid, the PEG4000 and PEG6000 of selection are irritant to rectal mucosa, refer in December, 2007
Institute of Guiyang University reports the 4th phase summary of volume 2《The progress of suppository》The 5.2.2 of page 47 saves the 7 to 11st row " usually not by two kinds
With the polyethylene glycol melting mixing of molecular weight, the matrix of desired consistency and characteristic can be obtained.This class matrix is not required to refrigerate, storage side
Just.But hygroscopicity is strong, makes moist yielding, irritant to rectal mucosa ... ... ".This stimulation consequence shows as rabbit anus
Red and swollen or oedema, or both have both at the same time.
To avoid above-mentioned deficiency, spy from proposing the present invention.Self-emulsifying microemulsion drug medicine-releasing system is by drug, grease, emulsifier
The homogeneous and transparent solution formed with assistant for emulsifying agent, in the case of environment temperature (being often referred to 37 DEG C or so) and gentle agitation,
Due to the presence of emulsifier, spontaneous emulsification at 5 microns emulsion.It is spontaneous in body with increasing for emulsifier
Micro emulsion is formed, drug is present in these tiny oil droplets, is quickly distributed, is carried significantly by the huge specific surface area of fine oil droplets
The high dissolution of water-insoluble drug, increases the permeability of drug epithelial cell, promotes the absorption of drug, substantially increase drug
Bioavilability.
Invention content
The present invention provides a kind of Chinese medicine composition self-emulsifying soft capsule and preparation method thereof for treating hemorrhoid, technique letters
It is single, dosage is small, active ingredient and bioavilability are high, improve the utilization rate of volatile oil and the self-emulsifying soft capsule of stability and its
Preparation method.
Technical solution：
The primary and foremost purpose of the present invention is to provide a kind of self-emulsifying soft capsule for treating hemorrhoid：
It is a further object to provide a kind of preparation methods of the self-emulsifying soft capsule.
The present invention is achieved through the following technical solutions：
A kind of Chinese medicine composition self-emulsifying soft capsule for treating hemorrhoid, content include volatile oil, drug extract and
Pharmaceutical carrier, by weight percentage, the volatile oil and drug extract are about the 20% of pharmaceutical carrier；
The pharmaceutical carrier by weight percentage, is made of grease 25%, emulsifier 60% and assistant for emulsifying agent 15%；
The weight proportion of the Chinese medicine is：11.7 parts of rheum officinale, 11.7 parts of fritillaria thunbergii, 33.3 parts of Asian puccoon, 33.3 parts of Cortex Magnoliae Officinalis,
33.3 parts of cacumen biotae, 16.7 parts of bletilla, 1 part of borneol.
Preferably：The grease is selected from medium chain triglyceride (MCT), ethyl oleate, olein, soybean oil, flower
One or more of oil generation, olive oil.
Preferably：The emulsifier is selected from polysorbas20, Tween 80, tween 35, phosphatide, liquid lecithin, soybean lecithin
And one or more of cholesterol；
Preferably：The assistant for emulsifying agent is in ethyl alcohol, isopropanol, 1,2- propylene glycol, n-butanol, glycerine, polyethylene glycol
One or more.
