CN100542516C - Dropping pill of folium ilicis hainanensis and preparation method thereof - Google Patents
Dropping pill of folium ilicis hainanensis and preparation method thereof Download PDFInfo
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- CN100542516C CN100542516C CNB2005100827602A CN200510082760A CN100542516C CN 100542516 C CN100542516 C CN 100542516C CN B2005100827602 A CNB2005100827602 A CN B2005100827602A CN 200510082760 A CN200510082760 A CN 200510082760A CN 100542516 C CN100542516 C CN 100542516C
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Abstract
The invention discloses a kind of heat-clearing and toxic substances removing that has, the suppressing the hyperactive liver and subsiding YANG effect is used for vertigo and tinnitus, headache feeling of fullness in the head, the pharmaceutical composition of treatment for diseases such as susceptible to lose temper due to restlessness.Purpose of the present invention, be to replenish the existing vertigo and tinnitus that is used for the treatment of, the headache feeling of fullness in the head, the deficiency of the oral drug preparation of susceptible to lose temper due to restlessness provides a kind of bioavailability height, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations dropping pill of folium ilicis hainanensis.Dropping pill of folium ilicis hainanensis involved in the present invention is a raw material with the Folium Ilicis hainanensis, is prepared from the pharmaceutically suitable carrier as substrate.
Description
Technical field
The present invention relates to a kind of heat-clearing and toxic substances removing that has, the suppressing the hyperactive liver and subsiding YANG effect is used for vertigo and tinnitus, the headache feeling of fullness in the head, and the pharmaceutical composition of treatment for diseases such as susceptible to lose temper due to restlessness particularly is a kind of drug composition oral preparation that feedstock production forms with the Folium Ilicis hainanensis.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The mountain green tea decompression sheet that the preparation method that provides among-the B-2838-98 is prepared from, it is a kind of heat-clearing and toxic substances removing that has, the suppressing the hyperactive liver and subsiding YANG effect, be used for the treatment of vertigo and tinnitus, the headache feeling of fullness in the head, the oral tablet of susceptible to lose temper due to restlessness is 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 drug standard WS
3Prescription that provides among-the B-2838-98 and technology and brief description:
Prescription: this product is the sheet of Folium Ilicis hainanensis through being processed into.
Method for making: get green Flos Camelliae Japonicae, be ground into coarse powder, sieve, it is standby to get the 90g fine powder, and remaining coarse powder is solvent according to the percolation (appendix IO) under fluid extract and the extractum item with 70% ethanol, flood and carry out diafiltration after 18 hours, to the filtrate color light till, decompression filtrate recycling ethanol also is concentrated into the thick paste shape, add above-mentioned fine powder and an amount of starch, mixing, system granule, dry, be pressed into 1000, sugar coating, promptly.
Function cures mainly: heat-clearing and toxic substances removing, suppressing the hyperactive liver and subsiding YANG.Be used for vertigo and tinnitus, headache feeling of fullness in the head, susceptible to lose temper due to restlessness.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish the existing vertigo and tinnitus that is used for the treatment of, the headache feeling of fullness in the head, the deficiency of the oral drug preparation of susceptible to lose temper due to restlessness provides a kind of bioavailability height, and has a quick release, quick produce effects, medicament contg height, taking convenience, cheap, and free of contamination aborning oral formulations dropping pill of folium ilicis hainanensis.Dropping pill of folium ilicis hainanensis involved in the present invention is a raw material with the Folium Ilicis hainanensis, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain dropping pill of folium ilicis hainanensis involved in the present invention:
[preparation method]
1. the preparation of drug extract: get green Flos Camelliae Japonicae, be ground into coarse powder, according to the percolation under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and the extractum item, with 70% ethanol is solvent, flood to carry out diafiltration after 18 hours, to the filtrate color light till, filtrate is reclaimed ethanol and is concentrated into the thick paste shape being decompressed under the 0.1MPa condition, or continue to make drying, be ground into dry powder, promptly;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1:1～1:9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The mountain green tea decompression sheet that the preparation method that provides among-the B-2838-98 is prepared from, it is a kind of heat-clearing and toxic substances removing that has, the suppressing the hyperactive liver and subsiding YANG effect, be used for the treatment of vertigo and tinnitus, the headache feeling of fullness in the head, the oral tablet of susceptible to lose temper due to restlessness is through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Dropping pill of folium ilicis hainanensis involved in the present invention is compared with the mountain green tea decompression sheet has following beneficial effect;
1. dropping pill of folium ilicis hainanensis involved in the present invention; utilize surfactant to be substrate; make solid dispersion with the extract that contains the Folium Ilicis hainanensis effective 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. dropping pill of folium ilicis hainanensis 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. dropping pill of folium ilicis hainanensis 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 dropping pill of folium ilicis hainanensis of the present invention.
