CN1322858C - Geranol drip pill and its preparation method - Google Patents
Geranol drip pill and its preparation method Download PDFInfo
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- CN1322858C CN1322858C CNB2005100693044A CN200510069304A CN1322858C CN 1322858 C CN1322858 C CN 1322858C CN B2005100693044 A CNB2005100693044 A CN B2005100693044A CN 200510069304 A CN200510069304 A CN 200510069304A CN 1322858 C CN1322858 C CN 1322858C
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- geraniol
- polyethylene glycol
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- 239000006187 pill Substances 0.000 title claims abstract description 44
- 238000002360 preparation method Methods 0.000 title abstract description 28
- GLZPCOQZEFWAFX-UHFFFAOYSA-N Geraniol Chemical compound CC(C)=CCCC(C)=CCO GLZPCOQZEFWAFX-UHFFFAOYSA-N 0.000 claims abstract description 176
- 239000005792 Geraniol Substances 0.000 claims abstract description 88
- GLZPCOQZEFWAFX-YFHOEESVSA-N Geraniol Natural products CC(C)=CCC\C(C)=C/CO GLZPCOQZEFWAFX-YFHOEESVSA-N 0.000 claims abstract description 88
- 229940113087 geraniol Drugs 0.000 claims abstract description 88
- 239000003814 drug Substances 0.000 claims abstract description 31
- 239000000203 mixture Substances 0.000 claims abstract description 12
- 239000002994 raw material Substances 0.000 claims abstract description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims description 82
- 239000002202 Polyethylene glycol Substances 0.000 claims description 81
- 239000000758 substrate Substances 0.000 claims description 43
- -1 polyoxyethylene stearate Polymers 0.000 claims description 36
- 150000002148 esters Chemical class 0.000 claims description 28
- 229920002472 Starch Polymers 0.000 claims description 25
- 235000019698 starch Nutrition 0.000 claims description 25
- 239000008107 starch Substances 0.000 claims description 25
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 22
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 22
- 239000011734 sodium Substances 0.000 claims description 22
- 229910052708 sodium Inorganic materials 0.000 claims description 22
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 6
- 239000000839 emulsion Substances 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 2
- 229940057995 liquid paraffin Drugs 0.000 claims description 2
- 238000000465 moulding Methods 0.000 claims description 2
- 229920002545 silicone oil Polymers 0.000 claims description 2
- 238000003756 stirring Methods 0.000 claims description 2
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 2
- 239000008158 vegetable oil Substances 0.000 claims description 2
- 238000005303 weighing Methods 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 abstract description 59
- 206010062717 Increased upper airway secretion Diseases 0.000 abstract description 12
- 208000026435 phlegm Diseases 0.000 abstract description 12
- 206010011224 Cough Diseases 0.000 abstract description 11
- 238000004519 manufacturing process Methods 0.000 abstract description 10
- 206010006458 Bronchitis chronic Diseases 0.000 abstract description 6
- 206010006451 bronchitis Diseases 0.000 abstract description 6
- 208000007451 chronic bronchitis Diseases 0.000 abstract description 6
- 210000004072 lung Anatomy 0.000 abstract description 6
- 230000008901 benefit Effects 0.000 abstract description 4
- 201000010099 disease Diseases 0.000 abstract description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 3
- 210000000936 intestine Anatomy 0.000 abstract description 3
- 210000002784 stomach Anatomy 0.000 abstract description 3
- 239000000126 substance Substances 0.000 abstract description 3
- 208000000059 Dyspnea Diseases 0.000 abstract 1
- 206010013975 Dyspnoeas Diseases 0.000 abstract 1
- 238000009825 accumulation Methods 0.000 abstract 1
- 230000007547 defect Effects 0.000 abstract 1
- 229940023488 pill Drugs 0.000 description 35
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 27
- 229920001983 poloxamer Polymers 0.000 description 27
- 229960000502 poloxamer Drugs 0.000 description 27
- 238000002474 experimental method Methods 0.000 description 21
- 229920000858 Cyclodextrin Polymers 0.000 description 20
- 239000001116 FEMA 4028 Substances 0.000 description 20
- 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 description 20
- 235000011175 beta-cyclodextrine Nutrition 0.000 description 20
- 229960004853 betadex Drugs 0.000 description 20
- 238000000034 method Methods 0.000 description 19
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 16
- 229940079593 drug Drugs 0.000 description 16
- 238000012360 testing method Methods 0.000 description 16
- 239000008194 pharmaceutical composition Substances 0.000 description 13
- 239000004615 ingredient Substances 0.000 description 12
- 239000000969 carrier Substances 0.000 description 9
- 239000001828 Gelatine Substances 0.000 description 8
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 8
- 239000004141 Sodium laurylsulphate Substances 0.000 description 8
- 235000021355 Stearic acid Nutrition 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- 229920000159 gelatin Polymers 0.000 description 8
- 235000019322 gelatine Nutrition 0.000 description 8
- 235000011187 glycerol Nutrition 0.000 description 8
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 8
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 8
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 8
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 8
- 239000008117 stearic acid Substances 0.000 description 8
- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 description 7
- 238000002156 mixing Methods 0.000 description 7
- 239000007901 soft capsule Substances 0.000 description 7
- 230000000694 effects Effects 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- 238000011282 treatment Methods 0.000 description 6
- 206010036790 Productive cough Diseases 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 5
- 239000011248 coating agent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 239000000428 dust Substances 0.000 description 4
- 230000036541 health Effects 0.000 description 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 238000009833 condensation Methods 0.000 description 2
- 230000005494 condensation Effects 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 239000008157 edible vegetable oil Substances 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 238000010579 first pass effect Methods 0.000 description 2
- 230000002496 gastric effect Effects 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 235000015250 liver sausages Nutrition 0.000 description 2
- 239000007935 oral tablet Substances 0.000 description 2