The specific preparation method of self-emulsifying soft capsule of the present invention includes the following steps：
A, by component composition and ratio weigh 11.7 parts of rheum officinale, 11.7 parts of fritillaria thunbergii, 33.3 parts of Asian puccoon, 33.3 parts of Cortex Magnoliae Officinalis,
33.3 parts of cacumen biotae, 16.7 parts of bletilla, 1 part of borneol, it is spare；
B, the extraction of above-mentioned medicinal material volatile oil
(1)CO2Supercritical extract：By the above-mentioned pulverizing medicinal materials in addition to borneol at the particle of 20-60 mesh, CO2Overcritical extraction
It takes, in extracting pressure 20-35MPa, 45-65 DEG C of extraction temperature, CO2It extracts 0.5-3 hours, detaches under the conditions of flow velocity 20-40L/h
Collect volatile oil；
(2) it extracts the dregs of a decoction after volatile oil to be extracted 2 times with 70% alcohol reflux, it is medicinal material weight that amount of alcohol is added every time
4-6 times, each extraction time is 1-2.5 hours, and extraction gained liquid merges, and being concentrated into relative density after recycling ethyl alcohol is
The medicinal extract of 1.25-1.30 (60 DEG C), it is spare；
Or it is medicinal material weight that (3), which use the volatile oil of the above-mentioned medicinal material in addition to borneol of extraction by steam distillation, amount of water,
2-4 times of amount, extraction time are 4-8 hours；
C, grease mixing is added in volatile oil, medicinal extract and the borneol extracted step b, obtains oil phase；
D, emulsifier, assistant for emulsifying agent, ground and mixed is added, is stirred with the rotating speed of 30-40rpm in 25-35 DEG C of water bath with thermostatic control
It mixes 1-2 hours, is allowed to be completely dissolved, obtains Emulsion Phase；
E, oil phase is mixed with emulsification, at 25-35 DEG C, with stirring, oscillation, ultrasound or swirling manner mixing, is formed
Self-emulsifying concentrate；
F, gelatin, glycerine, water are weighed and prepares capsule skin, or sorbierite plasticising is added, or polyoxyethylene sorbitan monoleate defoaming is added；
G, by above-mentioned self-emulsifying concentrate and capsule skin, soft capsule is made in conventional manner.
Preferably, the specific preparation method of self-emulsifying soft capsule of the present invention includes the following steps：
A, by component composition and ratio weigh 11.7 parts of rheum officinale, 11.7 parts of fritillaria thunbergii, 33.3 parts of Asian puccoon, 33.3 parts of Cortex Magnoliae Officinalis,
33.3 parts of cacumen biotae, 16.7 parts of bletilla, 1 part of borneol, it is spare；
B, the extraction of above-mentioned medicinal material volatile oil
(1)CO2Supercritical extract：By the above-mentioned pulverizing medicinal materials in addition to borneol at the particle of 20 mesh, CO2Supercritical extract,
Extracting pressure 25MPa, 60 DEG C of extraction temperature, CO2It is extracted 1.5 hours under the conditions of flow velocity 30L/h, separates and collects volatile oil；
(2) it extracts the dregs of a decoction after volatile oil to be extracted 2 times with 70% alcohol reflux, it is medicinal material weight that amount of alcohol is added every time
5 times, each extraction time is 1.5 hours, and extraction gained liquid merges, and it is 1.25- that relative density is concentrated into after recycling ethyl alcohol
The medicinal extract of 1.30 (60 DEG C), it is spare；
Or it is medicinal material weight that (3), which use the volatile oil of the above-mentioned medicinal material in addition to borneol of extraction by steam distillation, amount of water,
3 times of amount, extraction time are 6 hours；
C, grease mixing is added in volatile oil, medicinal extract and the borneol extracted step b, obtains oil phase；
D, emulsifier, assistant for emulsifying agent, ground and mixed is added, it is small with the stirring 1.5 of the rotating speed of 35rpm in 30 DEG C of waters bath with thermostatic control
When, it is allowed to be completely dissolved, obtains Emulsion Phase；
E, oil phase is mixed, the sonic oscillation at 30 DEG C, mixing with emulsification, forms self-emulsifying concentrate；
F, by weight 1:0.25-0.6:1, which weighs gelatin, glycerine, water, prepares capsule skin, or is added and glycerine equivalent weight
Sorbierite plasticising, or the polyoxyethylene sorbitan monoleate defoaming of blastocysts injection total amount 0.2% is added；
G, by above-mentioned self-emulsifying concentrate and capsule skin, soft capsule is made in conventional manner.
The self-emulsifying soft capsule of the present invention compared with prior art, has the following advantages that：
The preparation of the present invention can effectively improve bioavilability：Drug of the present invention by it is oral enter gastrointestinal tract after, can be with
Contact with moisture therein, which is formed, carries the small emulsion droplet of medicine, increases medical surfaces product and solubility, be able to gastrointestinal tract uniformly, rapidly
Distribution is easy to be transmitted to absorption site by hydrated sheath, improves dissolution rate and permeability, bioavilability greatly improve, effectively
Solve the problems, such as that volatile oil is difficult to absorb in human body low with bioavailability in prescription, curative for effect, safety.