[first group: the test of single-matrix]
1. raw material: with reference to preparation method 1, it is standby to make the extract dry powder that contains the Folium Ilicis hainanensis effective ingredient in advance;
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
1000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1:1～1:9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the dropping pill of folium ilicis hainanensis of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when the proportioning of 1:1 prepared dropping pill of folium ilicis hainanensis in qualitative difference, according to the ratio of 1:1, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
1000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when the proportioning of 1:3 prepared dropping pill of folium ilicis hainanensis in qualitative difference, according to the ratio of 1:3, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when the proportioning of 1:9 prepared dropping pill of folium ilicis hainanensis in qualitative difference, according to the ratio of 1:9, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
1000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: with reference to preparation method 1, it is standby to make the extract dry powder that contains the Folium Ilicis hainanensis effective ingredient in advance;
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 dropping pill of folium ilicis hainanensis of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared dropping pill of folium ilicis hainanensis when the proportioning of 1:1, 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 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 dropping pill of folium ilicis hainanensis when the proportioning of 1:3, 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 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 dropping pill of folium ilicis hainanensis when the proportioning of 1:9, 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 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 dropping pill of folium ilicis hainanensis when the proportioning of 1:1, 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 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 dropping pill of folium ilicis hainanensis when the proportioning of 1:3, 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 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 dropping pill of folium ilicis hainanensis when the proportioning of 1:9, 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 different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experiments and the results are shown in Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared dropping pill of folium ilicis hainanensis when the proportioning of 1:1, 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 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 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared dropping pill of folium ilicis hainanensis when the proportioning of 1:3, 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 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 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared dropping pill of folium ilicis hainanensis when the proportioning of 1:9, 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 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 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 | 69 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 50.0 | 85 | <30 | >10 | + |
| Polyethylene Glycol 6000 | 50.0 | 85 | <30 | >10 | + |
| Polyethylene Glycol 10000 | 50.0 | 85 | <30 | >10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 84 | <30 | >10 | ++ |
| Span 40 | 50.0 | 63 | <30 | >10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | <30 | >10 | ++ |
| Poloxamer | 50.0 | 78 | <30 | >10 | ++ |
| Sodium lauryl sulphate | 50.0 | 75 | >30 | >10 | ++ |
| Stearic acid | 50.0 | 61 | >30 | >10 | ++ |
| Sodium stearate | 50.0 | 61 | >30 | >10 | ++ |
| Glycerin gelatine | 50.0 | 60 | >30 | >10 | + |
| Lac | 50.0 | 60 | >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 | 73 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 25.0 | 88 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 25.0 | 88 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 88 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 87 | <30 | <10 | +++ |
| Span 40 | 25.0 | 75 | <30 | >10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 87 | <30 | <10 | ++ |
| Poloxamer | 25.0 | 87 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 25.0 | 73 | <30 | >10 | ++ |
| Stearic acid | 25.0 | 75 | >30 | >10 | +++ |
| Sodium stearate | 25.0 | 74 | >30 | >10 | +++ |
| Glycerin gelatine | 25.0 | 73 | >30 | >10 | +++ |
| Lac | 25.0 | 73 | >30 | >10 | +++ |
The group practices of table 3 drug extract and single-matrix
(drug extract: substrate=1:9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 10.0 | 83 | <30 | >10 | + |
| Polyethylene Glycol 4000 | 10.0 | 90 | <30 | <10 | ++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 89 | <30 | <10 | +++ |
