CN1682802A - Heart and brain health dripping pill for refreshing and strengthening brain and its preparing method - Google Patents
Heart and brain health dripping pill for refreshing and strengthening brain and its preparing method Download PDFInfo
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- CN1682802A CN1682802A CN 200510007418 CN200510007418A CN1682802A CN 1682802 A CN1682802 A CN 1682802A CN 200510007418 CN200510007418 CN 200510007418 CN 200510007418 A CN200510007418 A CN 200510007418A CN 1682802 A CN1682802 A CN 1682802A
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- Prior art keywords
- polyethylene glycol
- folium camelliae
- camelliae sinensis
- extract
- heart
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- 238000000034 method Methods 0.000 title claims description 23
- 238000005728 strengthening Methods 0.000 title abstract description 7
- 210000004556 brain Anatomy 0.000 title abstract description 5
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- Medicinal Preparation (AREA)
Abstract
The heart and brain health dripping pill has the functions of refreshing, strengthening brain and eliminating turbid substance, and is used in preventing and treating dizziness, chest stuffiness, hard breath, lack of strength, hypomnesis, etc. The heart and brain health dripping pill has tea extract as main material, and has high bioavailability, fast acting, and low cost.
Description
Technical field
The present invention relates to a kind of sharp clearly head that has, the refreshment brain-strengthening, change turbid effect for reducing fat, being used for control has a dizzy spell, sensation of oppression over the chest with shortness of breath, fatigue and weakness, lassitude, the pharmaceutical composition of diseases such as hypomnesis particularly is a kind of drug composition oral dropping pill formulation that raw material of Chinese medicine is prepared from the Folium Camelliae sinensis extract.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The heart and brain that the preparation method that provides among-the B-3151-98 is prepared from are good for sheet, be a kind of sharp clearly head that has, the refreshment brain-strengthening is changed turbid effect for reducing fat, being used for control has a dizzy spell, sensation of oppression over the chest with shortness of breath, fatigue and weakness, lassitude, the oral tablet of diseases such as hypomnesis, 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 drug standard WS
3Prescription that provides among-the B-3151-98 and technology and brief description:
Prescription: Folium Camelliae sinensis extract
Method for making: get Folium Camelliae sinensis extract 100g, add microcrystalline Cellulose (in 80～100 ℃ of dryings 4 hours) 100g, starch 94g, use 40% alcohol granulation, cold drying, adding magnesium stearate 1.5g, mixing is pressed into 1000, promptly.
Function cures mainly: the clear sharp head, the refreshment brain-strengthening is changed turbid blood fat reducing.Be used to have a dizzy spell, sensation of oppression over the chest with shortness of breath, fatigue and weakness, lassitude, diseases such as hypomnesis, has anticoagulant, promote fibrinogenolysis, prevent platelet adhesion, reduce the effect of plasma fibrin, the cardiovascular diseases is accompanied high fibrinogen syndrome and atherosclerosis, and the leukopenia due to tumor radiotherapy, the chemotherapy has preventive and therapeutic effect.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention, be to replenish to have now to be used for preventing and treating and have a dizzy spell, sensation of oppression over the chest with shortness of breath, fatigue and weakness, lassitude, the deficiency of disease oral drug preparations such as hypomnesis, a kind of bioavailability height is provided, and has quick release, fast produce effects, cheap, and free of contamination aborning drug composition oral preparation heart and brain health dripping pill.Heart and brain health dripping pill involved in the present invention is a raw material with the extract of Folium Camelliae sinensis, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain heart and brain health dripping pill involved in the present invention:
[preparation method]
1. the raw material that contains the Folium Camelliae sinensis active pharmaceutical ingredient: extract an amount of from the thick paste of Folium Camelliae sinensis, dried cream or dry powder;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as Polyethylene Glycol (2000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and Folium Camelliae sinensis extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing Folium Camelliae sinensis extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Folium Camelliae sinensis 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 Folium Camelliae sinensis 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.
[attached: the preparation of Folium Camelliae sinensis extract] gets the Folium Camelliae sinensis portion, adds 8～10 parts in water, and heating decocted 50 minutes, filter, add saturated Calx, water adjust pH to 9 after the filtrate cooling, left standstill 10 minutes, filter, taking precipitate adds diluted hydrochloric acid dissolution, and adjust pH to 4, filter, filtrate is extracted with the ethyl acetate jolting, reclaim under reduced pressure solution, and cold drying is promptly.
[character] this product is fawn-coloured amorphous powder, and abnormal smells from the patient is little puckery.This product is very easily dissolving in water, and is easily molten in ethanol and ethyl acetate.
Beneficial effect
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The heart and brain that the preparation method that provides among-the B-3151-98 is prepared from are good for sheet, be a kind of sharp clearly head that has, the refreshment brain-strengthening is changed turbid effect for reducing fat, being used for control has a dizzy spell, sensation of oppression over the chest with shortness of breath, fatigue and weakness, lassitude, the oral tablet of diseases such as hypomnesis, 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.
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.
Heart and brain health dripping pill involved in the present invention is compared with the strong sheet of heart and brain has following beneficial effect:
1. heart and brain health dripping pill involved in the present invention; utilize pharmaceutically suitable carrier such as Polyethylene Glycol to be substrate; make solid dispersion with the extract that contains the active effective ingredient of Folium Camelliae sinensis Chinese medicine; 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. heart and brain health 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. heart and brain health 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 heart and brain health dripping pill of the present invention.
First group: the test of single-matrix
1. the raw material that contains the Folium Camelliae sinensis active pharmaceutical ingredient: extract an amount of from the thick paste of Folium Camelliae sinensis, dried cream or dry powder;
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), 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 any one;
3. proportioning: with g or kg is unit, by weight, and Folium Camelliae sinensis extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the heart and brain health dripping pill of different size.
[result of the test]
Test 1: for observe Folium Camelliae sinensis extract and different substrates when 1: 1 the proportioning prepared heart and brain health dripping pill in qualitative difference, according to 1: 1 ratio, with Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe Folium Camelliae sinensis extract and different substrates when 1: 3 the proportioning prepared heart and brain health dripping pill in qualitative difference, according to 1: 3 ratio, with Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe Folium Camelliae sinensis extract and different substrates when 1: 9 the proportioning prepared heart and brain health dripping pill in qualitative difference, according to 1: 9 ratio, with Folium Camelliae sinensis 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 Folium Camelliae sinensis 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 raw material that contains the Folium Camelliae sinensis active pharmaceutical ingredient: extract an amount of from the thick paste of Folium Camelliae sinensis, dried cream or dry powder;
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 Folium Camelliae sinensis extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the heart and brain health dripping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe the mass discrepancy of Folium Camelliae sinensis extract and mixed-matrix obtained heart and brain health 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 12.
The group practices of table 1 Folium Camelliae sinensis extract and single-matrix
(Folium Camelliae sinensis 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 | ????61 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????73 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 6000 | ????50.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ????50.0 | ????75 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????74 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????70 | ????＜30 | ????＞10 | + |
| Poloxamer | ????50.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ????50.0 | ????71 | ????＜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 | ????61 | ????＞30 | ????＞10 | + |
| Lac | ????50.0 | ????61 | ????＞30 | ????＞10 | + |
The group practices of table 2 Folium Camelliae sinensis extract and single-matrix
(Folium Camelliae sinensis 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 | ????81 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????91 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????83 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Sodium lauryl sulphate | ????25.0 | ????79 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????71 | ????＞30 | ????＞10 | +++ |
The group practices of table 3 Folium Camelliae sinensis extract and single-matrix
(Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????82 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????81 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????75 | ????＜30 | ????＞10 | + |
The group practices of table 5 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????89 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????86 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????82 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????83 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????87 | ????＜30 | ????＜10 | ++ |
The group practices of table 8 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????92 | ????＜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 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????89 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????84 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and mixed-matrix
(Folium Camelliae sinensis 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 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
1. can be seen by the result in the table: when the ratio of Folium Camelliae sinensis 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 Folium Camelliae sinensis 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 Folium Camelliae sinensis extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (6)
- One kind be used for the control have a dizzy spell, sensation of oppression over the chest with shortness of breath, fatigue and weakness, lassitude, the pharmaceutical composition heart and brain health dripping pill of diseases such as hypomnesis is a raw material with the Folium Camelliae sinensis extract, be prepared from pharmaceutically suitable carrier as substrate, wherein:1.1 contain the extract of Folium Camelliae sinensis active pharmaceutical ingredient---extract an amount of from the thick paste of Folium Camelliae sinensis, dried cream or dry powder;1.2 substrate---Polyethylene Glycol (2000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of wherein one or more;1.3 proportioning---with g or kg is unit, by weight, and Folium Camelliae sinensis extract: substrate=1: 1～1: 9.
- 2. heart and brain health dripping pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
- 3. any heart and brain health dripping pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
- 4. the preparation method of a heart and brain health dripping pill is characterized in that being made of following process:4.1 contain the extract of Folium Camelliae sinensis active pharmaceutical ingredient: extract an amount of from the thick paste of Folium Camelliae sinensis, dried cream or dry powder;4.2 substrate: Polyethylene Glycol (2000～20000), polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of wherein one or more;4.3 proportioning: with g or kg is unit, by weight, and Folium Camelliae sinensis extract: substrate=1: 1～1: 9;4.4, accurately take by weighing drug extract and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing Folium Camelliae sinensis extract and substrate and/or emulsion and/or suspension;4.5 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) ℃;4.6 treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain Folium Camelliae sinensis extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, shrink molding promptly.
- 5. as the preparation method of heart and brain health dripping pill as described in the claim 4, it is characterized in that: method 4.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
- 6. the preparation method of heart and brain health dripping pill as claimed in claim 1 or heart and brain health dripping pill as claimed in claim 4 is characterized in that described Folium Camelliae sinensis extract is made by the method for being prepared as follows: get the Folium Camelliae sinensis portion, add 8～10 parts in water, heating decocted 50 minutes, filtered, and added saturated Calx after the filtrate cooling, water adjust pH to 9 left standstill 10 minutes, filtered, taking precipitate adds diluted hydrochloric acid dissolution, and adjust pH to 4, filtering, filtrate is extracted with the ethyl acetate jolting, reclaim under reduced pressure solution, cold drying are promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510007418 CN1682802A (en) | 2005-02-18 | 2005-02-18 | Heart and brain health dripping pill for refreshing and strengthening brain and its preparing method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510007418 CN1682802A (en) | 2005-02-18 | 2005-02-18 | Heart and brain health dripping pill for refreshing and strengthening brain and its preparing method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1682802A true CN1682802A (en) | 2005-10-19 |
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ID=35262421
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510007418 Pending CN1682802A (en) | 2005-02-18 | 2005-02-18 | Heart and brain health dripping pill for refreshing and strengthening brain and its preparing method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1682802A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
-
2005
- 2005-02-18 CN CN 200510007418 patent/CN1682802A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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