Specific implementation mode
Below by specific embodiment, the present invention is further described, it is noted that for the ordinary skill of this field
For personnel, without departing from the principle of the present invention, several variations and modifications can also be made, these also should be regarded as belonging to
Protection scope of the present invention.
Embodiment 1
1, extraction by steam distillation volatile oil
Rheum officinale 117g, fritillaria thunbergii 117g, Asian puccoon 333g, Cortex Magnoliae Officinalis 333g, cacumen biotae 333g, bletilla 167g, borneol 10g
Using the volatile oil of the above-mentioned medicinal material in addition to borneol of extraction by steam distillation, amount of water is 3 times of medicinal material weight, is carried
It is 6 hours to take the time, after extraction separation volatile oil 6g, it is spare.
The dregs of a decoction after said extracted volatile oil are extracted 2 times with 70% alcohol reflux, and it is medicinal material weight that amount of alcohol is added every time
5 times, each extraction time be 1.5 hours, extraction gained liquid merge, recycle ethyl alcohol after be concentrated into relative density be 1.25-
1.30 (60 DEG C) obtain medicinal extract 100g, spare；
2, prepared by self-emulsifying soft capsule
Content prescription：Volatile oil 6g, medicinal extract 100g, borneol 10g, medium chain triglyceride 175g, Tween 80 350g, poly- second
Glycol 40055g is made 2000
Preparation process：
1, volatile oil, medicinal extract, borneol are taken, medium chain triglyceride mixing is added, obtains oil phase；
2, Tween 80, polyethylene glycol 400 ground and mixed is added, 1.5 are stirred with the rotating speed of 35rpm in 30 DEG C of waters bath with thermostatic control
Hour, it is allowed to be completely dissolved, obtains Emulsion Phase；
3, oil phase and emulsification are mixed, the sonic oscillation at 30 DEG C, mixing, forms self-emulsifying concentrate；
4, by weight 1:0.5:1, which weighs gelatin, glycerine, water, prepares capsule skin, and glue blastocysts injection total amount 0.2% is added
Polysorbate 80 defoams；
5, by step 3 gained self-emulsifying concentrate and step 4 gained capsule skin, soft capsule is made in conventional manner.
Embodiment 2
1、CO2Supercritical extract volatile oil
Rheum officinale 117g, fritillaria thunbergii 117g, Asian puccoon 333g, Cortex Magnoliae Officinalis 333g, cacumen biotae 333g, bletilla 167g, borneol 10g
By the above-mentioned pulverizing medicinal materials in addition to borneol at the particle of 20 mesh, CO2Supercritical extract, in extracting pressure 25MPa, extraction
Take temperature 60 C, CO2It is extracted 1.5 hours under the conditions of flow velocity 30L/h, separates and collects volatile oil, obtain volatile oil 7g, it is spare.
The dregs of a decoction after said extracted volatile oil are extracted 2 times with 70% alcohol reflux, and it is medicinal material weight that amount of alcohol is added every time
5 times, each extraction time be 1.5 hours, extraction gained liquid merge, recycle ethyl alcohol after be concentrated into relative density be 1.25-
The medicinal extract 99g of 1.30 (60 DEG C), it is spare；
2, prepared by self-emulsifying soft capsule
Content prescription：Volatile oil 7g, medicinal extract 99g, borneol 10g, ethyl oleate 145g, Tween 80 345g, polyethylene glycol
600 90g are made 2000
Preparation process：
1, volatile oil, medicinal extract, borneol are taken, ethyl oleate mixing is added, obtains oil phase；
2, Tween 80, Macrogol 600 ground and mixed is added, it is small with the stirring 2 of the rotating speed of 40rpm in 35 DEG C of waters bath with thermostatic control
When, it is allowed to be completely dissolved, obtains Emulsion Phase；
3, oil phase and emulsification are mixed, the sonic oscillation at 30 DEG C, mixing, forms self-emulsifying concentrate；
4, by weight 1:0.5:1, which weighs gelatin, glycerine, water, prepares capsule skin, and glue blastocysts injection total amount 0.2% is added
Polysorbate 80 defoams；
5, by step 3 gained self-emulsifying concentrate and step 4 gained capsule skin, soft capsule is made in conventional manner.
In order to observe clinical efficacy of the self-emulsification capsule of the present invention to hemorrhoid, we select patent CN102120001A to prepare
Suppository for treatment of pile medicine (comparative example 1) as a contrast, treatment observation is carried out to 66 hemorrhoid patients,
Brief summary is as follows.
1 clinical data
1.1 observation objects
This group 66 be each phase internal piles, all kinds of inflammatory external hemorrhoids, mixed hemorrhoid patient, age 18-65 Sui.Randomly select it
In 33 be self-emulsifying soft capsule treatment group of the present invention, 33 be control group.Male 20 in treatment group, women 13 are average
It is 43.3 years old age, 62 years old maximum, it is 18 years old minimum；Control group male 19, women 14, average age 42.7 years old is 65 years old maximum,
It is 22 years old minimum.
2 groups of patients are compared with age, gender and the course of disease etc., no significant difference (P>0.05) it, is comparable.
1.2 diagnostic criteria：Oedema pain, has blood in stool, deviates from.
1.3 administrated method
Treatment group：Self-emulsifying soft capsule (preparation of embodiment 1) of the present invention, 2 tablets each time, 3 times a day.
Control group：Particle prepared by comparative example 1,1 tablet each time, 2 times a day.
The course for the treatment of is 3 days.
2 results
2.1 curative effects compare
| Group | Recovery from illness | It is effective | Effectively | In vain | Total effective rate |
| Treatment group (n=33) | 18 (54.54%) | 9 (27.27%) | 5 (15.15%) | 1 (3.03%) | 96.97% |
| Control group (n=33) | 13 (39.39%) | 8 (24.24%) | 7 (21.21%) | 5 (15.15%) | 84.84% |
As can be seen from the above table, self-emulsifying soft capsule of the invention is significant in efficacy, is better than suppository.
Claims (1)
1. a kind of preparation method of Chinese medicine composition self-emulsifying soft capsule that treating hemorrhoid, which is characterized in that include the following steps：
Rheum officinale 117g, fritillaria thunbergii 117g, Asian puccoon 333g, Cortex Magnoliae Officinalis 333g, cacumen biotae 333g, bletilla 167g, borneol 10g,
Using the volatile oil of the above-mentioned medicinal material in addition to borneol of extraction by steam distillation, amount of water is 3 times of medicinal material weight, when extraction
Between be 6 hours, after extraction separation volatile oil 6g, it is spare,
The dregs of a decoction after said extracted volatile oil are extracted 2 times with 70% alcohol reflux, and 5 that amount of alcohol is medicinal material weight are added every time
Times, each extraction time is 1.5 hours, and extraction gained liquid merges, 60 DEG C of measurement, and being concentrated into relative density after recycling ethyl alcohol is
1.25-1.30 medicinal extract 100g is obtained, it is spare；
It is prepared by self-emulsifying soft capsule
Content prescription：Volatile oil 6g, medicinal extract 100g, borneol 10g, medium chain triglyceride 175g, Tween 80 350g, poly- second two
400 55g of alcohol, is made 2000
Preparation process：
1) volatile oil, medicinal extract, borneol, are taken, medium chain triglyceride mixing is added, obtains oil phase；
2) Tween 80, polyethylene glycol 400 ground and mixed, is added, it is small with the stirring 1.5 of the rotating speed of 35rpm in 30 DEG C of waters bath with thermostatic control
When, it is allowed to be completely dissolved, obtains Emulsion Phase；
3), oil phase and emulsification are mixed, the sonic oscillation at 30 DEG C, mixing, forms self-emulsifying concentrate；
4), by weight 1:0.5:1, which weighs gelatin, glycerine, water, prepares capsule skin, and the poly- of glue blastocysts injection total amount 0.2% is added
Sorbierite 80 defoams；
5), by step 3 gained self-emulsifying concentrate and step 4 gained capsule skin, soft capsule is made in conventional manner.
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| CN201710337956.4A CN107028911B (en) | 2017-05-15 | 2017-05-15 | A kind of Chinese medicine composition self-emulsifying soft capsule and preparation method thereof for treating hemorrhoid |
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| CN105055528B (en) * | 2015-08-10 | 2019-02-15 | 山东罗欣药业集团股份有限公司 | A kind of Chinese medicine composition self-emulsifying soft capsule and preparation method thereof for treating flu |
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