CN1698781A - Cold treating dripping pills and its preparation method - Google Patents
Cold treating dripping pills and its preparation method Download PDFInfo
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- CN1698781A CN1698781A CN 200510072175 CN200510072175A CN1698781A CN 1698781 A CN1698781 A CN 1698781A CN 200510072175 CN200510072175 CN 200510072175 CN 200510072175 A CN200510072175 A CN 200510072175A CN 1698781 A CN1698781 A CN 1698781A
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- Prior art keywords
- polyethylene glycol
- substrate
- drop pill
- extract
- shangfengjing
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- 239000006187 pill Substances 0.000 title claims abstract description 48
- 238000002360 preparation method Methods 0.000 title claims description 31
- 239000003814 drug Substances 0.000 claims abstract description 103
- 239000000284 extract Substances 0.000 claims abstract description 90
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims abstract description 19
- 239000000203 mixture Substances 0.000 claims abstract description 13
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 10
- 235000008216 herbs Nutrition 0.000 claims abstract description 9
- 229920001223 polyethylene glycol Polymers 0.000 claims description 91
- 239000002202 Polyethylene glycol Substances 0.000 claims description 88
- 229940079593 drug Drugs 0.000 claims description 86
- 239000000758 substrate Substances 0.000 claims description 47
- -1 sorbitol anhydride Chemical class 0.000 claims description 44
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 31
- 229920001983 poloxamer Polymers 0.000 claims description 31
- 229960000502 poloxamer Drugs 0.000 claims description 31
- 150000002148 esters Chemical class 0.000 claims description 30
- 241000628997 Flos Species 0.000 claims description 29
- 229920002472 Starch Polymers 0.000 claims description 27
- 235000019698 starch Nutrition 0.000 claims description 27
- 239000008107 starch Substances 0.000 claims description 27
- 229920000858 Cyclodextrin Polymers 0.000 claims description 24
- 239000001116 FEMA 4028 Substances 0.000 claims description 24
- 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 24
- 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 24
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims description 24
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- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 24
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- 239000008194 pharmaceutical composition Substances 0.000 claims description 14
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- 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
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- 235000011187 glycerol Nutrition 0.000 claims description 10
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 10
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 10
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 10
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 10
- 239000008117 stearic acid Substances 0.000 claims description 10
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- 239000004480 active ingredient Substances 0.000 claims description 8
- 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 6
- 239000007864 aqueous solution Substances 0.000 claims description 6
- 238000010438 heat treatment Methods 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims description 6
- 239000000600 sorbitol Substances 0.000 claims description 6
- 239000000341 volatile oil Substances 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 5
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 4
- 239000000839 emulsion Substances 0.000 claims description 4
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- 239000000843 powder Substances 0.000 claims description 4
- 238000004321 preservation Methods 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- 241000218378 Magnolia Species 0.000 claims description 3
- 238000009833 condensation Methods 0.000 claims description 3
- 230000005494 condensation Effects 0.000 claims description 3
- 238000004821 distillation Methods 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 235000015424 sodium Nutrition 0.000 claims description 3
- 238000001256 steam distillation Methods 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 2
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- 238000000465 moulding Methods 0.000 claims description 2
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- 239000000470 constituent Substances 0.000 abstract description 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 abstract 1
- 241001633683 Centipeda <firmicute> Species 0.000 abstract 1
- 235000008495 Chrysanthemum leucanthemum Nutrition 0.000 abstract 1
- 244000035851 Chrysanthemum leucanthemum Species 0.000 abstract 1
- 241000218394 Magnolia liliiflora Species 0.000 abstract 1
- 241000208969 Securidaca diversifolia Species 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
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- 201000009240 nasopharyngitis Diseases 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 description 58
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- 239000004615 ingredient Substances 0.000 description 12
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- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 description 7
- 238000005516 engineering process Methods 0.000 description 7
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- 206010028748 Nasal obstruction Diseases 0.000 description 5
- 239000007921 spray Substances 0.000 description 5
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- 239000008186 active pharmaceutical agent Substances 0.000 description 3
- 229920001214 Polysorbate 60 Polymers 0.000 description 2
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- 229960001617 ethyl hydroxybenzoate Drugs 0.000 description 2
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 2
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 2
- 238000010579 first pass effect Methods 0.000 description 2
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- 238000005469 granulation Methods 0.000 description 2
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- 235000015250 liver sausages Nutrition 0.000 description 2
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- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000011200 topical administration Methods 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 1
- MYMOFIZGZYHOMD-UHFFFAOYSA-N Dioxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 102000000340 Glucosyltransferases Human genes 0.000 description 1
- 108010055629 Glucosyltransferases Proteins 0.000 description 1
- 241001640034 Heteropterys Species 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 229920002701 Polyoxyl 40 Stearate Polymers 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
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- 235000001727 glucose Nutrition 0.000 description 1
- 125000002791 glucosyl group Chemical class C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 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
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- 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
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- Medicinal Preparation (AREA)
Abstract
Disclosed is a dripping pill for treating stuffy nose with nasal discharge caused by common cold. The objective of the invention is to provide a medicinal composition having the advantages of high biological availability, quick-speed medicine release, quick-speed effect, higher medicinal content, easy administration, and low price. The drop pill is prepared from the extract containing the active constituent of the four Chinese medicinal herbs, i.e. flower bud of lily magnolia, wild chrysanthemum flower, centipeda, and menthol, and medicinal carrying agent as the base material.
Description
Technical field
The present invention relates to a kind of dispelling wind to relieve the exterior syndrome that has, the sensible effect of heat clearing away, be used to the catch a cold pharmaceutical composition of treatment for diseases such as the nasal obstruction that causes, watery nasal discharge is a kind of drug composition oral preparation that feedstock production forms to contain 4 flavor active ingredient of Chinese herbs extracts such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum particularly.
Background technology
The Shangfengjing spray that is prepared from according to the preparation method that provides among the national drug standards WS-11194 (ZD-1194)-2002, it is a kind of dispelling wind to relieve the exterior syndrome that has, the sensible effect of heat clearing away, the oral cavity external preparation of treatment for diseases such as the nasal obstruction that causes, watery nasal discharge is used to catch a cold, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be prescription and technology and the brief description that provides among the drug standard WS-11194 (ZD-1194)-2002:
Prescription: Flos Magnoliae 100g, Flos Chrysanthemi Indici 100g, Herba Centipedae 75g, Mentholum 0.06g, polyoxyethylene sorbitan monoleate 10g, ethylparaben 1g
Method for making: above four Chinese medicine, except that Mentholum, three flavors such as all the other Flos Magnoliaes extract volatile oil with steam distillation, add polyoxyethylene sorbitan monoleate, stir evenly, and are standby; Aqueous solution after distillation collection is in addition collected, and medicinal residues decoct with water 1 hour, filters, filtrate and above-mentioned aqueous solution merge, and being concentrated into relative density is the clear paste of 1.05 (65 ℃), add ethanol and make and contain the alcohol amount and reach 73%, cold preservation below 4 ℃ filtered after 24 hours, reclaimed ethanol, and it is an amount of that concentrated solution adds water, cold preservation is spent the night below 0～4 ℃, filters, and filtrate and above-mentioned volatile oil, distillate merge, add ethylparaben, Mentholum, add water to ormal weight, regulate pH value to 5.0, mixing, promptly.
Function cures mainly: dispelling wind to relieve the exterior syndrome, heat clearing away is sensible.The nasal obstruction, the watery nasal discharge that are used to catch a cold and cause.
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.The spray manufacturing cost is higher, uses also not easily, simultaneously also can only can not play the effect for the treatment of both the principal and secondary aspects of a disease as topical administration.
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 deficiency of the oral drug preparation of treatment for diseases such as the existing nasal obstruction that causes of being used to catch a cold, watery nasal discharge, a kind of bioavailability height is provided, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and can play the Shangfengjing drop pill for the treatment of both the principal and secondary aspects of a disease effect.Shangfengjing drop pill involved in the present invention is a raw material with the extract that contains 4 flavor active ingredient of Chinese herbs such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain Shangfengjing drop pill involved in the present invention:
[preparation method]
1. raw material: the extract that contains 4 flavor active ingredient of Chinese herbs such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and 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, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix: a kind of preparation method of extract that contains 4 flavor active ingredient of Chinese herbs such as Flos Magnoliae]
Get Flos Magnoliae 100g, Flos Chrysanthemi Indici 100g, Herba Centipedae 75g, Mentholum 0.06g, above four Chinese medicine, except that Mentholum, three flavors such as all the other Flos Magnoliaes extract volatile oil with steam distillation, and are standby; Aqueous solution after distillation device is in addition collected, medicinal residues decoct with water 1 hour, filter, and filtrate and above-mentioned aqueous solution merge, be concentrated into relative density and be 1.05 clear paste, adding ethanol makes the alcohol amount of containing reach cold preservation below 73%, 4 ℃ to filter recovery ethanol after 24 hours, concentrated solution and above-mentioned distillate merge, be condensed into relative density and be 1.3～1.35 thick paste, add volatile oil, Mentholum, stir; Or be decompressed under 0.1MPa, 60 ℃ of conditions and make drying, be ground into dry powder promptly.
[beneficial effect]
The Shangfengjing spray that is prepared from according to the preparation method that provides among the national drug standards WS-11194 (ZD-1194)-2002, it is a kind of dispelling wind to relieve the exterior syndrome that has, the sensible effect of heat clearing away, the oral cavity external preparation of treatment for diseases such as the nasal obstruction that causes, watery nasal discharge is used to catch a cold, 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.The spray manufacturing cost is higher, uses also not easily, simultaneously also can only can not play the effect for the treatment of both the principal and secondary aspects of a disease as topical administration.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.
Shangfengjing drop pill involved in the present invention is compared with the Shangfengjing spray has following beneficial effect:
1. Shangfengjing drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum; 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. Shangfengjing drop pill involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. Shangfengjing drop pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of Shangfengjing drop pill of the present invention.
[first group: the test of single-matrix]
1. raw material: it is standby to make the extract dry powder that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum earlier according to [appendix];
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 obtain the Shangfengjing drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared Shangfengjing 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared Shangfengjing 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared Shangfengjing 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 16 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 16 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: it is standby to make the extract dry powder that contains 4 flavor Chinese medicine active pharmaceutical ingredients such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum earlier according to [appendix];
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 Shangfengjing 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 | ????64 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????83 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ????50.0 | ????84 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 10000 | ????50.0 | ????84 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????84 | ????＜30 | ????＞10 | ++ |
| Span 40 | ????50.0 | ????63 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????50.0 | ????71 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????64 | ????＞30 | ????＞10 | ++ |
| Sodium stearate | ????50.0 | ????64 | ????＞30 | ????＞10 | ++ |
| Glycerin gelatine | ????50.0 | ????63 | ????＞30 | ????＞10 | + |
| Lac | ????50.0 | ????63 | ????＞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 | ????75 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????25.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????25.0 | ????75 | ????＜30 | ????＞10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????78 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????73 | ????＞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 | ????83 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????89 | ????＜30 | ????＜10 | +++ |
| Span 40 | ????10.0 | ????74 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????87 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????73 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????74 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????72 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????70 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????70 | ????＞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 | ????83 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????83 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????80 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????76 | ????＜30 | ????＞10 | + |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜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 | ????89 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????89 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????86 | ????＜30 | ????＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????83 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????50 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????88 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????87 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????87 | ????＜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 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????89 | ????＜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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????86 | ????＜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 | ????89 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (6)
1. a pharmaceutical composition Shangfengjing drop pill that is used for the treatment of flu is a raw material with the extract that contains 4 flavor active ingredient of Chinese herbs such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum, 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. Shangfengjing drop pill as claimed in claim 1, it is characterized in that the described extract that contains 4 flavor active ingredient of Chinese herbs such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum is made by following method: get Flos Magnoliae 100g, Flos Chrysanthemi Indici 100g, Herba Centipedae 75g, Mentholum 0.06g, above four Chinese medicine, except that Mentholum, three flavors such as all the other Flos Magnoliaes extract volatile oil with steam distillation, and are standby; Aqueous solution after distillation device is in addition collected, medicinal residues decoct with water 1 hour, filter, and filtrate and above-mentioned aqueous solution merge, be concentrated into relative density and be 1.05 clear paste, adding ethanol makes the alcohol amount of containing reach cold preservation below 73%, 4 ℃ to filter recovery ethanol after 24 hours, concentrated solution and above-mentioned distillate merge, be condensed into relative density and be 1.3～1.35 thick paste, add volatile oil, Mentholum, stir; Or be decompressed under 0.1MPa, 60 ℃ of conditions and make drying, be ground into dry powder promptly.
3. Shangfengjing drop pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
4. as claim 1 or 3 described any Shangfengjing drop pill, it is characterized in that: describedly contain the extract of Flos Lonicerae, Folium mangiferae, Herba Taraxaci, Radix Platycodonis, the Radix Stemonae, Pericarpium Citri Reticulatae, Radix Glycyrrhizae etc. 7 flavor active ingredient of Chinese herbs and the mixed proportion of substrate is 1: 1～1: 5.
5. the preparation method of a red Shangfengjing drop pill is characterized in that being made of following process:
5.1 raw material: the extract that contains 4 flavor active ingredient of Chinese herbs such as Flos Magnoliae, Flos Chrysanthemi Indici, Herba Centipedae, Mentholum;
5.2 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;
5.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
5.4, 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 Radix Astragali extract and substrate and/or emulsion and/or suspension;
5.5 adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on 40 ℃～-5 ℃;
5.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent and shrink molding promptly.
6. as the preparation method of Shangfengjing drop pill as described in the claim 4, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| CN105250385A (en) * | 2015-11-16 | 2016-01-20 | 青岛麦瑞特医药技术有限公司 | Nasal drops for treating infant nasal obstruction |
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| CN105250385A (en) * | 2015-11-16 | 2016-01-20 | 青岛麦瑞特医药技术有限公司 | Nasal drops for treating infant nasal obstruction |
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