CN1686452A - Two kinds of oral drip pills for treating tracheitis and its preparation method - Google Patents
Two kinds of oral drip pills for treating tracheitis and its preparation method Download PDFInfo
- Publication number
- CN1686452A CN1686452A CN 200510069301 CN200510069301A CN1686452A CN 1686452 A CN1686452 A CN 1686452A CN 200510069301 CN200510069301 CN 200510069301 CN 200510069301 A CN200510069301 A CN 200510069301A CN 1686452 A CN1686452 A CN 1686452A
- Authority
- CN
- China
- Prior art keywords
- polyethylene glycol
- substrate
- extract
- drop pill
- drug extract
- 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.)
- Granted
Links
- 239000006187 pill Substances 0.000 title claims abstract description 61
- 238000002360 preparation method Methods 0.000 title claims description 28
- 206010044302 Tracheitis Diseases 0.000 title description 3
- 238000000034 method Methods 0.000 claims abstract description 24
- 206010006458 Bronchitis chronic Diseases 0.000 claims abstract description 8
- 206010006451 bronchitis Diseases 0.000 claims abstract description 8
- 208000007451 chronic bronchitis Diseases 0.000 claims abstract description 8
- 206010011224 Cough Diseases 0.000 claims abstract description 7
- 239000003814 drug Substances 0.000 claims description 111
- 239000000284 extract Substances 0.000 claims description 97
- 229920001223 polyethylene glycol Polymers 0.000 claims description 92
- 239000002202 Polyethylene glycol Substances 0.000 claims description 88
- 229940079593 drug Drugs 0.000 claims description 88
- 239000000758 substrate Substances 0.000 claims description 50
- -1 sorbitol anhydride Chemical class 0.000 claims description 48
- 206010062717 Increased upper airway secretion Diseases 0.000 claims description 34
- 208000026435 phlegm Diseases 0.000 claims description 34
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 32
- 229920001983 poloxamer Polymers 0.000 claims description 32
- 229960000502 poloxamer Drugs 0.000 claims description 32
- 150000002148 esters Chemical class 0.000 claims description 31
- 229920002472 Starch Polymers 0.000 claims description 30
- 235000019698 starch Nutrition 0.000 claims description 30
- 239000008107 starch Substances 0.000 claims description 30
- 208000000059 Dyspnea Diseases 0.000 claims description 29
- 206010013975 Dyspnoeas Diseases 0.000 claims description 29
- 229920000858 Cyclodextrin Polymers 0.000 claims description 25
- 239000001116 FEMA 4028 Substances 0.000 claims description 25
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 25
- 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 25
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims description 25
- 229960004853 betadex Drugs 0.000 claims description 25
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 25
- 239000011734 sodium Substances 0.000 claims description 25
- 229910052708 sodium Inorganic materials 0.000 claims description 25
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 22
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 22
- 239000008186 active pharmaceutical agent Substances 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 16
- 239000008194 pharmaceutical composition Substances 0.000 claims description 15
- 239000001828 Gelatine Substances 0.000 claims description 11
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 11
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 11
- 235000021355 Stearic acid Nutrition 0.000 claims description 11
- 229920000159 gelatin Polymers 0.000 claims description 11
- 235000019322 gelatine Nutrition 0.000 claims description 11
- 235000011187 glycerol Nutrition 0.000 claims description 11
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 11
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 11
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 11
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 11
- 239000008117 stearic acid Substances 0.000 claims description 11
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 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 8
- 239000000600 sorbitol Substances 0.000 claims description 8
- 239000002994 raw material Substances 0.000 claims description 7
- 238000010438 heat treatment Methods 0.000 claims description 6
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 239000000839 emulsion Substances 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 238000010992 reflux Methods 0.000 claims description 4
- 235000015424 sodium Nutrition 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 238000009833 condensation Methods 0.000 claims description 3
