CN1660364A - 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method - Google Patents
'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method Download PDFInfo
- Publication number
- CN1660364A CN1660364A CN 200510004946 CN200510004946A CN1660364A CN 1660364 A CN1660364 A CN 1660364A CN 200510004946 CN200510004946 CN 200510004946 CN 200510004946 A CN200510004946 A CN 200510004946A CN 1660364 A CN1660364 A CN 1660364A
- Authority
- CN
- China
- Prior art keywords
- polyethylene glycol
- drug extract
- preparation
- substrate
- inflammatory
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000006187 pill Substances 0.000 title claims abstract description 64
- 238000002360 preparation method Methods 0.000 title claims description 37
- 239000000463 material Substances 0.000 title description 2
- 206010061218 Inflammation Diseases 0.000 title 1
- 230000004054 inflammatory process Effects 0.000 title 1
- 231100000331 toxic Toxicity 0.000 title 1
- 230000002588 toxic effect Effects 0.000 title 1
- 239000003814 drug Substances 0.000 claims abstract description 104
- 206010011224 Cough Diseases 0.000 claims abstract description 7
- 206010068319 Oropharyngeal pain Diseases 0.000 claims abstract description 7
- 201000007100 Pharyngitis Diseases 0.000 claims abstract description 7
- 208000006673 asthma Diseases 0.000 claims abstract description 7
- 229940079593 drug Drugs 0.000 claims description 94
- 239000000284 extract Substances 0.000 claims description 88
- 239000002202 Polyethylene glycol Substances 0.000 claims description 87
- 229920001223 polyethylene glycol Polymers 0.000 claims description 87
- 239000000758 substrate Substances 0.000 claims description 47
- 240000002853 Nelumbo nucifera Species 0.000 claims description 35
- 235000006508 Nelumbo nucifera Nutrition 0.000 claims description 35
- 235000006510 Nelumbo pentapetala Nutrition 0.000 claims description 35
- 241000207961 Sesamum Species 0.000 claims description 35
- 235000003434 Sesamum indicum Nutrition 0.000 claims description 35
- -1 polyoxyethylene stearate Polymers 0.000 claims description 35
- 229920002472 Starch Polymers 0.000 claims description 34
- 235000019698 starch Nutrition 0.000 claims description 34
- 239000008107 starch Substances 0.000 claims description 34
- 230000003110 anti-inflammatory effect Effects 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
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 24
- 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
- 239000000203 mixture Substances 0.000 claims description 19
- 241000746375 Andrographis Species 0.000 claims description 17
- 239000004615 ingredient Substances 0.000 claims description 17
- 239000008194 pharmaceutical composition Substances 0.000 claims description 14
- 239000000843 powder Substances 0.000 claims description 11
- 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
- 229920000159 gelatin Polymers 0.000 claims description 10
- 235000019322 gelatine Nutrition 0.000 claims description 10
- 235000011187 glycerol Nutrition 0.000 claims description 10
- 238000010438 heat treatment Methods 0.000 claims description 10
- 238000004519 manufacturing process Methods 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
- 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
- 235000015424 sodium Nutrition 0.000 claims description 7
- 238000011282 treatment Methods 0.000 claims description 7
- 208000005647 Mumps Diseases 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 210000004072 lung Anatomy 0.000 claims description 6
- 208000010805 mumps infectious disease Diseases 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims description 6
- 210000002784 stomach Anatomy 0.000 claims description 6
- 206010044008 tonsillitis Diseases 0.000 claims description 6
- 239000003053 toxin Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 239000000796 flavoring agent Substances 0.000 claims description 5
- 235000019634 flavors Nutrition 0.000 claims description 5
- 239000012141 concentrate Substances 0.000 claims description 4
- 238000007598 dipping method Methods 0.000 claims description 4
- 239000000839 emulsion Substances 0.000 claims description 4
- 239000000706 filtrate Substances 0.000 claims description 4
- 238000011084 recovery Methods 0.000 claims description 4
- 238000010992 reflux Methods 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 229940126678 chinese medicines Drugs 0.000 claims description 3
- 238000009833 condensation Methods 0.000 claims description 3
- 230000005494 condensation Effects 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 235000003140 Panax quinquefolius Nutrition 0.000 claims description 2
- 240000005373 Panax quinquefolius Species 0.000 claims description 2
- 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
- 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
- 244000118350 Andrographis paniculata Species 0.000 abstract 1
