CN1315460C - Velvet deerhorn drip pill and its preparation method - Google Patents
Velvet deerhorn drip pill and its preparation method Download PDFInfo
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- CN1315460C CN1315460C CNB2005100556189A CN200510055618A CN1315460C CN 1315460 C CN1315460 C CN 1315460C CN B2005100556189 A CNB2005100556189 A CN B2005100556189A CN 200510055618 A CN200510055618 A CN 200510055618A CN 1315460 C CN1315460 C CN 1315460C
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Abstract
The present invention relates to a medicine composition used for the treatment of impotence, spermatorrhoea, gastric cold, weakness, blood deficiency, circumgyration, waist weakness, leg adynamia, asthenia cold metrorrhagia and other disorders, particularly an oral medicine composition preparation prepared from the raw material of antler. The present invention has the purpose of complementing the deficiency of existing oral medicine preparations used for the treatment of the disorders, providing antler dripping pills having high bioavailability, quick medicine release, rapid effect, high medicine content, accurate administration measurement, low price and convenient carrying. The antler dripping pills of the present invention are prepared from an extract containing the active medicinal components of antler as a raw material and medicinal carriers serving as matrixes.
Description
Technical field
The present invention relates to a kind of warming the kidney to invigorate YANG that has, spermatogenesis nourishes blood, and mends the strong bone effect of marrow, be used for the sexual impotence spermatorrhea, cold syndrome of the stomach is unable, dizziness due to deficiency of blood, waist knee joint flaccidity is soft, and the pharmaceutical composition of treatment for diseases such as asthenia cold metrorrhagia particularly is a kind of drug composition oral preparation that feedstock production forms with the Cornu Cervi Pantotrichum.
Background technology
The pantocrin oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-11405 (ZD-1405)-2002, be a kind of warming the kidney to invigorate YANG that has, spermatogenesis nourishes blood, and mends the strong bone effect of marrow, be used for the sexual impotence spermatorrhea, cold syndrome of the stomach is unable, dizziness due to deficiency of blood, and waist knee joint flaccidity is soft, the syrups oral formulations of treatment for diseases such as asthenia cold metrorrhagia, 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 in WS-11405 (ZD-1405)-2002 drug standard:
Prescription: Cornu Cervi Pantotrichum (unhairing) 10g, sodium citrate 10g, Fructus Citri tangerinae essence 2ml, Mel 700g
Method for making: get Cornu Cervi Pantotrichum, add the Diluted Alcohol reflux, extract, five times, each 2 hours, merge extractive liquid,, reclaim ethanol and also be concentrated into the clear paste that relative density is 1.20～1.25 (20 ℃), under agitation add ethanol and make and contain the alcohol amount and reach 80%, left standstill 24 hours, get supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.20～1.25 (20 ℃), thin up becomes to contain the solution of crude drug 60%, and cold preservation was left standstill 16 hours, filter filtrate for later use.Other gets Mel, and is warm, gets sodium citrate and adds water and make dissolving in right amount, adds in the Mel, stir evenly, be heated to 100 ℃, kept 20 minutes, filter while hot, filtrate adds above-mentioned Cornu Cervi Pantotrichum concentrated solution, stirs evenly, wait to be chilled to below 60 ℃, add Fructus Citri tangerinae essence, add water to ormal weight, stir evenly, filter, regulate pH value to 4.5～6.5, fill, sterilization, promptly.
Function cures mainly: warming the kidney to invigorate YANG, spermatogenesis nourishes blood, and mends the strong bone of marrow.Be used for the sexual impotence spermatorrhea, cold syndrome of the stomach is unable, dizziness due to deficiency of blood, and waist knee joint flaccidity is soft, asthenia cold metrorrhagia.
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 is that additional having now is used for the sexual impotence spermatorrhea, and cold syndrome of the stomach is unable, dizziness due to deficiency of blood, waist knee joint flaccidity is soft, and the deficiency of the oral drug preparation of treatment for diseases such as asthenia cold metrorrhagia provides a kind of bioavailability height, and has a quick release, quick produce effects, the medicament contg height is taken accurate measurement, cheap, and portable velvet deerhorn drip pill.