- 230000005494 condensation Effects 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 239000000047 product Substances 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 206010013786 Dry skin Diseases 0.000 claims description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 2
- 238000005903 acid hydrolysis reaction Methods 0.000 claims description 2
- 238000001816 cooling Methods 0.000 claims description 2
- 239000000706 filtrate Substances 0.000 claims description 2
- 239000000796 flavoring agent Substances 0.000 claims description 2
- 235000019634 flavors Nutrition 0.000 claims description 2
- 239000000413 hydrolysate Substances 0.000 claims description 2
- 229940057995 liquid paraffin Drugs 0.000 claims description 2
- 238000000465 moulding Methods 0.000 claims description 2
- 238000004064 recycling Methods 0.000 claims description 2
- 229920002545 silicone oil Polymers 0.000 claims description 2
- 238000003756 stirring Methods 0.000 claims description 2
- 235000011149 sulphuric acid Nutrition 0.000 claims description 2
- 239000001117 sulphuric acid Substances 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
- 208000006673 asthma Diseases 0.000 abstract description 2
- 241000219506 Phytolacca Species 0.000 abstract 1
- 206010036790 Productive cough Diseases 0.000 abstract 1
- 241000219784 Sophora Species 0.000 abstract 1
- 229940126678 chinese medicines Drugs 0.000 abstract 1
- 208000024794 sputum Diseases 0.000 abstract 1
- 210000003802 sputum Anatomy 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 description 58
- 229940023488 pill Drugs 0.000 description 45
- 238000002474 experimental method Methods 0.000 description 21
- 239000004615 ingredient Substances 0.000 description 12
- 239000000969 carrier Substances 0.000 description 9
- 238000009472 formulation Methods 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 description 7
- 238000002156 mixing Methods 0.000 description 7
- 230000000694 effects Effects 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- ZSBXGIUJOOQZMP-UHFFFAOYSA-N Isomatrine Natural products C1CCC2CN3C(=O)CCCC3C3C2N1CCC3 ZSBXGIUJOOQZMP-UHFFFAOYSA-N 0.000 description 4
- ZSBXGIUJOOQZMP-JLNYLFASSA-N Matrine Chemical compound C1CC[C@H]2CN3C(=O)CCC[C@@H]3[C@@H]3[C@H]2N1CCC3 ZSBXGIUJOOQZMP-JLNYLFASSA-N 0.000 description 4
- 239000000428 dust Substances 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 229930014456 matrine Natural products 0.000 description 4
- 230000001088 anti-asthma Effects 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 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
- 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
- 239000002585 base 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
- 239000000463 material Substances 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
- 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)
Abstract
Two Chinese medicines 'Tanjing dripping pill' and 'Tanchuan dripping pill' for treating cough with sputum, asthma, chronic bronchitis, etc is prepared from phytolacca root, flavescent sophora root and medicinal carrier. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to two kinds have cough-relieving, eliminate the phlegm, antiasthmatic effect, be used for the pharmaceutical composition of chronic bronchitis treatment, be the drug composition oral preparation that feedstock production forms particularly with Chinese medicine Radix phytolaccae extract or matrine dry extract.
Background technology
Drug standard WS promulgated by the ministries or commissions of the Central Government
3Among TANJING sheet that publishes among-the B-2446-97 and the national drug standards WS-11522 (ZD-1522)-2002 publication the phlegm dyspnea sheet, all be have cough-relieving, eliminate the phlegm, antiasthmatic effect, the oral tablet that is used for the chronic bronchitis treatment, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be the brief description of these two kinds of oral formulations:
1. nomenclature of drug: TANJING sheet
Prescription: Radix phytolaccae extract 15g
Method for making: get Radix phytolaccae extract 15g, add right amount of auxiliary materials, make granule, be pressed into 1000, promptly;
Function cures mainly: expelling phlegm for arresting cough; Be used for the treatment of chronic tracheitis, especially senile tracheitis.
2. nomenclature of drug: phlegm dyspnea sheet
Prescription: matrine dry extract 75g, starch 25g
Method for making: get matrine dry extract, be ground into fine powder, add starch, mixing is made granule, tabletting, promptly;
Function cures mainly: cough-relieving, eliminate the phlegm, relieving asthma.Be used for chronic bronchitis.