- 241000933211 Helicteres jamaicensis Species 0.000 abstract 1
- 206010034038 Parotitis Diseases 0.000 abstract 1
- 206010001093 acute tonsillitis Diseases 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 description 58
- 229940023488 pill Drugs 0.000 description 24
- 238000002474 experimental method Methods 0.000 description 12
- 239000000969 carrier Substances 0.000 description 9
- 230000000694 effects Effects 0.000 description 7
- 238000005516 engineering process Methods 0.000 description 7
- 238000009472 formulation Methods 0.000 description 7
- 239000004353 Polyethylene glycol 8000 Substances 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- 239000000428 dust Substances 0.000 description 4
- 231100000614 poison Toxicity 0.000 description 3
- 239000003440 toxic substance Substances 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000001754 anti-pyretic effect Effects 0.000 description 2
- 239000000729 antidote Substances 0.000 description 2
- 239000002221 antipyretic Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 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
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 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
- 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
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 229920002701 Polyoxyl 40 Stearate Polymers 0.000 description 1
- 239000004480 active ingredient Substances 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
- 239000008187 granular material Substances 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
- 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
- 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
- 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
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A Chinese medicine in the form of dripping pill for treating cough, asthma, parotitis, acute tonsillitis, sore throat, etc is prepared from green chiretta and narrowleaf screwtree root.
Description
Technical field
The present invention relates to a kind of heat-clearing and toxic substances removing that has, removing heat from blood detumescence effect, being used for the lung stomach has the pharmaceutical composition of containing all disease treatments of the cough and asthma, mumps, tonsillitis, the sore throat pharyngalgia that cause in heat, the fire-toxin, is a kind of drug composition oral preparation that feedstock production forms with two flavor Chinese medicines such as Herba Andrographis dry extractum, Radix Helicteris dry extractum particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The lotus sesame Pianomide that the preparation method that provides among-the B-3977-98 is prepared from, it is a kind of antipyretic and antidote functions that has, be used for the lung stomach oral tablet of containing all disease treatments of the cough and asthma, mumps, tonsillitis, the sore throat pharyngalgia that cause in heat, the fire-toxin is arranged, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Below be drug standard WS
3Prescription that provides among-the B-3977-98 and technology and brief description:
Prescription: Herba Andrographis dry extractum (in total andrographolides) 15g, Radix Helicteris dry extractum 43g
Method for making: above two distinguish the flavor of, and Herba Andrographis dry extractum is to get Folium Andrographis, pulverizes, and uses alcohol dipping three times, and leachate filters, merging filtrate, and recovery ethanol also concentrates and causes the thick paste shape, drying, promptly.Radix Helicteris is got by Radix Helicteris dry extractum system, extracts three times with 60% alcohol heating reflux, and merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, promptly gets (contain moisture and must not cross 5.0%).Get above-mentioned dry extract, add appropriate amount of auxiliary materials, be ground into fine powder, make granule, drying is pressed into 1000, and the bag film-coat promptly.
Function cures mainly: heat-clearing and toxic substances removing, removing heat from blood detumescence; Be used for the lung stomach cough and asthma, mumps, tonsillitis, the sore throat pharyngalgia that Sheng causes in heat, the fire-toxin arranged.
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.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.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 the existing deficiency that the lung stomach has the oral drug preparation of containing all disease treatments of the cough and asthma, mumps, tonsillitis, the sore throat pharyngalgia that cause in heat, the fire-toxin that is used for, a kind of bioavailability height is provided, and has a quick release, quick produce effects, cheap, and free of contamination aborning drug composition oral preparation lotus sesame anti-inflammatory dripping pills.