- 229940096978 oral tablet Drugs 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000000600 sorbitol Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 1
- MYMOFIZGZYHOMD-UHFFFAOYSA-N Dioxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 102000000340 Glucosyltransferases Human genes 0.000 description 1
- 108010055629 Glucosyltransferases Proteins 0.000 description 1
- 241001640034 Heteropterys Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004353 Polyethylene glycol 8000 Substances 0.000 description 1
- 229920002701 Polyoxyl 40 Stearate Polymers 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 208000013116 chronic cough Diseases 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 235000001727 glucose Nutrition 0.000 description 1
- 125000002791 glucosyl group Chemical class C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 210000003750 lower gastrointestinal tract Anatomy 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 230000029052 metamorphosis Effects 0.000 description 1
- 239000004531 microgranule Substances 0.000 description 1
- 210000002200 mouth mucosa Anatomy 0.000 description 1
- 229920001542 oligosaccharide Polymers 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- FDRCDNZGSXJAFP-UHFFFAOYSA-M sodium chloroacetate Chemical compound [Na+].[O-]C(=O)CCl FDRCDNZGSXJAFP-UHFFFAOYSA-M 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medicinal composition having the advantages of relieving coughs and eliminating phlegm and used for treating the accumulation of phlegm-dampness in the lung, such as chronic bronchitis, coughs, copious phlegm and dyspnea. The present invention aims to overcome the defects of the oral medicinal preparation for treating the diseases and provide an oral preparation, namely a geraniol drop pill, which has the advantages of high bioavailability, no residual substance in the intestine and stomach after administration, quick medicine release, high effectual speed, high medicine content, convenient administration, low price and no pollution during production. The geraniol drop pill of the present invention is prepared by using the Chinese medicine geraniol as the raw material and a medicinal vector used as a matrix.
Description
Technical field
The present invention relates to a kind of cough-relieving that has, phlegm-dispelling functions is used for chronic bronchitis, cough, and abundant expectoration is breathed heavily and is suppressed the pharmaceutical composition that belongs to treatments such as phlegm dampness obstructing the lung symptom, is the drug composition oral preparation that feedstock production forms with the Chinese medicine geraniol particularly.
Background technology
The geraniol soft capsule that is prepared from according to the preparation method that provides among the national drug standards WS-10886 (ZD-0886)-2002, it is a kind of cough-relieving that has, phlegm-dispelling functions, be used for chronic bronchitis, cough, abundant expectoration, breathe heavily and suppress the oral tablet that belongs to treatments such as phlegm dampness obstructing the lung symptom, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be the brief description among the drug standard WS-10886 (ZD-0886)-2002:
Nomenclature of drug: geraniol soft capsule
Prescription: geraniol 20g, refined edible oil 180g
Method for making: get geraniol, add refined edible oil, mixing, the soft capsule of packing into, promptly.
Function cures mainly: cough-relieving, eliminate the phlegm.Be used for chronic bronchitis, cough, abundant expectoration is breathed heavily and is suppressed genus phlegm dampness obstructing the lung symptom person.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.Though soft capsule also has the high advantage of bioavailability, is subjected to the influence of its coating material, the storage time reaches half a year when above, promptly is prone to catabiosis, and making that coating material enters behind the intestines and stomach can not fine dissolving and produce residue.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention is to replenish the existing chronic bronchitis that is used for, cough, abundant expectoration, breathe heavily the deficiency of suppressing the oral drug preparation that belongs to treatments such as phlegm dampness obstructing the lung symptom, a kind of bioavailability height is provided, take hindgut gastric noresidue material, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations Geranol drip pill.Geranol drip pill involved in the present invention is a raw material with the Chinese medicine geraniol, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain Geranol drip pill involved in the present invention:
[preparation method]
1. raw material: geraniol
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, geraniol: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, base is placed heating while stirring in the heating container, standby until the fused solution that obtains containing geraniol and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of geraniol and substrate and/or emulsion and/or suspension places in the dropping-pill machine head jar, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[beneficial effect]
The geraniol soft capsule that is prepared from according to the preparation method that provides among the national drug standards WS-10886 (ZD-0886)-2002, it is a kind of cough-relieving that has, phlegm-dispelling functions, be used for chronic bronchitis, cough, abundant expectoration, breathe heavily and suppress the oral tablet that belongs to treatments such as phlegm dampness obstructing the lung symptom, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.Though soft capsule also has the high advantage of bioavailability, is subjected to the influence of its coating material, the storage time reaches half a year when above, promptly is prone to catabiosis, and making that coating material enters behind the intestines and stomach can not fine dissolving and produce residue.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Geranol drip pill involved in the present invention, compare with the geraniol soft capsule and to have following beneficial effect:
1. Geranol drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with geraniol, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. Geranol drip pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. Geranol drip pill involved in the present invention mixes the geraniol that contains active pharmaceutical ingredient mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of Geranol drip pill of the present invention.