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 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 the existing deficiency that is used for the oral drug preparation of chronic bronchitis treatment, two kinds of bioavailability height are provided, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations TANJING drop pill and phlegm dyspnea drop pill.TANJING drop pill involved in the present invention or phlegm dyspnea drop pill are raw material with the extract that contains Chinese medicine trade route or Radix Sophorae Flavescentis active pharmaceutical ingredient respectively, are prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain TANJING drop pill involved in the present invention or phlegm dyspnea drop pill:
[preparation method]
1. raw material: contain the extract of Chinese medicine trade route active pharmaceutical ingredient, or contain the extract of Radix Sophorae Flavescentis active pharmaceutical ingredient;
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, drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, base is placed in the heating container heating while stirring, standby until the fused solution of extract that obtains containing Chinese medicine trade route or Radix Sophorae Flavescentis active pharmaceutical ingredient 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 active pharmaceutical ingredient extract and substrate and/or emulsion and/or suspension places in the dropping-pill machine head jar, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix 1: the preparation of trade route extract]
Get the trade route and be ground into coarse powder, add alcohol reflux 3 times, each 3 hours, merge ethanol liquid, filter, reclaim ethanol, extractum adds sulphuric acid hydrolysis, and hydrolysate adds 70% ethanol, makes wet product, oven dry, promptly.
[appendix 2: the preparation of matrine dry extract]
Get Radix Sophorae Flavescentis, be ground into coarse powder, add 85% alcohol reflux 3 times, the 1st, 2 time each 2 hours, the 3rd time 1 hour, merge 3 times extracting solution, filter, filtrate recycling ethanol does not extremely have the alcohol flavor, is concentrated into the thick paste that relative density is 1.35-1.40, puts 60 ℃ of dryings down, promptly.
[beneficial effect]
Drug standard WS promulgated by the ministries or commissions of the Central Government
3Among TANJING sheet that publishes among-the B-2446-97 and the national drug standards WS-11522 (ZD-1522)-2002 publication the phlegm dyspnea sheet, all be have cough-relieving, eliminate the phlegm, antiasthmatic effect, the oral tablet that is used for the chronic bronchitis treatment, 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.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.
TANJING drop pill involved in the present invention or phlegm dyspnea drop pill, its corresponding tablet are compared has following beneficial effect:
1. TANJING drop pill involved in the present invention or phlegm dyspnea drop pill; utilize surfactant to be substrate; make solid dispersion with the extract that contains Chinese medicine trade route or Radix Sophorae Flavescentis active pharmaceutical ingredient; 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. TANJING drop pill involved in the present invention or phlegm dyspnea drop pill, 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. TANJING drop pill involved in the present invention or phlegm dyspnea drop pill mix the extract that contains active constituents of medicine mutually with molten matrix, splash in the not miscible condensed fluid and make.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 TANJING drop pill of the present invention or phlegm dyspnea drop pill.
[first group: the test of single-matrix]
1. raw material: the extract that contains Chinese medicine trade route or Radix Sophorae Flavescentis active pharmaceutical ingredient that makes according to [appendix 1] or [appendix 2];
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can get the TANJING drop pill or the phlegm dyspnea drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared TANJING or phlegm dyspnea drop 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 span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared TANJING or phlegm dyspnea drop 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 span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared TANJING or phlegm dyspnea drop 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 span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: the extract that contains Chinese medicine trade route or Radix Sophorae Flavescentis active pharmaceutical ingredient that makes according to [appendix 1] or [appendix 2];
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 get the TANJING drop pill or the phlegm dyspnea drop pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 TANJING or phlegm dyspnea drop 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 | ??72 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 6000 | ??50.0 | ??85 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 10000 | ??50.0 | ??85 | ??＜30 | ??＞10 | ??++ |
| Polyethylene Glycol 20000 | ??50.0 | ??84 | ??＜30 | ??＞10 | ??++ |
| Span 40 | ??50.0 | ??69 | ??＜30 | ??＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ??50.0 | ??78 | ??＜30 | ??＞10 | ??++ |