Lotus sesame anti-inflammatory dripping pills involved in the present invention is a raw material with two flavor Chinese medicines such as Herba Andrographis dry extractum, Radix Helicteris dry extractum, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain lotus sesame anti-inflammatory dripping pills involved in the present invention:
[preparation method]
1. raw material: Herba Andrographis dry extractum (in total andrographolides) 150g, Radix Helicteris dry extractum 430g, be ground into dry powder, mix homogeneously, the drug extract dry powder that obtains containing total andrographolides and Radix Helicteris effective ingredient is standby;
2. substrate: Polyethylene Glycol
(2000～20000), one or more the mixture in pharmaceutically suitable carrier such as 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 drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug 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, 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, 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 1: a kind of preparation method of Herba Andrographis dry extractum] gets Folium Andrographis, pulverizes, and uses alcohol dipping three times, and leachate filters, merging filtrate, and recovery ethanol also concentrates and causes the thick paste shape, drying, promptly.
[appendix 2: a kind of preparation method of Radix Helicteris dry extractum] gets Radix Helicteris, extracts three times with 60% alcohol heating reflux, and merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, promptly gets (contain moisture and must not cross 5.0%).
Appendix 1,2 has only provided a kind of method for preparing dry extract commonly used, is not limited to this a kind of method during actual enforcement.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The lotus sesame Pianomide that the preparation method that provides among-the B-3977-98 is prepared from, it is a kind of antipyretic and antidote functions that has, be used for the lung stomach oral tablet of containing all disease treatments of the cough and asthma, mumps, tonsillitis, the sore throat pharyngalgia that cause in heat, the fire-toxin is arranged, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of 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.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.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.
Lotus sesame anti-inflammatory dripping pills involved in the present invention is compared with lotus sesame Pianomide has following beneficial effect:
1. lotus sesame anti-inflammatory dripping pills involved in the present invention; utilize surfactant to be substrate; the extract of pharmaceutically active ingredient is made solid dispersion in containing two flavors such as Herba Taraxaci, Radix Scutellariae; 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. lotus sesame anti-inflammatory dripping pills 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. lotus sesame anti-inflammatory dripping pills 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 lotus sesame anti-inflammatory dripping pills of the present invention.
First group: the test of single-matrix
1. raw material: Herba Andrographis dry extractum (in total andrographolides) 150g, Radix Helicteris dry extractum 430g, be ground into dry powder, mix homogeneously, the drug extract dry powder that obtains containing total andrographolides and Radix Helicteris effective ingredient is standby
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), one or more the mixture in pharmaceutically suitable carrier such as 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 drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the lotus sesame anti-inflammatory dripping pills of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared lotus sesame anti-inflammatory dripping pills in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared lotus sesame anti-inflammatory dripping pills in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared lotus sesame anti-inflammatory dripping pills in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. raw material: Herba Andrographis dry extractum (in total andrographolides) 150g, Radix Helicteris dry extractum 430g, be ground into dry powder, mix homogeneously, the drug extract dry powder that obtains containing total andrographolides and Radix Helicteris effective ingredient is standby
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 drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the lotus sesame anti-inflammatory dripping pills of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared lotus sesame anti-inflammatory dripping pills 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, adopt homemade drop pill machine, 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 experimental results and see 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 2000 | ?????50.0 | ????60 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ?????50.0 | ????76 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ?????50.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ?????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ?????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ?????50.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ?????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ?????50.0 | ????68 | ????＜30 | ????＞10 | + |
| Poloxamer | ?????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ?????50.0 | ????73 | ????＜30 | ????＞10 | + |
