CN1292738C - Ginseng-pilose antler dripping pill for tonifying heart and kidney and its preparing method - Google Patents
Ginseng-pilose antler dripping pill for tonifying heart and kidney and its preparing method Download PDFInfo
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- CN1292738C CN1292738C CNB200510008904XA CN200510008904A CN1292738C CN 1292738 C CN1292738 C CN 1292738C CN B200510008904X A CNB200510008904X A CN B200510008904XA CN 200510008904 A CN200510008904 A CN 200510008904A CN 1292738 C CN1292738 C CN 1292738C
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Abstract
The present invention relates to a medicine composition used for the treatment of body weakness, spirit timidity, heart palpitation, breath shortness, lassitude in the waist and leg, impotence, emission and other disorders, which has the functions of heart-energy supplement and the invigoration of the heart and kidney. The present invention has the purposes for complementing the deficiency of the existing oral medicine preparations used for the treatment of the disorders and providing a ginseng-antler dripping pill which is an oral medical composition preparation having high bioavailability, quick medicine release, rapid effect, high medicine content, accurate administration measurement, low price and convenient carrying. The ginseng-antler dripping pill of the present invention is prepared from the raw materials of ginseng, antler and other Chinese medicines, and a medicinal carrier serving as a matrix.
Description
Technical field
The present invention relates to a kind of reinforcing the heart gas that has, the effect of benefit heart kidney, it is empty refreshing timid to be used for body, shortness of breath and palpitation, soreness of the waist and knees, the pharmaceutical composition of treatment for diseases such as impotence and seminal emission is a kind of drug composition oral preparation that feedstock production forms with the extract that contains 2 flavor Chinese medicine active pharmaceutical ingredients such as Radix Ginseng, Cornu Cervi Pantotrichum particularly.
Background technology
The ginseng and pilose antler oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-11509 (ZD-1509)-2002, be a kind of reinforcing the heart gas that has, the effect of benefit heart kidney, it is empty refreshing timid to be used for body, shortness of breath and palpitation, soreness of the waist and knees, the syrups oral formulations of treatment for diseases such as impotence and seminal emission, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Below be prescription and technology and the brief description that provides in WS-11509 (ZD-1509)-2002 drug standard:
Prescription: Radix Ginseng 40g, Cornu Cervi Pantotrichum 7g, Mel 300g, Ovum Gallus domesticus album 20ml, sodium benzoate 2g, essence (Fructus Citri tangerinae type) 10ml
Method for making: above two flavor medical materials, Radix Ginseng (going reed) is ground into coarse powder, under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia version in 2000), make solvent with 40% ethanol, flood and carry out percolation after 5 days, collect the liquid of filtering, medicinal residues reuse 30% ethanol is handled by last method, merges the liquid of filtering twice, reclaims ethanol, the cold back of medicinal liquid adds Ovum Gallus domesticus album and stirs evenly, in 70～80 ℃ of heating 30 minutes, cold preservation 24 hours, filter, the filtrate thin up is to 400ml, cold preservation 48 hours, filter is to clarification, filtrate for later use; Other gets the Cornu Cervi Pantotrichum chopping, adds Diluted Alcohol, reflux, extract, four times, and each 4 hours, merge extractive liquid, reclaimed ethanol, is concentrated into every 1ml and is equivalent to Cornu Cervi Pantotrichum 1g, added 5 times of amount 30% ethanol, was diluted to every 1ml with suitable quantity of water and was equivalent to Cornu Cervi Pantotrichum 0.1g, filtered filtrate for later use.Other gets Mel 300g heated and boiled, filters while hot, adds above-mentioned Radix Ginseng, and Cornu Cervi Pantotrichum filtrate stirs evenly, and boils 15 minutes, when waiting to be chilled to 40 ℃, adds sodium benzoate and essence, adds water to ormal weight after being chilled to room temperature, stirs evenly, and leaves standstill, filter, and fill, sterilization, promptly.
Function cures mainly: reinforcing the heart gas, beneficial heart kidney.It is empty refreshing timid to be used for body, shortness of breath and palpitation, soreness of the waist and knees, impotence and seminal emission.
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.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish that existing to be used for body empty refreshing timid, shortness of breath and palpitation, soreness of the waist and knees, the deficiency of the oral drug preparation of treatment for diseases such as impotence and seminal emission, a kind of bioavailability height is provided, and has quick release, fast produce effects, the medicament contg height, take accurate measurement, cheap, and portable drug composition oral preparation ginseng-pilose antler dripping pill.
Ginseng-pilose antler dripping pill involved in the present invention is a raw material with 2 flavor Chinese medicines such as Radix Ginseng, Cornu Cervi Pantotrichum, after extraction obtains containing the extract of above two flavor Chinese medicine active pharmaceutical ingredients, is prepared from the pharmaceutically suitable carrier as substrate again.Be prepared by the following technical solutions, can obtain ginseng-pilose antler dripping pill involved in the present invention:
[preparation method]
1. raw material: through extraction and the extract thick paste or the dry powder that contain 2 flavor active ingredient of Chinese herbs such as Radix Ginseng, Cornu Cervi Pantotrichum;
2. substrate: Polyethylene Glycol
(2000～20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[appendix: a kind of drug extract preparation method that contains Radix Ginseng, pilose antler active composition] is unit with g or kg, according to the weight portion meter, get 40 parts of Radix Ginsengs, 7 parts in Cornu Cervi Pantotrichum, more than two the flavor medical materials, Radix Ginseng goes reed, is ground into coarse powder, under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and extractum item, make solvent with 40% ethanol, flood and carry out percolation after 5 days, collect the liquid of filtering, medicinal residues reuse 30% ethanol is handled by last method, merge the liquid of filtering twice, reclaim ethanol, filter filtrate for later use; Other gets the Cornu Cervi Pantotrichum chopping, adds Diluted Alcohol, reflux, extract, 4 times, each 4 hours, merge extractive liquid, reclaimed ethanol, be concentrated into every 1ml and be equivalent to Cornu Cervi Pantotrichum 1g, add 5 times of amount 30% ethanol, be diluted to every 1ml with suitable quantity of water and be equivalent to Cornu Cervi Pantotrichum 0.1g, filter, filtrate and preceding Radix Ginseng filtrate merge, under decompression (0.1MPa), low temperature (60 ℃) condition, be condensed into relative density and be 1.3～1.35 thick paste, or under similarity condition, continue to make drying, be ground into dry powder promptly.
What provide above is a kind of preparation method of common drug extract, under the same or analogous prerequisite of main active pharmaceutical ingredient of extract, is not limited to this a kind of method.
Beneficial effect
The ginseng and pilose antler oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-11509 (ZD-1509)-2002, be a kind of reinforcing the heart gas that has, the effect of benefit heart kidney, it is empty refreshing timid to be used for body, shortness of breath and palpitation, soreness of the waist and knees, the syrups oral formulations of treatment for diseases such as impotence and seminal emission, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.And the syrups oral formulations also exist medicament contg low, take metering and be difficult to accurately, take or carry shortcomings such as inconvenience.
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.
Ginseng-pilose antler dripping pill involved in the present invention is compared with the ginseng and pilose antler oral liquid has following beneficial effect:
1. ginseng-pilose antler dripping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains two flavor active ingredient of Chinese herbs such as Radix Ginseng, Cornu Cervi Pantotrichum; 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. ginseng-pilose antler dripping 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. ginseng-pilose antler dripping 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 ginseng-pilose antler dripping pill of the present invention.
First group: the test of single-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains two flavor active ingredient of Chinese herbs such as Radix Ginseng, Cornu Cervi Pantotrichum earlier according to [appendix: a kind of drug extract preparation method that contains Radix Ginseng, pilose antler active composition];
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), one or more the mixture in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the ginseng-pilose antler dripping pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared ginseng-pilose antler dripping pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared ginseng-pilose antler dripping pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared ginseng-pilose antler dripping pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain 15 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. the preparation of drug extract: it is standby to make the extract dry powder that contains two flavor active ingredient of Chinese herbs such as Radix Ginseng, Cornu Cervi Pantotrichum earlier according to [appendix: a kind of drug extract preparation method that contains Radix Ginseng, pilose antler active composition];
2. substrate:
2.1 Polyethylene Glycol---English name Maerogol,
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 ginseng-pilose antler dripping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared ginseng-pilose antler dripping 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, 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 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 ginseng-pilose antler dripping 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, 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 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 ginseng-pilose antler dripping 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, 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 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 ginseng-pilose antler dripping 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, 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 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 ginseng-pilose antler dripping 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, 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 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 ginseng-pilose antler dripping 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, 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 experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained ginseng-pilose antler dripping pill when 1: 1 proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained ginseng-pilose antler dripping pill when 1: 3 proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained ginseng-pilose antler dripping pill when 1: 9 proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, adopt homemade drop pill machine, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different 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 2000 | 50.0 | 62 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 75 | ＜30 | ＞10 | + |
| Polyethylene Glycol 6000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 73 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 69 | ＜30 | ＞10 | + |
| Poloxamer | 50.0 | 75 | ＜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 | 55 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 57 | ＞30 | ＞10 | + |
| Lac | 50.0 | 56 | ＞30 | ＞10 | + |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 25.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 77 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 73 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 71 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 70 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 70 | ＞30 | ＞10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | 10.0 | 81 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 91 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 84 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 84 | ＜30 | ＞10 | +++ |
| Sodium lauryl sulphate | 10.0 | 78 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 73 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 72 | ＞30 | ＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 84 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 82 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 79 | ＜30 | ＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 72 | ＜30 | ＞10 | + |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 88 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 25 | 83 | ＜30 | ＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 10 | 88 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 89 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 83 | ＜30 | ＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 80 | ＜30 | ＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 89 | ＜30 | ＜10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 93 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 10 | 90 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 50 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 90 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 87 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 92 | ＜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 (2)
1. a ginseng-pilose antler dripping pill is a raw material with Radix Ginseng, Cornu Cervi Pantotrichum, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1), gets 40 parts of Radix Ginsengs, 7 parts in Cornu Cervi Pantotrichum according to the weight portion meter, more than two the flavor medical materials, Radix Ginseng goes reed, is ground into coarse powder, under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and extractum item, make solvent with 40% ethanol, flood and carry out percolation after 5 days, the collection liquid of filtering, medicinal residues reuse 30% ethanol is handled by last method, merges the liquid of filtering twice, reclaims ethanol, filter filtrate for later use; Other gets the Cornu Cervi Pantotrichum chopping, add Diluted Alcohol, reflux, extract, 4 times, each 4 hours, merge extractive liquid,, reclaim ethanol, be concentrated into every 1ml and be equivalent to Cornu Cervi Pantotrichum 1g, add 5 times of amount 30% ethanol, be diluted to every 1ml with suitable quantity of water and be equivalent to Cornu Cervi Pantotrichum 0.1g, filter, filtrate and the merging of preceding Radix Ginseng filtrate, to be condensed into relative density under 0.1MPa, the 60 ℃ of cryogenic conditions be 1.3～1.35 thick paste being decompressed to, or under similarity condition, continue to make drying, be ground into dry powder, promptly get the extract that contains Radix Ginseng and effective constituent of pilose antler, 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, describedly contains the extract of Radix Ginseng and effective constituent of pilose antler and the ratio of 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 drug 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 remains on 50 ℃～90 ℃, and the cooling of condensing agent also remains on 40 ℃～-5 ℃;
(5) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively when reaching described state of temperature, will contain fused solution and/or the emulsion and/or the suspension of drug extract and substrate, places in the water dropper jar of drop pill machine, splashes in the condensing agent and shrinks molding promptly.
2. ginseng-pilose antler dripping pill according to 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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| CN101491563B (en) * | 2008-12-19 | 2011-09-28 | 四川美大康药业股份有限公司 | Ginseng and pilose antler oral preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1436527A (en) * | 2002-02-07 | 2003-08-20 | 王志刚 | Glimepiride dripping pills |
| CN1546141A (en) * | 2003-12-12 | 2004-11-17 | 北京科信必成医药科技发展有限公司 | Blumea oil dripping pills and its preparation process |
| CN1546027A (en) * | 2003-12-02 | 2004-11-17 | 北京正大绿洲医药科技有限公司 | Dripping pills for treating allergic disease and its preparation process |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1436527A (en) * | 2002-02-07 | 2003-08-20 | 王志刚 | Glimepiride dripping pills |
| CN1546027A (en) * | 2003-12-02 | 2004-11-17 | 北京正大绿洲医药科技有限公司 | Dripping pills for treating allergic disease and its preparation process |
| CN1546141A (en) * | 2003-12-12 | 2004-11-17 | 北京科信必成医药科技发展有限公司 | Blumea oil dripping pills and its preparation process |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101491563B (en) * | 2008-12-19 | 2011-09-28 | 四川美大康药业股份有限公司 | Ginseng and pilose antler oral preparation and preparation method thereof |
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