CN1686339A - Compound cynomorium drip pill and its preparation method - Google Patents
Compound cynomorium drip pill and its preparation method Download PDFInfo
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- CN1686339A CN1686339A CN 200510055385 CN200510055385A CN1686339A CN 1686339 A CN1686339 A CN 1686339A CN 200510055385 CN200510055385 CN 200510055385 CN 200510055385 A CN200510055385 A CN 200510055385A CN 1686339 A CN1686339 A CN 1686339A
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- Prior art keywords
- polyethylene glycol
- extract
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- mixed
- schisandrae chinensis
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- 239000006187 pill Substances 0.000 title claims abstract description 47
- 150000001875 compounds Chemical class 0.000 title claims description 33
- 238000002360 preparation method Methods 0.000 title claims description 31
- 241000500125 Cynomorium coccineum Species 0.000 title abstract 2
- 239000003814 drug Substances 0.000 claims abstract description 95
- 206010010774 Constipation Diseases 0.000 claims abstract description 7
- 239000000284 extract Substances 0.000 claims description 91
- 229920001223 polyethylene glycol Polymers 0.000 claims description 91
- 239000002202 Polyethylene glycol Substances 0.000 claims description 89
- 229940079593 drug Drugs 0.000 claims description 80
- 239000000758 substrate Substances 0.000 claims description 47
- -1 sorbitol anhydride Chemical class 0.000 claims description 41
- 229920002472 Starch Polymers 0.000 claims description 34
- 235000019698 starch Nutrition 0.000 claims description 34
- 239000008107 starch Substances 0.000 claims description 34
- 241000500128 Cynomorium Species 0.000 claims description 32
- 229920000858 Cyclodextrin Polymers 0.000 claims description 31
- 239000001116 FEMA 4028 Substances 0.000 claims description 31
- 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 31
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 31
- 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 31
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims description 31
- 229960004853 betadex Drugs 0.000 claims description 31
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 31
- 229920001983 poloxamer Polymers 0.000 claims description 31
- 229960000502 poloxamer Drugs 0.000 claims description 31
- 239000011734 sodium Substances 0.000 claims description 31
- 229910052708 sodium Inorganic materials 0.000 claims description 31
- 150000002148 esters Chemical class 0.000 claims description 30
- 238000000034 method Methods 0.000 claims description 23
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 20
- 239000000796 flavoring agent Substances 0.000 claims description 16
- 235000019634 flavors Nutrition 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 15
- 239000008194 pharmaceutical composition Substances 0.000 claims description 14
- 239000001828 Gelatine Substances 0.000 claims description 10
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 10
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 10
- 235000021355 Stearic acid Nutrition 0.000 claims description 10
- 239000004480 active ingredient Substances 0.000 claims description 10
- 229920000159 gelatin Polymers 0.000 claims description 10
- 235000019322 gelatine Nutrition 0.000 claims description 10
- 235000011187 glycerol Nutrition 0.000 claims description 10
- 235000008216 herbs Nutrition 0.000 claims description 10
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 10
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 10
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 10
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 10
- 239000008117 stearic acid Substances 0.000 claims description 10
- 239000009636 Huang Qi Substances 0.000 claims description 9
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 201000010099 disease Diseases 0.000 claims description 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 7
- 239000002994 raw material Substances 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 206010021118 Hypotonia Diseases 0.000 claims description 6
- 208000017561 flaccidity Diseases 0.000 claims description 6
- 238000010438 heat treatment Methods 0.000 claims description 6
- 210000000936 intestine Anatomy 0.000 claims description 6
- 210000000629 knee joint Anatomy 0.000 claims description 6
- 239000000706 filtrate Substances 0.000 claims description 5
- 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 claims description 4
- 239000008186 active pharmaceutical agent Substances 0.000 claims description 4
- 239000000839 emulsion Substances 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 239000000600 sorbitol Substances 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 3
- 238000009833 condensation Methods 0.000 claims description 3
- 230000005494 condensation Effects 0.000 claims description 3
- 238000004821 distillation Methods 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 239000012567 medical material Substances 0.000 claims description 3
- 235000015424 sodium Nutrition 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
- 239000008280 blood Substances 0.000 abstract description 5
