CN100542515C - Milkwort root pill and preparation method thereof - Google Patents
Milkwort root pill and preparation method thereof Download PDFInfo
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- CN100542515C CN100542515C CNB200510002878XA CN200510002878A CN100542515C CN 100542515 C CN100542515 C CN 100542515C CN B200510002878X A CNB200510002878X A CN B200510002878XA CN 200510002878 A CN200510002878 A CN 200510002878A CN 100542515 C CN100542515 C CN 100542515C
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- 206010036790 Productive cough Diseases 0.000 claims abstract description 8
- 239000002202 Polyethylene glycol Substances 0.000 claims description 95
- 229920001223 polyethylene glycol Polymers 0.000 claims description 95
- 239000000284 extract Substances 0.000 claims description 79
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- 239000002552 dosage form Substances 0.000 abstract description 4
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- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 description 28
- 235000011175 beta-cyclodextrine Nutrition 0.000 description 28
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- 238000000034 method Methods 0.000 description 22
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 16
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- 238000005516 engineering process Methods 0.000 description 9
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 9
- 239000001828 Gelatine Substances 0.000 description 8
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 8
- 239000004141 Sodium laurylsulphate Substances 0.000 description 8
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- 229920000159 gelatin Polymers 0.000 description 8
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- 235000019333 sodium laurylsulphate Nutrition 0.000 description 8
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 8
- 239000008117 stearic acid Substances 0.000 description 8
- 239000004353 Polyethylene glycol 8000 Substances 0.000 description 6
- 235000020357 syrup Nutrition 0.000 description 6
- 239000006188 syrup Substances 0.000 description 6
- 235000015424 sodium Nutrition 0.000 description 5
- 239000000428 dust Substances 0.000 description 4
- 230000036541 health Effects 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 3
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- 239000000470 constituent Substances 0.000 description 2
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- 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
- 206010011224 Cough Diseases 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
- 206010070840 Gastrointestinal tract irritation Diseases 0.000 description 1
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- 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
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- 229920000573 polyethylene Polymers 0.000 description 1
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- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 1
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Abstract
The present invention relates to a kind of not well pharmaceutical composition that waits symptom treatment of expectoration that is used for,, change a social system a kind of drug composition oral dropping pill formulation that forms through dosage form particularly based on the Chinese traditional patent formulation syrupus polygalae.Purpose of the present invention is that replenishing existing is a kind of expectorant; Be used for the not well deficiency that waits the oral drug preparation of symptom treatment of expectoration, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and medicament contg height, taking dose is little, and taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation milkwort root pill of going out to carry.Milkwort root pill involved in the present invention is that the basis is prepared from the extraction process of Chinese traditional patent formulation syrupus polygalae.
Description
Technical field
The present invention relates to a kind of not well pharmaceutical composition that waits symptom treatment of expectoration that is used for,, change a social system a kind of drug composition oral dropping pill formulation that forms through dosage form particularly based on the Chinese traditional patent formulation syrupus polygalae.
Background technology
According to national drug standards WS
3The syrupus polygalae that prescription that provides among-the B-2140-96 and extraction process are prepared from is a kind of expectorant.Be used for the not well syrups preparation that waits symptom treatment of expectoration, through clinical verification for many years, steady quality, determined curative effect is clinical and family is used for the treatment of the common drug preparation of above disease.
Below be drug standard WS
3The prescription of the syrupus polygalae that provides among-the B-2140-96 and extraction process:
Prescription: Radix Polygalae fluid extractum 200ml, liquor ammoniae fortis 4ml;
Method for making: get Radix Polygalae fluid extractum, add water 50ml, mixing adds liquor ammoniae fortis, and mixing leaves standstill, and filters, and filtrate adds simple syrup makes into 1000ml, mixing, promptly.
Be explained as follows for this syrup in the appended syrupus polygalae description:
Nomenclature of drug: syrupus polygalae;
Main component: Radix Polygalae fluid extractum;
The effect classification: this product is cough class nonprescription drugs medicine.