| Span 40 | 10.0 | 73 | <30 | <10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 87 | <30 | <10 | ++ |
| Poloxamer | 10.0 | 89 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 10.0 | 78 | <30 | >10 | +++ |
| Stearic acid | 10.0 | 77 | >30 | >10 | +++ |
| Sodium stearate | 10.0 | 75 | >30 | >10 | +++ |
| Glycerin gelatine | 10.0 | 73 | >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 | 83 | <30 | >10 | ++ |
| Poloxamer: Polyethylene Glycol=1:1 | 50 | 84 | <30 | >10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:1 | 50 | 83 | <30 | >10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1:1 | 50 | 77 | <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 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:1 | 25 | 84 | <30 | >10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1:9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1:1 | 10 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:1 | 10 | 90 | <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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:5 | 50 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:5 | 50 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:5 | 50 | 86 | <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 | 90 | <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 | 92 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:5 | 10 | 92 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:5 | 10 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:5 | 10 | 89 | <30 | <10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1:1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1:10 | 50 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1:10 | 50 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:10 | 50 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:10 | 50 | 87 | <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 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1:10 | 25 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1:10 | 25 | 86 | <30 | <10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1:9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1:10 | 10 | 92 | <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 | 89 | <30 | <10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1:1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1:3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1:9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. a dropping pill of folium ilicis hainanensis is a raw material with the Folium Ilicis hainanensis, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) gets green Flos Camelliae Japonicae, be ground into coarse powder, according to the percolation under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and the extractum item, be solvent with 70% ethanol, flood and carry out diafiltration after 18 hours, to the filtrate color light till, filtrate is reclaimed ethanol and is concentrated into the thick paste shape being decompressed under the 0.1MPa condition, or continues to make drying, is ground into dry powder, promptly get the extract that contains the Folium Ilicis hainanensis 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 40 ℃～-5 ℃;
When (5) treating that dropping-pill machine head and condensing agent reach described state of temperature 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 into and shrink molding in the condensing agent, promptly.
2. dropping pill of folium ilicis hainanensis 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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| CNB2005100827602A CN100542516C (en) | 2005-07-12 | 2005-07-12 | Dropping pill of folium ilicis hainanensis and preparation method thereof |
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| CN100408066C (en) * | 2006-03-15 | 2008-08-06 | 北京科信必成医药科技发展有限公司 | Preparing process and product of Chinese medicine dripping pill with tea extract |
| CN105456978A (en) * | 2015-12-08 | 2016-04-06 | 肇庆医学高等专科学校 | Common cold curing tea drop pill and preparation method thereof |
| CN105434379A (en) * | 2015-12-08 | 2016-03-30 | 肇庆医学高等专科学校 | Five flower tea dropping pill and preparation method thereof |
| CN105456316A (en) * | 2015-12-08 | 2016-04-06 | 肇庆医学高等专科学校 | Plumeria rubra drop pill and preparation method thereof |
| CN105432885A (en) * | 2015-12-08 | 2016-03-30 | 肇庆医学高等专科学校 | Dried tangerine or orange peel tea dropping pill and preparation method thereof |
| CN105412032A (en) * | 2015-12-08 | 2016-03-23 | 肇庆医学高等专科学校 | Twenty-four flavored cool tea drop pill and preparation method thereof |
| CN105412033A (en) * | 2015-12-08 | 2016-03-23 | 肇庆医学高等专科学校 | Screwtree root tea dropping pill and preparation method thereof |
| CN105494788A (en) * | 2015-12-08 | 2016-04-20 | 肇庆医学高等专科学校 | Chinese cymbidium herbal tea dropping pill and preparation method thereof |
| CN105454577A (en) * | 2015-12-08 | 2016-04-06 | 肇庆医学高等专科学校 | Christina loosestrife herbal tea dropping pills and preparation method thereof |
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