- 210000003734 kidney Anatomy 0.000 abstract description 5
- 210000004185 liver Anatomy 0.000 abstract description 5
- 235000013399 edible fruits Nutrition 0.000 abstract 2
- 244000241838 Lycium barbarum Species 0.000 abstract 1
- 235000015459 Lycium barbarum Nutrition 0.000 abstract 1
- 235000015468 Lycium chinense Nutrition 0.000 abstract 1
- 240000006079 Schisandra chinensis Species 0.000 abstract 1
- 235000008422 Schisandra chinensis Nutrition 0.000 abstract 1
- 210000004369 blood Anatomy 0.000 abstract 1
- 210000003127 knee Anatomy 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 description 58
- 238000002474 experimental method Methods 0.000 description 21
- 238000012360 testing method Methods 0.000 description 16
- 239000004615 ingredient Substances 0.000 description 12
- 238000009472 formulation Methods 0.000 description 10
- 239000000969 carrier Substances 0.000 description 9
- 230000000694 effects Effects 0.000 description 9
- 239000007788 liquid Substances 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- 238000002156 mixing Methods 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 7
- 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
- 238000005516 engineering process Methods 0.000 description 7
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 7
- 229920000053 polysorbate 80 Polymers 0.000 description 7
- 210000000988 bone and bone Anatomy 0.000 description 4
- 239000000428 dust Substances 0.000 description 4
- 210000003205 muscle Anatomy 0.000 description 4
- 238000005728 strengthening Methods 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000002775 capsule Substances 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
- 238000010579 first pass effect Methods 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
- 235000015250 liver sausages Nutrition 0.000 description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 2
- 235000010234 sodium benzoate Nutrition 0.000 description 2
- 239000004299 sodium benzoate Substances 0.000 description 2
- 239000000126 substance Substances 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
- 229920002701 Polyoxyl 40 Stearate Polymers 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 239000000470 constituent 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
- 230000007613 environmental effect Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000002496 gastric effect Effects 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
- 229960003511 macrogol Drugs 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 238000005259 measurement Methods 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
- 239000000047 product Substances 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
- 238000004064 recycling Methods 0.000 description 1
- 210000003296 saliva Anatomy 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
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
A Chinese medicine in the form of dripping pill for nourishing liver, kidney and blood, and treating sore lumbus and knee, constipation etc is prepared from cynomorium, wolfberry fruit and schisandra fruit.
Description
Technical field
The present invention relates to a kind of have invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening effect, it is soft to be used for waist knee joint flaccidity, the pharmaceutical composition of treatment for diseases such as dryness of the intestine constipation is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis particularly.
Background technology
The compound cynomorium oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-10709 (ZD-0709)-2002, be a kind of have invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening effect, it is soft to be used for waist knee joint flaccidity, the oral granular formulation of treatment for diseases such as dryness of the intestine constipation, 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 prescription and technology and the brief description that provides in WS-10709 (ZD-0709)-2002 drug standard:
Prescription: Herba Cynomorii 240, Fructus Lycii 120, Fructus Schisandrae Chinensis 120, Mel 120, sodium benzoate 0.3
Method for making: above three flavor medical materials, get the Fructus Schisandrae Chinensis vapor distillation, collect distillate 500ml, standby; Other gets Herba Cynomorii, Fructus Lycii and the merging of Fructus Schisandrae Chinensis medicinal residues, soaks 12 hours, decocts secondary, 1.5 hours for the first time, 1 hour for the second time, gradation filtered, merging filtrate also is concentrated into the clear paste that relative density is 1.10 (50 ℃), adds ethanol and makes and contain alcohol amount and reach 60%～65%, leaves standstill 24 hours, filter, filtrate recycling ethanol adds 2 times of water gagings to there not being the ethanol flavor, mixing, left standstill 24 hours, and filtered, get medicinal liquid.Other gets Mel, adds water boil 30 minutes, filters, and filtrate and above-mentioned medicinal liquid mixing add sodium benzoate, add water to ormal weight, packing, and sterilization, promptly.
Function cures mainly: invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening.It is soft to be used for waist knee joint flaccidity, the dryness of the intestine constipation.
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.It is low that oral liquid also has a medicament contg, and dose is not accurate enough and take inconvenient shortcoming.
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, be to replenish that existing to be used for waist knee joint flaccidity soft, the deficiency of the oral drug preparation of treatment for diseases such as dryness of the intestine constipation, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, accurate measurement, taking convenience, cheap, and free of contamination aborning oral formulations compound cynomorium drip pill.Compound cynomorium drip pill involved in the present invention is a raw material with the extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain compound cynomorium drip pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis;
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, by weight, and Radix Astragali extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing Radix Astragali extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Radix Astragali extract 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 drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, 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.
[appendix: a kind of 3 flavor active ingredient of Chinese herbs preparation method of extract such as Herba Cynomorii that contain] is unit with g or kg, according to the weight portion meter, takes by weighing 2 parts of Herba Cynomoriis, 1 part of Fructus Lycii, 1 part of Fructus Schisandrae Chinensis; More than 3 the flavor medical materials, get the Fructus Schisandrae Chinensis vapor distillation, the collection distillate standby; Other gets Herba Cynomorii, Fructus Lycii and Fructus Schisandrae Chinensis medicinal residues and merges, soaked 12 hours, and decocted the 1st time 1.5 hours 2 times, the 2nd time 1 hour, gradation filters, and merging filtrate also adds preceding distillate, is decompressed to 0.1Mpa, under 60 ℃ condition, be condensed into relative density and be 1.3～1.35 thick paste, or continue to make drying, be ground into dry powder, promptly.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
[beneficial effect]
The compound cynomorium oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-10709 (ZD-0709)-2002, be a kind of have invigorating the liver and kidney, benefiting essence-blood, bone and muscle strengthening effect, it is soft to be used for waist knee joint flaccidity, the oral granular formulation of treatment for diseases such as dryness of the intestine constipation, 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.It is low that oral liquid also has a medicament contg, and dose is not accurate enough and take inconvenient shortcoming.
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.
Compound cynomorium drip pill involved in the present invention is compared with the compound cynomorium oral liquid has following beneficial effect:
1. compound cynomorium drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. compound cynomorium 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. compound cynomorium drip pill involved in the present invention mixes the extract that contains active constituents of medicine 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 compound cynomorium drip pill of the present invention.
First group: the test of single-matrix
1. raw material: it is standby to make the extract dry powder that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis earlier according to [appendix];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and Radix Astragali extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the compound cynomorium drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared compound cynomorium drip pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared compound cynomorium drip pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared compound cynomorium drip pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: it is standby to make the extract dry powder that contains 3 flavor Chinese medicine active pharmaceutical ingredients such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis earlier according to [appendix];
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 Radix Astragali extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the compound cynomorium drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and mixed-matrix prepared compound cynomorium 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 drug extract 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 drug extract 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 drug extract and single-matrix
(drug extract: 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 | ??67 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??86 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??50.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 10000 | ??50.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??87 | ??＜30 | ??＜10 | ??++ |
| Span 40 | ??50.0 | ??61 | ??＜30 | ??＞10 | ??++ |
| Tween 80 | ??50.0 | ??60 | ??＜30 | ??＞10 | ??+ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??88 | ??＜30 | ??＜10 | ??+ |
| Betacyclodextrin | ??50.0 | ??79 | ??＜30 | ??＞10 | ??+ |
| Poloxamer | ??50.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Carboxymethyl starch sodium | ??50.0 | ??76 | ??＜30 | ??＞10 | ??+ |
| Sodium lauryl sulphate | ??50.0 | ??73 | ??＞30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??60 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??61 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??61 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??62 | ??＞30 | ??＞10 | ??+ |
The group practices of table 2 drug extract and single-matrix
(drug extract: 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 | ??67 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??68 | ??＜30 | ??＞10 | ??+++ |
| Tween 80 | ??25.0 | ??67 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??91 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??25.0 | ??86 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??25.0 | ??86 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??78 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??25.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??25.0 | ??73 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: 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 | ??84 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 4000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??78 | ??＜30 | ??＞10 | ??+++ |
| Tween 80 | ??10.0 | ??79 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??92 | ??＜30 | ??＜10 | ??++ |
| Betacyclodextrin | ??10.0 | ??86 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium | ??10.0 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??79 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??77 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??73 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??74 | ??＞30 | ??＞10 | ??+++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: 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 | ??85 | ??＜30 | ??＞10 | ??++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??50 | ??84 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??82 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??76 | ??＜30 | ??＞10 | ??+ |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: 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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??25 | ??84 | ??＜30 | ??＞10 | ??++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: 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 | ??92 | ??＜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 | ??83 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: 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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??50 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??50 | ??87 | ??＜30 | ??＜10 | ??++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: 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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??25 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: 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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??10 | ??89 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: 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 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??50 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??89 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: 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 | ??92 | ??＜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 | ??87 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: 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 | ??93 | ??＜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 drug extract 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 drug extract 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 drug extract 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 (6)
- One kind to be used for waist knee joint flaccidity soft, the pharmaceutical composition compound cynomorium drip pill of treatment for diseases such as dryness of the intestine constipation, with the extract that contains Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis etc. 3 flavor active ingredient of Chinese herbs is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:1.1 raw material: the extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis;1.2 substrate: 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, above-mentioned carrier one or more mixture wherein;1.3 proportioning: with g or kg is unit, by weight, and Radix Astragali extract: substrate=1: 1～1: 9.
- 2. compound cynomorium drip pill as claimed in claim 1, it is characterized in that the described extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis is made by following method: with g or kg is unit, according to the weight portion meter, take by weighing 2 parts of Herba Cynomoriis, 1 part of Fructus Lycii, 1 part of Fructus Schisandrae Chinensis; More than 3 the flavor medical materials, get the Fructus Schisandrae Chinensis vapor distillation, the collection distillate standby; Other gets Herba Cynomorii, Fructus Lycii and Fructus Schisandrae Chinensis medicinal residues and merges, soaked 12 hours, and decocted the 1st time 1.5 hours 2 times, the 2nd time 1 hour, gradation filters, and merging filtrate also adds preceding distillate, is decompressed to 0.1Mpa, under 60 ℃ condition, be condensed into relative density and be 1.3～1.35 thick paste, or continue to make drying, be ground into dry powder, promptly;What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
- 3. compound cynomorium drip pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
- 4. as claim 1 or 3 described any compound cynomorium drip pills, it is characterized in that: describedly contain the extract of Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis etc. 3 flavor active ingredient of Chinese herbs and the mixed proportion of substrate is 1: 1～1: 5.
- 5. the preparation method of a compound cynomorium drip pill is characterized in that being made of following process:5.1 raw material: the extract that contains 3 flavor active ingredient of Chinese herbs such as Herba Cynomorii, Fructus Lycii, Fructus Schisandrae Chinensis;5.2 substrate: Polyethylene Glycol (1000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, above-mentioned carrier one or more mixture wherein;5.3 proportioning: with g or kg is unit, by weight, and Radix Astragali extract: substrate=1: 1～1: 9;5.4, accurately take by weighing Radix Astragali extract and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Radix Astragali extract and substrate and/or emulsion and/or suspension;5.5 adjust the temperature control system of 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 ℃;5.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
- 6. as the preparation method of compound cynomorium drip pill as described in the claim 5, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755439A (en) * | 2012-06-27 | 2012-10-31 | 大连龙康生物科技有限公司 | Medicinal composition for treating impotence and premature ejaculation and preparation method thereof |
| CN114404373A (en) * | 2021-12-22 | 2022-04-29 | 中国科学院西北高原生物研究所 | Cynomorium songaricum chewable tablet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1259363A (en) * | 1999-01-06 | 2000-07-12 | 田养东 | Complex prescription capsule for strengthening yang and tonifying kidney and prepn. method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755439A (en) * | 2012-06-27 | 2012-10-31 | 大连龙康生物科技有限公司 | Medicinal composition for treating impotence and premature ejaculation and preparation method thereof |
| CN114404373A (en) * | 2021-12-22 | 2022-04-29 | 中国科学院西北高原生物研究所 | Cynomorium songaricum chewable tablet and preparation method thereof |
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