Function cures mainly: expectorant.It is not well to be used for expectoration.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.It is low that the syrups medicine also exists medicament contg, takes metering and be difficult to accurately take, carry shortcomings such as inconvenience.In addition, conventional peroral dosage form as syrup, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention is that replenishing existing is a kind of expectorant; Be used for the not well deficiency that waits the oral drug preparation of symptom treatment of expectoration, a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is littler, and medicament contg height, taking dose is little, and taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation milkwort root pill of going out to carry.Milkwort root pill involved in the present invention determines that through a large amount of experiment sievings based on the extraction process of Chinese traditional patent formulation syrupus polygalae, process is adjusted extracting section technology, and cooperates drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain milkwort root pill involved in the present invention:
[preparation method]
1. Radix Polygalae fluid extractum obtains thick paste through concentrating, or drying pulverizes that to obtain dry powder standby again;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as Polyethylene Glycol (1000～20000), 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. treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step and is incubated during desired state of temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, condensing agent can be any one of liquid paraffin, methyl-silicone oil, 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 Radix Polygalae extract]
Get powder in the Radix Polygalae, (appendix IO of 2000 editions Pharmacopoeias of People's Republic of China) makes solvent with 60% ethanol according to the percolation under fluid extract and the extractum item, flood after 24 hours, with the speed of per minute 1～3ml percolation slowly, collect the liquid 850ml that just filters, device is preserved in addition, continue percolation, the effective ingredient of waiting is filtered out fully, collects the continuous liquid of filtering, and is being concentrated into the thick paste shape below 60 ℃, add filtrate just, mix back dropping liquor ammoniae fortis and make little apparent alkalescence in right amount, and have ammonia smelly, add 60% ethanol dilution again and make into 1000ml, leave standstill, the clarification of waiting filters, and promptly gets Radix Polygalae fluid extractum; Directly pass through low temperature, drying under reduced pressure again with Radix Polygalae fluid extractum, pulverize, promptly get dry powder.Perhaps get Radix Polygalae fluid extractum 200mL, add water 50mL, mixing adds liquor ammoniae fortis 4mL, and mixing leaves standstill, and filters, and gets filtrate extractum; Or pass through low temperature, drying under reduced pressure again, and pulverize, promptly get dry powder.
Given here is according to drug standard WS
3A kind of preparation method of extract change among the-B-2140-96 forms, and similarly method is a lot, is not limited to this a kind of method during actual enforcement.
Beneficial effect
According to national drug standards WS
3The syrupus polygalae that prescription that provides among-the B-2140-96 and extraction process are prepared from is a kind of expectorant; Be used for the not well syrups preparation that waits symptom treatment of expectoration, through clinical verification for many years, steady quality, determined curative effect is clinical and family is used for the treatment of the common drug preparation of above disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society; And contain very high sugared composition in the syrup, others takes to be unfavorable for diabetes more; And tincture contains a large amount of ethanol, and suitable crowd is also limited; Fluid extract directly take be not only carry still preserve all very inconvenient.
Milkwort root pill involved in the present invention is compared with syrupus polygalae, has following beneficial effect:
1. milkwort root pill involved in the present invention; utilize surfactant etc. to be substrate; make solid dispersion with extractum that contains active constituents of medicine or dry powder; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases, and substrate is hydrophilic, and medicine is had wetting action; can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with the administering mode of traditional oral formulations, exist essential distinction.With the drop pill of solid dispersion technology preparation, can adopt oral, can also sublingual administration, effective ingredient is fully contacted with mucomembranous surface, by the mucomembranous epithelial cell absorption, directly enter blood circulation.Owing to directly enter blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to have an onset, bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. milkwort root pill involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum, and local application's onset is faster.
3. milkwort root 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.
In sum, make milkwort root pill involved in the present invention have the advantage of triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of milkwort root pill of the present invention:
First group: the test of single-matrix
1. it is standby to make the extract dry powder of Radix Polygalae according to [appendix: a kind of preparation method of Radix Polygalae extract];
2. substrate: Polyethylene Glycol
(1000～20000), pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1:1～1:9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the milkwort root pill of various different sizes.