| Poloxamer | ??50.0 | ??82 | ??＜30 | ??＞10 | ??++ |
| Sodium lauryl sulphate | ??50.0 | ??78 | ??＞30 | ??＞10 | ??++ |
| Stearic acid | ??50.0 | ??70 | ??＞30 | ??＞10 | ??++ |
| Sodium stearate | ??50.0 | ??67 | ??＞30 | ??＞10 | ??++ |
| Glycerin gelatine | ??50.0 | ??66 | ??＞30 | ??＞10 | ??+ |
| Lac | ??50.0 | ??66 | ??＞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 | ??79 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??25.0 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??25.0 | ??77 | ??＜30 | ??＞10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??25.0 | ??89 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??25.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??25.0 | ??79 | ??＜30 | ??＞10 | ??++ |
| Stearic acid | ??25.0 | ??78 | ??＞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 | ??85 | ??＜30 | ??＞10 | ??+ |
| Polyethylene Glycol 4000 | ??10.0 | ??92 | ??＜30 | ??＜10 | ??++ |
| Polyethylene Glycol 6000 | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 10000 | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Polyethylene Glycol 20000 | ??10.0 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Span 40 | ??10.0 | ??79 | ??＜30 | ??＜10 | ??+++ |
| Polyoxyethylene stearate 40 esters | ??10.0 | ??90 | ??＜30 | ??＜10 | ??++ |
| Poloxamer | ??10.0 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Sodium lauryl sulphate | ??10.0 | ??82 | ??＜30 | ??＞10 | ??+++ |
| Stearic acid | ??10.0 | ??79 | ??＞30 | ??＞10 | ??+++ |
| Sodium stearate | ??10.0 | ??75 | ??＞30 | ??＞10 | ??+++ |
| Glycerin gelatine | ??10.0 | ??76 | ??＞30 | ??＞10 | ??+++ |
| Lac | ??10.0 | ??75 | ??＞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 | ??85 | ??＜30 | ??＞10 | ??++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??50 | ??83 | ??＜30 | ??＞10 | ??++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??50 | ??80 | ??＜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 | ??85 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ??10 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ??10 | ??85 | ??＜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 | ??90 | ??＜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 | ??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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??25 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ??25 | ??89 | ??＜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 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ??10 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ??10 | ??90 | ??＜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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??50 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??50 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??50 | ??88 | ??＜30 | ??＞10 | ??+++ |
The group practices of table 11 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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??25 | ??89 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??25 | ??88 | ??＜30 | ??＜10 | ??+++ |
The group practices of table 12 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 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ??10 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ??10 | ??89 | ??＜30 | ??＜10 | ??+++ |
1. can be seen by the result in the table: when the ratio of 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 (8)
1. a pharmaceutical composition TANJING drop pill that is used for the chronic bronchitis treatment is a raw material with the extract that contains Chinese medicine trade route active pharmaceutical ingredient, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 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;
1.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. TANJING drop pill as claimed in claim 1, it is characterized in that the described extract that contains Chinese medicine trade route active pharmaceutical ingredient is made by following method: get the trade route and be ground into coarse powder, add alcohol reflux 3 times, each 3 hours, merge ethanol liquid, filter, reclaim ethanol, extractum adds sulphuric acid hydrolysis, hydrolysate adds 70% ethanol, make wet product, oven dry, promptly.
3. a pharmaceutical composition phlegm dyspnea drop pill that is used for the chronic bronchitis treatment is a raw material with the extract that contains Chinese medicine Radix Sophorae Flavescentis active pharmaceutical ingredient, be prepared from pharmaceutically suitable carrier as substrate, wherein:
3.1 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;
3.2 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
4. phlegm dyspnea drop pill as claimed in claim 3, it is characterized in that the described extract that contains Chinese medicine Radix Sophorae Flavescentis active pharmaceutical ingredient is made by following method: get Radix Sophorae Flavescentis, be ground into coarse powder, add 85% alcohol reflux 3 times, 1st, 2 times each 2 hours, the 3rd time 1 hour, merge 3 times extracting solution, filter, filtrate recycling ethanol is to there not being the alcohol flavor, be concentrated into the thick paste that relative density is 1.35-1.40, put 60 ℃ of dryings down, promptly.
5. TANJING drop pill as claimed in claim 1 or phlegm dyspnea drop pill as claimed in claim 3 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.
6. as claim 1 or 3 or 5 described any drop pill, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
7. the preparation method of TANJING or phlegm dyspnea drop pill is characterized in that being made of following process:
7.1 raw material: contain the extract of Chinese medicine trade route active pharmaceutical ingredient, or contain the extract of Radix Sophorae Flavescentis active pharmaceutical ingredient;
7.2 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;
7.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
7.4 according to the given ratio of prescription, accurately take by weighing drug extract and substrate, base is placed in the heating container heating while stirring, standby until the fused solution of extract that obtains containing Chinese medicine trade route or Radix Sophorae Flavescentis active pharmaceutical ingredient and substrate and/or emulsion and/or suspension;
7.5 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 ℃;
7.6 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 active pharmaceutical ingredient extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
8. as the preparation method of cough-relieving drop pills as described in the claim 7, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100693010A CN100348177C (en) | 2005-05-13 | 2005-05-13 | Two kinds of oral drip pills for treating tracheitis and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100693010A CN100348177C (en) | 2005-05-13 | 2005-05-13 | Two kinds of oral drip pills for treating tracheitis and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1686452A true CN1686452A (en) | 2005-10-26 |
| CN100348177C CN100348177C (en) | 2007-11-14 |
Family
ID=35304494
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100693010A Expired - Fee Related CN100348177C (en) | 2005-05-13 | 2005-05-13 | Two kinds of oral drip pills for treating tracheitis and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100348177C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008517B (en) * | 2007-07-26 | 2012-05-09 | 陕西同康药业有限公司 | Process for producing purified water of Chinese medicine phytolacca extract |
| CN111686051A (en) * | 2020-07-27 | 2020-09-22 | 浙江爱尚日用品有限公司 | Plant toothpaste for preventing and treating halitosis |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1247241C (en) * | 2003-11-12 | 2006-03-29 | 北京正大绿洲医药科技有限公司 | Liuwei Dihuang dripping pills and its preparation |
-
2005
- 2005-05-13 CN CNB2005100693010A patent/CN100348177C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008517B (en) * | 2007-07-26 | 2012-05-09 | 陕西同康药业有限公司 | Process for producing purified water of Chinese medicine phytolacca extract |
| CN111686051A (en) * | 2020-07-27 | 2020-09-22 | 浙江爱尚日用品有限公司 | Plant toothpaste for preventing and treating halitosis |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100348177C (en) | 2007-11-14 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1301098C (en) | Hairy holly root drip pill and its preparation method | |
| CN1686478A (en) | Cough suppressing phlegm transforming drip pill and its preparation 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 | |
| CN1301096C (en) | Cordyceps drip pill used for nourishing lung and kidney and its preparation method | |
| CN1660316A (en) | Drop pills preparation in use for treating bronchitis and preparation method | |
| CN1686452A (en) | Two kinds of oral drip pills for treating tracheitis and its preparation method | |
| CN1686480A (en) | Cough asthma stoppig drip pill and its preparation method | |
| CN1686342A (en) | Herminium drip pill and its preparation method | |
| CN1709419A (en) | Basis-reinforcing eyesight-improving dropping pill for treating eye disease and its preparing method | |
| CN1307985C (en) | Melastome drip pill and its preparation method | |
| CN1307981C (en) | Xuening dripping pill having hemostatic function and its preparing method | |
| CN1698822A (en) | Gansu dripping pill for treating hepatitis and preparation method thereof | |
| CN1686436A (en) | Oral drip pill used for cough suppressing phlegm transforming and its preparation method | |
| CN1660364A (en) | 'Lianzhi' anti inflammation drop pill in use for clearing away heat and toxic material and preparation method | |
| CN1686440A (en) | Yunnan begonia herb drip pill and its preparation method | |
| CN1709413A (en) | Golden gallbladder-normalizing dropping pill for relaxing-liver and normalizing gallbladder, and its preparing method | |
| CN1686479A (en) | Loquat drip pill for treating cough and its preparation method | |
| CN1307982C (en) | Maishu dripping pill for reducing blood fat and its preparing method | |
| CN1660373A (en) | Bistort drop pill and preparation method | |
| CN1686454A (en) | Xiaoke drip pill used for suppressing cough and transforming phlegm and its preparation method | |
| CN1686521A (en) | Psoriasis drip pill and its preparation method | |
| CN1682817A (en) | Throat dripping pill for clearing away heat and toxic material and its preparing method | |
| CN1686382A (en) | Throat clearing drip pill and its preparation method | |
| CN1686340A (en) | Gastrodia brain arousing drip pill for nourishing liver and kidney 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 | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20071114 |