| Sodium lauryl sulphate | ?????50.0 | ????66 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ?????50.0 | ????54 | ????＞30 | ????＞10 | ++ |
| Sodium stearate | ?????50.0 | ????54 | ????＞30 | ????＞10 | ++ |
| Glycerin gelatine | ?????50.0 | ????53 | ????＞30 | ????＞10 | + |
| Lac | ?????50.0 | ????52 | ????＞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 2000 | ????25.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????70 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????70 | ????＞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 2000 | ????10.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????86 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????92 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????79 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????75 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????72 | ????＞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 | ????84 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????82 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????79 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????72 | ????＜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 | ????88 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????82 | ????＜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 | ????88 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????86 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????83 | ????＜30 | ????＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????80 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????86 | ????＜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 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????1?0 | ????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 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????84 | ????＜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 | ????92 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜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 (9)
1. one kind is used for the pharmaceutical composition lotus sesame anti-inflammatory dripping pills that the lung stomach has all disease treatments of cough and asthma, mumps, tonsillitis, sore throat pharyngalgia that Sheng causes in heat, the fire-toxin, with two flavor Chinese medicines such as Herba Andrographis dry extractum, Radix Helicteris dry extractum is raw material, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 raw material: in total andrographolides, get Herba Andrographis dry extractum 150g, Radix Helicteris dry extractum 430g, be ground into dry powder, mix homogeneously obtains containing the drug extract dry powder of total andrographolides and Radix Helicteris effective ingredient;
1.2 substrate: Polyethylene Glycol
(2000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
1.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. lotus sesame anti-inflammatory dripping pills as claimed in claim 1 is characterized in that the preparation method of described Herba Andrographis dry extractum is as follows: get Folium Andrographis, pulverize, use alcohol dipping three times, leachate filters, merging filtrate, and recovery ethanol also concentrates and causes the thick paste shape, drying, promptly.
3. lotus sesame anti-inflammatory dripping pills as claimed in claim 1 is characterized in that the preparation method of described Radix Helicteris dry extractum is as follows: get Radix Helicteris, extract three times with 60% alcohol heating reflux, merge extractive liquid, reclaims ethanol and is concentrated into the thick paste shape, promptly.
4. lotus sesame anti-inflammatory dripping pills 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.
5. as claim 1, or 2, or 3, or 4 described any lotus sesame anti-inflammatory dripping pills, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
6. the preparation method of a lotus sesame anti-inflammatory dripping pills is characterized in that being made of following process:
6.1, get Herba Andrographis dry extractum 150g, Radix Helicteris dry extractum 430g in total andrographolides, be ground into dry powder, mix homogeneously obtains containing the drug extract dry powder of total andrographolides and Radix Helicteris effective ingredient;
6.2 substrate: Polyethylene Glycol
(2000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
6.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
6.4, accurately take by weighing drug 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 drug extract and substrate and/or emulsion and/or suspension;
6.5 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) ℃;
6.6 treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, shrink molding promptly.
7. the preparation method of lotus sesame anti-inflammatory dripping pills as claimed in claim 6 is characterized in that the preparation method of described Herba Andrographis dry extractum is as follows: get Folium Andrographis, pulverize, with alcohol dipping three times, leachate filters, merging filtrate, recovery ethanol also concentrates and causes the thick paste shape, drying, promptly.
8. the preparation method of lotus sesame anti-inflammatory dripping pills as claimed in claim 1, the preparation method that it is characterized in that described Radix Helicteris dry extractum is as follows: get Radix Helicteris, extract three times merge extractive liquid, with 60% alcohol heating reflux, reclaim ethanol and be concentrated into the thick paste shape, promptly.