[result of the test]
Test 1: for observe drug extract and different substrates when the proportioning of 1:1 prepared milkwort root pill in qualitative difference, according to the ratio of 1:1, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when the proportioning of 1:3 prepared milkwort root pill in qualitative difference, according to the ratio of 1:3, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when the proportioning of 1:9 prepared milkwort root pill in qualitative difference, according to the ratio of 1:9, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. it is standby to make the extract dry powder of Radix Polygalae according to [appendix: a kind of preparation method of Radix Polygalae extract];
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. (with g or kg is unit to proportioning, by weight)
3.1 the ratio of composite interstitial substance---polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1:1～1:10,
3.2 hybrid medicine extract: mixed-matrix weight and=1:1～1:9;
4. be prepared according to the process of [preparation method] 4～7 again, promptly can make the milkwort root pill of various different sizes.
[result of the test]
Test 4: for observe drug extract and mixed-matrix when the proportioning of 1:1 prepared milkwort root pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:1 evenly as mixed-matrix, according to the ratio of 1:1 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe drug extract and mixed-matrix when the proportioning of 1:3 prepared milkwort root pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:1 evenly as mixed-matrix, according to the ratio of 1:3 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe drug extract and mixed-matrix when the proportioning of 1:9 prepared milkwort root pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:1 evenly as mixed-matrix, according to the ratio of 1:9 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe drug extract and mixed-matrix when the proportioning of 1:1 prepared milkwort root pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:5 evenly as mixed-matrix, according to the ratio of 1:1 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe drug extract and mixed-matrix when the proportioning of 1:3 prepared milkwort root pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:5 evenly as mixed-matrix, according to the ratio of 1:3 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe drug extract and mixed-matrix when the proportioning of 1:9 prepared milkwort root pill in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:5 evenly as mixed-matrix, according to the ratio of 1:9 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe milkwort root pill that drug extract and mixed-matrix make when the proportioning of 1:1 in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:10 evenly as mixed-matrix, according to the ratio of 1:1 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe milkwort root pill that drug extract and mixed-matrix make when the proportioning of 1:3 in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:10 evenly as mixed-matrix, according to the ratio of 1:3 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe milkwort root pill that drug extract and mixed-matrix make when the proportioning of 1:9 in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with the mixed of 1:10 evenly as mixed-matrix, according to the ratio of 1:9 drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 drug extract and single-matrix
(drug extract: substrate=1:1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 80 | <30 | >10 | + |
| Polyethylene Glycol 2000 | 50.0 | 80 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 50.0 | 88 | <30 | >10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 82 | <30 | >10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 79 | <30 | >10 | ++ |
| Polyethylene Glycol 9300 | 50.0 | 88 | <30 | >10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | <30 | >10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 80 | <30 | >10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | <30 | >10 | ++ |
| Betacyclodextrin | 50.0 | 72 | <30 | >10 | + |
| Poloxamer | 50.0 | 79 | <30 | >10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | <30 | >10 | + |
| Sodium lauryl sulphate | 50.0 | 68 | >30 | >10 | ++ |
| Stearic acid | 50.0 | 55 | >30 | >10 | +++ |
| Sodium stearate | 50.0 | 54 | >30 | >10 | +++ |
| Glycerin gelatine | 50.0 | 55 | >30 | >10 | +++ |
| Lac | 50.0 | 52 | >30 | >10 | +++ |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1:3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 25.0 | 80 | <30 | >10 | + |
| Polyethylene Glycol 2000 | 25.0 | 88 | <30 | >10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 86 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 93 | <30 | <10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 93 | <30 | <10 | +++ |
| Polyethylene Glycol 9300 | 25.0 | 94 | <30 | >10 | ++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | <30 | <10 | ++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 92 | <30 | <10 | ++ |
| Betacyclodextrin | 25.0 | 82 | <30 | >10 | ++ |
| Poloxamer | 25.0 | 89 | <30 | <10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 80 | <30 | >10 | ++ |
| Sodium lauryl sulphate | 25.0 | 77 | <30 | >10 | ++ |
| Stearic acid | 25.0 | 73 | >30 | >10 | +++ |
| Sodium stearate | 25.0 | 72 | >30 | >10 | +++ |
| Glycerin gelatine | 25.0 | 71 | >30 | >10 | +++ |
| Lac | 25.0 | 72 | >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 | 80 | <30 | >10 | + |
| Polyethylene Glycol 2000 | 10.0 | 83 | <30 | >10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 93 | <30 | <10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 94 | <30 | <10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 92 | <30 | <10 | +++ |
| Polyethylene Glycol 9300 | 10.0 | 89 | <30 | >10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 93 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | <30 | <10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 93 | <30 | <10 | ++ |
| Betacyclodextrin | 10.0 | 88 | <30 | <10 | ++ |
| Poloxamer | 10.0 | 92 | <30 | <10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 86 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 10.0 | 83 | <30 | >10 | +++ |
| Stearic acid | 10.0 | 76 | >30 | >10 | +++ |
| Sodium stearate | 10.0 | 77 | >30 | >10 | +++ |
| Glycerin gelatine | 10.0 | 74 | >30 | >10 | +++ |
| Lac | 10.0 | 73 | >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 | 86 | <30 | <10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:1 | 50 | 81 | <30 | >10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1:1 | 50 | 78 | <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 | 92 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:1 | 25 | 93 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:1 | 25 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:1 | 25 | 86 | <30 | >10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1:9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1:1 | 10 | 92 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:1 | 10 | 92 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:1 | 10 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:1 | 10 | 84 | <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 | 94 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:5 | 50 | 94 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:5 | 50 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:5 | 50 | 83 | <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 | 94 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:5 | 25 | 95 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:5 | 25 | 92 | <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 | 95 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:5 | 10 | 94 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:5 | 10 | 91 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:5 | 10 | 88 | <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 | 82 | <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 | 94 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:10 | 25 | 93 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:10 | 25 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:10 | 25 | 87 | <30 | <10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1:9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1:10 | 10 | 94 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:10 | 10 | 93 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:10 | 10 | 91 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:10 | 10 | 90 | <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 comparatively desirable, 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, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. a milkwort root pill that is used for treatment for diseases such as expectoration is not well is a raw material with the Radix Polygalae, is prepared from a certain proportion of pharmaceutically suitable carrier, it is characterized in that:
(1) get powder in the Radix Polygalae, according to the percolation under fluid extract and the extractum item, this percolation is according to appendix IO of 2000 editions Pharmacopoeias of People's Republic of China; Make solvent with 60% ethanol, flood after 24 hours, with the speed of per minute 1～3ml percolation slowly, collect the liquid 850ml that just filters, device is preserved in addition, continues percolation, the effective ingredient of waiting is filtered out fully, collects the continuous liquid of filtering, and is being concentrated into the thick paste shape below 60 ℃, add filtrate just, mix back dropping liquor ammoniae fortis and make little apparent alkalescence in right amount, and have ammonia smelly, add 60% ethanol dilution again and make into 1000ml, leave standstill, the clarification of waiting, filter, promptly get Radix Polygalae fluid extractum; Directly pass through low temperature, drying under reduced pressure again with Radix Polygalae fluid extractum, pulverize, promptly get dry powder.Perhaps get Radix Polygalae fluid extractum 200mL, add water 50mL, mixing adds liquor ammoniae fortis 4mL, and mixing leaves standstill, and filters, and gets filtrate extractum; Or pass through low temperature, drying under reduced pressure again, and pulverize, promptly get the extract that contains the Radix Polygalae effective ingredient, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium, by weight, the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, and the ratio of described extract and substrate is 1: 3;
(3) according to aforementioned proportion, accurately take by weighing described extract and substrate, be placed in the heating container heating while stirring, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at-5 ℃～40 ℃;
When (5) treating that dropping-pill machine head and condensing agent are stable respectively and reach described state of temperature, insulation places in the water dropper jar of drop pill machine, splashes into to shrink in the condensing agent by water dropper to be shaped promptly.
2. milkwort root pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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