[first group: the test of single-matrix]
1. raw material: geraniol
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can get the Geranol drip pill of different size.
[result of the test]
Test 1: for observe geraniol and different substrates when 1: 1 the proportioning prepared Geranol drip pill in qualitative difference, according to 1: 1 ratio, with geraniol respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment of 13 geraniol and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe geraniol and different substrates when 1: 3 the proportioning prepared Geranol drip pill in qualitative difference, according to 1: 3 ratio, with geraniol respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment of 13 geraniol and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe geraniol and different substrates when 1: 9 the proportioning prepared Geranol drip pill in qualitative difference, according to 1: 9 ratio, with geraniol respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain the pharmaceutical composition experiment of 13 geraniol and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: geraniol
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and geraniol: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can get the Geranol drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of geraniol are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 4.
Test 5: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of geraniol are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 5.
Test 6: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of geraniol are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 6.
Test 7: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of geraniol are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 7.
Test 8: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of geraniol are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 8.
Test 9: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of geraniol are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio geraniol is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio geraniol is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of geraniol and mixed-matrix prepared Geranol drip pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio geraniol is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that geraniol and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 12.
The group practices of table 1 geraniol and single-matrix
(geraniol: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 73 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 85 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 85 | ＜30 | ＞10 | + |
| Polyethylene Glycol 10000 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 70 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 50.0 | 79 | ＞30 | ＞10 | ++ |
| Stearic acid | 50.0 | 73 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 69 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 67 | ＞30 | ＞10 | + |
| Lac | 50.0 | 66 | ＞30 | ＞10 | + |
The group practices of table 2 geraniol and single-matrix
(geraniol: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 82 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 25.0 | 90 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 76 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 89 | ＜30 | ＜10 | ++ |
| Poloxamer | 25.0 | 90 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 78 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 74 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 73 | ＞30 | ＞10 | +++ |
The group practices of table 3 geraniol and single-matrix
(geraniol: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 85 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 10.0 | 91 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 78 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 82 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 77 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 76 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 75 | ＞30 | ＞10 | +++ |
The group practices of table 4 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 83 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 81 | ＜30 | ＞10 | + |
The group practices of table 5 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 6 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 85 | ＜30 | ＞10 | +++ |
The group practices of table 7 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 90 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 87 | ＜30 | ＜10 | ++ |
The group practices of table 8 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜1 0 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜1 0 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 90 | ＜30 | ＜1 0 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜1 0 | +++ |
The group practices of table 9 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 88 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 89 | ＜30 | ＜10 | +++ |
The group practices of table 10 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 88 | ＜30 | ＞10 | +++ |
The group practices of table 11 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 12 geraniol and mixed-matrix
(geraniol: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 89 | ＜30 | ＜10 | +++ |
1. can be seen by the result in the table: when the ratio of geraniol and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of geraniol and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of geraniol and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. a Geranol drip pill is a raw material with the Chinese medicine geraniol, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, and the ratio of geraniol and substrate is 1: 3;
(2) according to aforementioned proportion, accurately take by weighing geraniol and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing geraniol and substrate and/or emulsion and/or suspension;
(3) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃:
When (4) treating that dropping-pill machine head and condensing agent reach described state of temperature respectively, will contain fused solution and/or the emulsion and/or the suspension of geraniol and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. Geranol drip pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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Non-Patent Citations (5)
| Title |
|---|
| 中药药剂学 范碧亭，380-383，上海科学技术出版社 1997 * |
| 固体分散体在缓控释制剂中的应用 胡道德等，中国医药工业杂志，第33卷第5期 2002 * |
| 国家中成药标准汇编（肺系）2册 国家药品监督管理局，519，国家药品监督管理局 2002 * |
| 葛根素固体分散体的制备及其在体外研究 周毅生等，中国药学杂志，第38卷第1期 2003 * |
| 葛根素固体分散体的制备及其在体外研究 周毅生等，中国药学杂志，第38卷第1期 2003;固体分散体在缓控释制剂中的应用 胡道德等，中国医药工业杂志，第33卷第5期 2002;国家中成药标准汇编（肺系）2册 国家药品监督管理局，519，国家药品监督管理局 2002;中药药剂学 范碧亭，380-383，上海科学技术出版社 1997 * |
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