Velvet deerhorn drip pill involved in the present invention is a raw material with the extract that contains the pilose antler active ingredient, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain velvet deerhorn drip pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: with g or kg is unit, and it is an amount of to get Cornu Cervi Pantotrichum, adds the Diluted Alcohol reflux, extract, five times, each 2 hours, and merge extractive liquid,, reclaiming ethanol and being concentrated into relative density is 1.3～1.35 thick paste, or continues to make drying, is 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;
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, 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.
[beneficial effect]
The pantocrin oral liquid that is prepared from according to the preparation method that provides among the national drug standards WS-11405 (ZD-1405)-2002, be a kind of warming the kidney to invigorate YANG that has, spermatogenesis nourishes blood, and mends the strong bone effect of marrow, be used for the sexual impotence spermatorrhea, cold syndrome of the stomach is unable, dizziness due to deficiency of blood, and waist knee joint flaccidity is soft, the syrups oral formulations of treatment for diseases such as asthenia cold metrorrhagia, 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.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.
Velvet deerhorn drip pill involved in the present invention is compared with pantocrin oral liquid has following beneficial effect:
1. velvet deerhorn drip pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains the pilose antler active ingredient, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; 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.
2. velvet deerhorn drip 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. velvet deerhorn drip 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 velvet deerhorn drip 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 the pilose antler active ingredient earlier according to [preparation method 1];
2. substrate: cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, cetomacrogol 1000 0, Macrogol 2000 0, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, span 40, Tween 80, 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 velvet deerhorn drip pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared velvet deerhorn drip pill in qualitative difference, ratio according to 1: 1, with drug extract respectively with cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, cetomacrogol 1000 0, Macrogol 2000 0, span 40, Tween 80, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, pharmaceutically suitable carrier such as Lac match, 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 velvet deerhorn drip pill in qualitative difference, ratio according to 1: 3, with drug extract respectively with cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, cetomacrogol 1000 0, Macrogol 2000 0, span 40, Tween 80, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, pharmaceutically suitable carrier such as Lac match, 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 velvet deerhorn drip pill in qualitative difference, ratio according to 1: 9, with drug extract respectively with cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, cetomacrogol 1000 0, Macrogol 2000 0, span 40, Tween 80, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, pharmaceutically suitable carrier such as Lac match, 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 16 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 the pilose antler active ingredient earlier according to [preparation method 1];
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 velvet deerhorn drip pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared velvet deerhorn drip 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 velvet deerhorn drip 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 velvet deerhorn drip 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 velvet deerhorn drip 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 velvet deerhorn drip 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 velvet deerhorn drip 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, department obtains 4 pharmaceutical compositions that drug extract and mixed-matrix constituted and tests, and obtains 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 velvet deerhorn drip 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 velvet deerhorn drip 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 velvet deerhorn drip 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 |
| Cetomacrogol 1000 | 50.0 | 61 | ＜30 | ＞10 | + |
| Macrogol 4000 | 50.0 | 85 | ＜30 | ＞10 | + |
| Polyethylene glycol 6000 | 50.0 | 88 | ＜30 | ＜10 | + |
| Cetomacrogol 1000 0 | 50.0 | 89 | ＜30 | ＜10 | ++ |
| Macrogol 2000 0 | 50.0 | 89 | ＜30 | ＜10 | ++ |
| Span 40 | 50.0 | 62 | ＜30 | ＞10 | + |
| Tween 80 | 50.0 | 60 | ＞30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 85 | ＜30 | ＞10 | ++ |
| Betacyclodextrin | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 87 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | ＜30 | ＞10 | + |
| Sodium lauryl sulphate | 50.0 | 73 | ＜30 | ＞10 | ++ |
| Stearic acid | 50.0 | 63 | ＞30 | ＞10 | ++ |
| Sodium stearate | 50.0 | 62 | ＞30 | ＞10 | ++ |
| Glycerin gelatine | 50.0 | 59 | ＞30 | ＞10 | + |
| Lac | 50.0 | 57 | ＞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 |
| Cetomacrogol 1000 | 25.0 | 78 | ＜30 | ＞10 | ++ |
| Macrogol 4000 | 25.0 | 92 | ＜30 | ＜10 | ++ |
| Polyethylene glycol 6000 | 25.0 | 93 | ＜30 | ＜10 | +++ |
| Cetomacrogol 1000 0 | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Macrogol 2000 0 | 25.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 69 | ＜30 | ＞10 | +++ |
| Tween 80 | 25.0 | 71 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 92 | ＜30 | ＜10 | +++ |
| Betacyclodextrin | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Poloxamer | 25.0 | 93 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Stearic acid | 25.0 | 78 | ＞30 | ＞10 | +++ |
| Sodium stearate | 25.0 | 78 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 25.0 | 67 | ＞30 | ＞10 | +++ |
| Lac | 25.0 | 67 | ＞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 |
| Cetomacrogol 1000 | 10.0 | 85 | ＜30 | ＞10 | ++ |
| Macrogol 4000 | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Polyethylene glycol 6000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Cetomacrogol 1000 0 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Macrogol 2000 0 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 71 | ＜30 | ＞10 | ++ |
| Tween 80 | 10.0 | 71 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 90 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 84 | ＜30 | ＞10 | +++ |
| Stearic acid | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Sodium stearate | 10.0 | 80 | ＞30 | ＞10 | +++ |
| Glycerin gelatine | 10.0 | 75 | ＞30 | ＞10 | +++ |
| Lac | 10.0 | 75 | ＞30 | ＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | 50 | 85 | ＜30 | ＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 50 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 78 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 25 | 90 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 93 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 88 | ＜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 | 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 | 88 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 25 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 88 | ＜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 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 92 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 87 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 86 | ＜30 | ＜10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 25 | 91 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | ＜30 | ＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 25 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | 10 | 92 | ＜30 | ＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 91 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 89 | ＜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 (2)
1. velvet deerhorn drip pill is prepared from together with Cornu Cervi Pantotrichum with as pharmaceutically suitable carrier of substrate, it is characterized in that:
(1) be unit with g or kg, it is an amount of to get Cornu Cervi Pantotrichum, adds the Diluted Alcohol reflux, extract, five times, each 2 hours, merge extractive liquid,, reclaiming ethanol and being concentrated into relative density is 1.3～1.35 thick paste, or continues to make drying, be ground into dry powder, promptly get the extract that contains 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 effective constituent of pilose antler and the ratio of substrate is 1: 3;
(3) accurately take by weighing described extract and substrate according to aforementioned proportion, 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 remains on 50 ℃～90 ℃, and the condensing agent cooling also remains on 40 ℃～-5 ℃;
When (5) temperature for the treatment of dropping-pill machine head and condensing agent reaches described state respectively, will contain fused solution and/or the emulsion and/or the suspension of described extract and substrate, place in the water dropper jar of drop pill machine, and splash in the condensing agent and shrink molding promptly.
2. velvet deerhorn drip 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100556189A CN1315460C (en) | 2005-03-21 | 2005-03-21 | Velvet deerhorn drip pill and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100556189A CN1315460C (en) | 2005-03-21 | 2005-03-21 | Velvet deerhorn drip pill and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1686169A CN1686169A (en) | 2005-10-26 |
| CN1315460C true CN1315460C (en) | 2007-05-16 |
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|---|---|---|---|
| CNB2005100556189A Expired - Fee Related CN1315460C (en) | 2005-03-21 | 2005-03-21 | Velvet deerhorn drip pill and its preparation method |
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| Country | Link |
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| CN (1) | CN1315460C (en) |
-
2005
- 2005-03-21 CN CNB2005100556189A patent/CN1315460C/en not_active Expired - Fee Related
Non-Patent Citations (3)
| Title |
|---|
| 中药药剂学，"滴丸" 范碧亭主编，380.383，上海科学技术出版社 1997 * |
| 国家药品监督管理局国家中成药标准汇编 中成药地方标准上升国家标准部分 国家药品监督管理局，211.212，国家药品监督管理局 2002 * |
| 国家药品监督管理局国家中成药标准汇编 中成药地方标准上升国家标准部分 国家药品监督管理局，211.212，国家药品监督管理局 2002;中药药剂学，"滴丸" 范碧亭主编，380.383，上海科学技术出版社 1997 * |
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| Publication number | Publication date |
|---|---|
| CN1686169A (en) | 2005-10-26 |
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