9. as the preparation method of lotus sesame anti-inflammatory dripping pills as described in the claim 6, it is characterized in that: method 6.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510004946 CN1660364A (en) | 2005-01-31 | 2005-01-31 | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510004946 CN1660364A (en) | 2005-01-31 | 2005-01-31 | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1660364A true CN1660364A (en) | 2005-08-31 |
Family
ID=35010101
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510004946 Pending CN1660364A (en) | 2005-01-31 | 2005-01-31 | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1660364A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102327313A (en) * | 2011-09-23 | 2012-01-25 | 江西普正制药有限公司 | Preparation method of Lianzhi anti-inflammation soft capsule |
| CN102824380A (en) * | 2012-09-18 | 2012-12-19 | 南京正亮医药科技有限公司 | Application of Lianzhi anti-inflammation dropping pills in preparing medicine for suppressing HT1080 cell proliferation |
| CN107823152A (en) * | 2017-11-09 | 2018-03-23 | 重庆科瑞南海制药有限责任公司 | A kind of preparation method of lotus sesame sulfathiazole |
-
2005
- 2005-01-31 CN CN 200510004946 patent/CN1660364A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102327313A (en) * | 2011-09-23 | 2012-01-25 | 江西普正制药有限公司 | Preparation method of Lianzhi anti-inflammation soft capsule |
| CN102824380A (en) * | 2012-09-18 | 2012-12-19 | 南京正亮医药科技有限公司 | Application of Lianzhi anti-inflammation dropping pills in preparing medicine for suppressing HT1080 cell proliferation |
| CN102824380B (en) * | 2012-09-18 | 2013-11-06 | 南京正亮医药科技有限公司 | Application of Lianzhi anti-inflammation dropping pills in preparing medicine for suppressing HT1080 cell proliferation |
| CN107823152A (en) * | 2017-11-09 | 2018-03-23 | 重庆科瑞南海制药有限责任公司 | A kind of preparation method of lotus sesame sulfathiazole |
| CN107823152B (en) * | 2017-11-09 | 2020-02-11 | 重庆科瑞南海制药有限责任公司 | Preparation method of lotus seed and ganoderma lucidum anti-inflammation tablets |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1660368A (en) | Oral drop pill in use for clearing away heat and toxic material and preparation method | |
| CN1307979C (en) | Hemostatic beautyberry dripping pill and its preparing method | |
| CN1316961C (en) | Grosvenor's momordica fruit drip pill an dits preparation method | |
| CN100341487C (en) | 'Shuanghuang' antiphlogistic drop pill in use relieving inflammation and preparation method | |
| CN1316963C (en) | Yunnan begonia herb drip pill and its preparation method | |
| CN1660364A (en) | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method | |
| CN1660316A (en) | Drop pills preparation in use for treating bronchitis and preparation method | |
| CN1686342A (en) | Herminium drip pill and its preparation method | |
| CN1307983C (en) | Mai-an dripping pill for treating hyperlipoproteinemia and its preparing method | |
| CN1316962C (en) | Cough panting quieting drip pill and its preparation method | |
| CN1686479A (en) | Loquat drip pill for treating cough and its preparation method | |
| CN1698822A (en) | Gansu dripping pill for treating hepatitis and preparation method thereof | |
| CN1709413A (en) | Golden gallbladder-normalizing dropping pill for relaxing-liver and normalizing gallbladder, and its preparing method | |
| CN1660373A (en) | Bistort drop pill and preparation method | |
| CN1301095C (en) | 'Yinchai' drop pills for treating cold, fever and cough and preparation method | |
| CN1682817A (en) | Throat dripping pill for clearing away heat and toxic material and its preparing method | |
| CN1686452A (en) | Two kinds of oral drip pills for treating tracheitis and its preparation method | |
| CN1686382A (en) | Throat clearing drip pill and its preparation method | |
| CN1698780A (en) | Dripping pills for treating all kinds of rhinitis and its preparation method | |
| CN1686381A (en) | Jaundice capillaris drip pill and its preparation method | |
| CN1660371A (en) | Oral drop pills in use for treating diseases of bacterial infection and preparation method | |
| CN1679675A (en) | Chuanhuang anti-inflammation drops for clearing away heat and detoxicating, and preparation thereof | |
| CN1686453A (en) | Child cough panting drip pill and its preparation method | |
| CN1686454A (en) | Xiaoke drip pill used for suppressing cough and transforming phlegm and its preparation method | |
| CN1686477A (en) | Lonicera flower mango drip pill and its preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |