CN102772382B - Ophiopogonin dropping pill and preparation method thereof - Google Patents
Ophiopogonin dropping pill and preparation method thereof Download PDFInfo
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- CN102772382B CN102772382B CN 201210294911 CN201210294911A CN102772382B CN 102772382 B CN102772382 B CN 102772382B CN 201210294911 CN201210294911 CN 201210294911 CN 201210294911 A CN201210294911 A CN 201210294911A CN 102772382 B CN102772382 B CN 102772382B
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Abstract
The invention discloses an ophiopogonin dropping pill and a preparation method thereof. The ophiopogonin dropping pill is prepared from ophiopogonin, proper matrix for preparing the dropping pill and a solubilizer. The method comprises the following steps of: adding the ophiopogonin into the molten matrix, uniformly stirring, and dropping to prepare pills; and cooling in a coolant, and drying to obtain the ophiopogonin dropping pill. The ophiopogonin can be prevented from absorbing moisture, so that the bioavailability is increased; and the ophiopogonin dropping pill has the characteristics of high dissolving speed, high bioavailability, small side effect, high medicine stability, simplicity in operation and improvement on the medicine taking compliance of patients.
Description
Technical field
The present invention relates to a kind of dropping pill formulation technology of medicine, particularly a kind of ophiopogonin D drop pill and preparation method thereof.
Background technology
Cardiovascular disease is listed as first of each large disease, the serious harm human physical and mental health, and the sequela that causes is also brought great misery to patient and family members, becomes the social problem of a worth extensive concern.Countries in the world medicine worker constantly studies, and prevention and the rehabilitation medicine of medicine, the especially cardiovascular disease of exploitation treatment cardiovascular and cerebrovascular disease can obtain the effective treatment cardio-cerebral vascular disease patient.Therefore the research and development of cardiovascular and cerebrovascular diseases medicine are not only being healed the wounded and rescue the dying, are being had and important social meaning aspect the rehabilitation, but also have significant economic benefit.
Chinese medicine is used for the treatment of and prevents cardiovascular and cerebrovascular disease and sequela in China long history to be arranged, and they have determined curative effect, the advantage that toxic and side effects is little.Ophiopogonin is exactly one of them, and ophiopogonin is the saponin component that extracts in Radix Ophiopogonis.Always in Chinese medicine folk prescription and compound preparation play very important effect as the main medicine for the treatment of cardiovascular and cerebrovascular vessel Radix Ophiopogonis.In important Chinese medicine cardiovascular medicament SHENGMAI YIN commonly used, SHENGMAI ZHUSHEYE, SHENMAI ZHUSHEYE, the Radix Ophiopogonis preparation such as injection all as main medicinal application.
Application publication number: 102558284A discloses a kind of extracting method of ophiopogonin D, comprise and get dry pulverizing medicinal materials Radix Ophiopogonis, alcohol extraction, water-saturated n-butanol extraction, acetone precipitation, filter, the filtrate evaporate to dryness gets Radix Ophiopogonis total saponins, adopt again high-speed countercurrent chromatography that it is carried out separation and purification, get the method for ophiopogonin D product; Do not relate to ophiopogonin D drop pill and preparation method thereof.Application publication number: 101327221 disclose medical usage, the application publication number of ophiopogonin D as tissue factor approach restrainer: 101084913 disclose application, the application publication number of ophiopogonin D in preparation vascular endothelial cells regulating signal transduction genomic medicine: 101088507 disclose application, the application publication number of ophiopogonin D in preparation regulating vascular endothelial cell cycle genes medicine: 101088506 disclose the application of ophiopogonin D in preparation regulating vascular endothelial cell functional gene medicine, all do not relate to ophiopogonin D drop pill and preparation method thereof; Literature search also finds no the report that closes ophiopogonin D drop pill and preparation method thereof.
Ophiopogonin D is white amorphous powder, bitter in the mouth, have draw moist.This product is dissolved in methanol and ethanol, and is slightly molten in water.Ophiopogonin D is made drop pill, can prevent the ophiopogonin D moisture absorption, have that dissolution rate is fast, bioavailability is high, side effect is little, medicine stability is high, characteristics of easy operating, increase patient medication compliance.
Summary of the invention
The object of the invention is to prevent the ophiopogonin D moisture absorption by making the ophiopogonin D drop pill, improve the bioavailability of ophiopogonin D, bring into play quick-acting, long-acting effect; The present invention also provides a kind of preparation method of ophiopogonin D drop pill.
Technical scheme of the present invention is as follows:
A kind of ophiopogonin D drop pill is to be made by ophiopogonin D, suitable substrate and solubilizing agent of making drop pill.
The used substrate of ophiopogonin D drop pill of the present invention comprises and is selected from polyethylene glycols;
The used solubilizing agent of ophiopogonin D drop pill of the present invention is selected from one or more in the water solublity pharmaceutical carriers such as poloxamer;
The used coolant of ophiopogonin D drop pill of the present invention includes but not limited to one or more in liquid paraffin, dimethicone 100, dimethicone 50, vegetable oil, the kerosene.
The mass ratio of ophiopogonin D and substrate is 1:(4.5-5.5 in the drop pill of the present invention), the mass ratio of ophiopogonin D and solubilizing agent is 1:(0.36-0.48).
It is preferred according to the present invention,
A kind of ophiopogonin D drop pill is to be made by ophiopogonin D, suitable substrate and solubilizing agent of making drop pill.
Described ophiopogonin D is crossed 100 mesh sieves, and is for subsequent use.
It is preferred according to the present invention,
The mass ratio of ophiopogonin D and substrate is 1:5 in the drop pill of the present invention.
Described substrate polyethylene glycols is the combination of Macrogol 4000 and polyethylene glycol 6000, and wherein the mass ratio of Macrogol 4000 and polyethylene glycol 6000 is 3:1; The solubilizing agent poloxamer is PLURONICS F87, and the mass ratio of its Chinese medicine and PLURONICS F87 is 1:0.42.
A kind of preparation method of ophiopogonin D drop pill, step is as follows:
(1) get ophiopogonin D, cross the 100-120 mesh sieve, for subsequent use;
(2) place heating container to be heated to while stirring melting substrate and solubilizing agent, add again ophiopogonin D and the stirring of step (1) gained, until obtain the fused solution of medicine and substrate and solubilizing agent, for subsequent use;
(3) temperature of adjustment pill dripping machine makes the water dropper temperature of pill dripping machine remain on 75～85 ℃, and the temperature of condensing agent remains on 10～25 ℃, water dropper internal diameter bore 1-5mm;
(4) temperature of pill dripping machine water dropper and condensation column inner condensat liquid is stablized respectively when being in the desired state of temperature of step (3), the fused solution that contains medicine and substrate and solubilizing agent that step (2) is obtained, place in the water dropper tank of pill dripping machine, splash in the condensed fluid by water dropper;
(5) export the drop pill that will shrink molding by pill dripping machine and take out, remove condensed fluid, drying, and get final product.
It is preferred according to the present invention,
A kind of preparation method of ophiopogonin D drop pill, step is as follows:
(1) get ophiopogonin D, cross 100 mesh sieves, for subsequent use;
(2) place heating container to be heated to while stirring melting substrate Macrogol 4000, polyethylene glycol 6000, solubilizing agent PLURONICS F87, the ophiopogonin D and the stirring that add again step (1) gained, until obtain the fused solution of medicine and substrate and solubilizing agent, for subsequent use;
(3) temperature of adjustment pill dripping machine makes the water dropper temperature of pill dripping machine remain on 75～85 ℃, and the temperature of condensing agent remains on 10～25 ℃, water dropper internal diameter bore 2mm;
(4) temperature of pill dripping machine water dropper and condensation column inner condensat liquid is stablized respectively when being in the desired state of temperature of step (3), will be contained the fused solution of medicine and substrate and solubilizing agent, place in the water dropper tank of pill dripping machine, splash in the condensed fluid by water dropper;
(5) export the drop pill that will shrink molding by pill dripping machine and take out, remove condensed fluid, drying, and get final product.
The described condensed fluid of step (4) is liquid paraffin and dimethicone 100 mixture, and its Volume fraction is 3:1.
The unit of above weight portion and parts by volume is grams per milliliter.
Supplementary material of the present invention is commercial product, and pill dripping machine is conventional products in the prior art.
Ophiopogonin D is made drop pill, because of medicine in drop pill by embedding can Effective Raise the stability of medicine; We have added water-soluble base in the preparation prescription of drop pill in addition, have significantly increased the dissolving out capability of medicine, have improved drug bioavailability high.To sum up, drop pill of the present invention has that dissolution rate is fast, bioavailability is high, side effect is little, medicine stability is high, the characteristics of easy operating; Detailed experimental data will be in the specific embodiment comparative illustration in addition.
The specific embodiment
Following embodiment and experimental example are used for further specifying but are not limited to the present invention.
Embodiment 1,
A kind of ophiopogonin D drop pill is made by the supplementary material of following weight portion:
Be prepared as follows and form:
(1) get ophiopogonin D, cross 100 mesh sieves, for subsequent use;
(2) place heating container to be heated to while stirring melting substrate Macrogol 4000, polyethylene glycol 6000, solubilizing agent PLURONICS F87, the ophiopogonin D and the stirring that add again step (1) gained, until obtain the fused solution of medicine and substrate and solubilizing agent, for subsequent use;
(3) temperature of adjustment pill dripping machine makes the water dropper temperature of pill dripping machine remain on 75～85 ℃, and the temperature of condensed fluid remains on 10～25 ℃, water dropper internal diameter bore 2mm;
(4) temperature of pill dripping machine water dropper and condensation column inner condensat liquid is stablized respectively when being in the desired state of temperature of step (3), will be contained the fused solution of medicine and substrate and solubilizing agent, place in the water dropper tank of pill dripping machine, splash in the condensed fluid by water dropper;
(5) export the drop pill that will shrink molding by pill dripping machine and take out, remove condensed fluid, drying, and get final product.
The described condensed fluid of step (4) is that liquid paraffin and dimethicone 100 volume of mixture portion rates are 3:1.
Embodiment 2,
A kind of ophiopogonin D drop pill is made by the supplementary material of following weight portion:
Preparation method is with embodiment 1.
Embodiment 3,
A kind of ophiopogonin D drop pill is made by the supplementary material of following weight portion:
Preparation method is with embodiment 1.
Embodiment 4,
A kind of ophiopogonin D drop pill is made by the supplementary material of following weight portion:
Ophiopogonin D 1g
Macrogol 4000 5.5g
PLURONICS F87 0.42g
Preparation method is with embodiment 1.Difference is that the substrate that adds in the step (2) is Macrogol 4000.
Embodiment 5,
A kind of ophiopogonin D drop pill is made by the supplementary material of following weight portion:
Ophiopogonin D 1g
Polyethylene glycol 6000 5g
PLURONICS F87 0.48g
Preparation method is with embodiment 1.Difference is that the substrate that adds in the step (2) is polyethylene glycol 6000.
Experimental example 1, the test of preparation prescription craft screening
1, preparation prescription mesostroma kind is selected test
Select the different substrates kind to test take medicine deployment conditions, dripping complexity and made drop pill appearance character in substrate as index, result of the test is as follows.
Substrate is respectively Macrogol 4000 (PEG4000), polyethylene glycol 6000 (PEG6000), PEG4000+PEG6000, and medicine and substrate composition are 1:5, and 75～85 ℃ of dripping temperature, the temperature of condensing agent remain on 10～25 ℃.
Table 1 matrix species is selected result of the test
According to above-mentioned result of the test: with PEG4000 as substrate, medicine difficulties in dispersion, and the smooth rounding property of made drop pill is poor; With PEG6000 and PEG4000+PEG6000(3:2) as substrate, the equal thickness of medicinal liquid after disperseing is difficult for dripping; Use PEG4000+PEG6000(3:1) as substrate, the medicinal liquid stickiness is suitable after disperseing, and a small amount of caking is arranged, and made drop pill is than rounding.Therefore we tentatively select PEG4000+PEG6000(3:1) as the substrate of this product, in order further to increase the dispersion of medicine in substrate, in prescription, add the solubilizing agent PLURONICS F87 and proceed test.
2, solubilizing agent consumption screening test in the preparation prescription
According to above result of the test, in prescription, add solubilizing agent, to increase the dispersion of medicine in substrate, simultaneously screening test is carried out in the consumption of solubilizing agent in the prescription, disperse complexity and made drop pill appearance character as index in substrate take medicine, result of the test is as follows.
Matrix species is selected PEG4000+PEG6000(3:1), PLURONICS F87 is selected in solubilizing agent, and 75～85 ℃ of dripping temperature, the temperature of condensed fluid remain on 10～25 ℃.
Table 2 substrate and solubilizing agent consumption screening test result
According to above result of the test, in prescription, behind the adding solubilizing agent PLURONICS F87, can obviously improve the dispersion of medicine in substrate, the smooth rounding rate of made drop pill is desirable.Therefore we determine that the consumption of solubilizing agent in this preparation prescription is: the amount ranges of medicine and solubilizing agent is 1:(0.36-0.48), preferred agents and solubilizing agent amount ratio are 1:0.42.
3, preparation prescription mesostroma consumption is selected test
Select test and solubilizing agent consumption to select test by matrix species, we determine the preferred PEG4000+PEG6000(3:1 of preparation prescription mesostroma), the preferred PLURONICS F87 of solubilizing agent, and medicine and solubilizing agent amount ratio are 1:10, we do further definite by test to the consumption of prescription mesostroma.This test is selected as index take appearance character, the dissolve scattered time limit of made drop pill, and result of the test is as follows.
This test Chinese medicine and PLURONICS F87 amount ratio are 1:0.42, and 75～85 ℃ of dripping temperature, the temperature of condensing agent remain on 10～25 ℃.
Table 3 preparation prescription mesostroma consumption is selected test
According to above result of the test, the amount ratio of medicine and substrate is 1:(4.5-5.5) time, the dissolve scattered time limit of made drop pill is all qualified, and smooth rounding rate is all more than 90%, therefore we determine that the amount ratio of prescription Chinese medicine and substrate is 1:(4.5-5.5), preferred agents is 1:5 with the substrates quantity ratio.
4, condensed fluid is selected test in the preparation process
Condensed fluid is the important auxiliary agent of drop pill, its density and viscosity directly affect the sedimentation velocity of medicinal liquid and the roundness of drop pill, we are with the decrease speed of made drop pill in condensed fluid and the appearance character index of drop pill, condensed fluid liquid paraffin and dimethicone are carried out screening test, and the result is as follows.
Condensed fluid selection result in table 4 preparation process
Select liquid paraffin, dimethicone 100 to mix as condensed fluid according to above result of the test, the roundness of sedimentation velocity and drop pill is good, make as condensed fluid therefore select liquid paraffin and dimethicone 100 to mix, and both volume parts is than being 3:1.
5, the selection of condensate temperature in the preparation process thereof
In the preparation process of drop pill, the temperature of dripping temperature and condensed fluid is on the impact that forms of drop pill, we are defined as 75～85 ℃ with the dripping temperature, and the phenomenon of observing in the dripping process is selected the temperature of condensing agent by test as index, and the result is as follows.
Dripping temperature and condensate temperature are selected test in table 5 preparation process thereof
| Tested number | Condensate temperature (℃) | Phenomenon |
| 1 | 30 | Viscous |
| 2 | 25 | Molding is good |
| 3 | 20 | Molding is good |
| 4 | 15 | Molding is good |
| 5 | 10 | Molding is good |
| 6 | -2 | The cavity |
According to the cooling of the temperature of above result of the test condensed fluid and remain on 10～25 ℃, the drop pill molding is good.
6, the selection of water dropper bore test in the preparation process thereof
Take the drop pill character and the ball method of double differences is different as index the drop pill bore is selected, the result is as follows.
The water dropper bore is selected result of the test in table 6 preparation process thereof
When being (internal diameter) 2mm according to above result of the test water dropper bore, the smooth rounding of made drop pill, and the ball method of double differences different be 6.2%, within the limit of pharmacopeia regulation.
To sum up, through the test of preparation prescription craft screening, determine this drop pill prescription mesostroma preferred mass than 3:1 Macrogol 4000 and polyethylene glycol 6000 mixed-matrix, its consumption is preferred, and medicine and PEG4000 and PEG 6000 mixed-matrix weight ratios are 1:5; The preferred PLURONICS F87 of solubilizing agent, its consumption is preferred, and medicine and PLURONICS F87 mass ratio are 1:0.42.
In the technological parameter, preferred 75～85 ℃ of dripping temperature; The preferred liquid of condensed fluid is that Volume fraction is 3:1 paraffin body and dimethicone 100 mixed liquors, preferred 10～25 ℃ of the chilling temperature of condensing agent; Preferred (internal diameter) 2mm of water dropper bore carries out dripping.
Experimental example 2: stability test research data
Requirement according to " Chinese medicine, natural drug pilot scale research technological guidance principle " relevant stability study, we have carried out acceleration for stabilization Journal of Sex Research and Journal of Sex Research steady in a long-term to embodiment 1,2,3 batches of ophiopogonin D drop pill samples of 3, and results of stability is as follows:
One, reagent and sample
1, test sample
The ophiopogonin D drop pill of embodiment 1, product batch number: 110314,110315,, 110316; The ophiopogonin D drop pill of embodiment 1, product batch number: 110321,110322,110323; The ophiopogonin D drop pill of embodiment 1, product batch number: 110328,110329,110330.
2, reagent and reagent
The ophiopogonin D reference substance, self-control.
Reagent: liquid phase is chromatographically pure with reagent, and other are analytical pure.
Two, test method
1, accelerated test
With the test sample of embodiment 1-3 respectively under simulation listing terms of packing, in the accelerated test condition (40 ℃, RH75%) the lower placement, later on respectively at 0,1,2,3, investigate June.
2, long term test
With the test sample of embodiment 1-3 respectively under simulation listing terms of packing, room temperature place (25 ℃, RH60%), later on respectively at 0,3,6, December investigates.
Three, investigation project
Investigation project: character, assay.
Four, result of the test and conclusion
During the three batches of ophiopogonin D drop pill sample accelerated tests 6 months and long term test were investigated in 12 months, every quality index has no significant change, and was basicly stable.The results are shown in Table 7,8,9,10,11,12.
1 three batches of ophiopogonin D drop pill of table 7 embodiment accelerated test is investigated the result
The ophiopogonin D drop pill accelerated test of table 8 embodiment 2 is investigated the result
The ophiopogonin D drop pill accelerated test of table 9 embodiment 3 is investigated the result
The result is investigated in the ophiopogonin D drop pill room temperature stability test of table 10 embodiment 1
The result is investigated in the ophiopogonin D drop pill room temperature stability test of table 11 embodiment 2
The result is investigated in the ophiopogonin D drop pill room temperature stability test of table 12 embodiment 3
Claims (4)
1. ophiopogonin D drop pill it is characterized in that by ophiopogonin D, mass ratio being that substrate, the solubilizing agent PLURONICS F87 that 3: 1 Macrogol 4000 and polyethylene glycol 6000 form made; Ophiopogonin D in the drop pill is crossed 100 mesh sieves, and the mass ratio of ophiopogonin D and substrate is 1: (4.5-5.5), the mass ratio of ophiopogonin D and solubilizing agent is 1: (0.36-0.48), condensed fluid is the mixture of liquid paraffin and dimethicone 100.
2. a kind of ophiopogonin D drop pill as claimed in claim 1 is characterized in that, the mass ratio of ophiopogonin D and substrate is 1: 5 in the drop pill; The mass ratio of ophiopogonin D and PLURONICS F87 is 1: 0.42.
3. a kind of ophiopogonin D drop pill as claimed in claim 1 is characterized in that, the Volume fraction of described condensed fluid liquid paraffin and dimethicone 100 is 3: 1, and the temperature of condensing agent remains on 10～25 ℃.
4. a kind of ophiopogonin D drop pill as claimed in claim 1 is characterized in that being made by the supplementary material of following weight portion:
Be prepared as follows and form:
A kind of preparation method of ophiopogonin D drop pill, step is as follows:
(1) get ophiopogonin D, cross 100 mesh sieves, for subsequent use;
(2) place heating container to be heated to while stirring melting substrate Macrogol 4000, polyethylene glycol 6000, solubilizing agent PLURONICS F87, the ophiopogonin D and the stirring that add again step (1) gained, until obtain the fused solution of medicine and substrate and solubilizing agent, for subsequent use;
(3) temperature of adjustment pill dripping machine makes the water dropper temperature of pill dripping machine remain on 75～85 ℃, and the temperature of condensing agent remains on 10～25 ℃, water dropper internal diameter bore 2mm;
(4) temperature of pill dripping machine water dropper and condensation column inner condensat liquid is stablized respectively when being in the desired state of temperature of step (3), the fused solution that will contain medicine and substrate and solubilizing agent, place in the water dropper tank of pill dripping machine, splash in the condensed fluid by water dropper;
(5) export the drop pill that will shrink molding by pill dripping machine and take out, remove condensed fluid, drying, and get final product;
The described condensed fluid of step (4) is liquid paraffin and dimethicone 100 mixture, and its Volume fraction is 3: 1.
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| CN104688699A (en) * | 2015-02-15 | 2015-06-10 | 桂林医学院 | Curculigoside dropping pill and preparation method thereof |
| CN110664828A (en) * | 2019-05-16 | 2020-01-10 | 中国人民解放军军事科学院军事医学研究院 | Ophiopogon japonicus saponin D preparation and new application of hypoglycemic drug thereof |
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| CN1290508C (en) * | 2005-05-13 | 2006-12-20 | 张海峰 | Traditional Chinese medicinal preparation for treating chronic bronchitis, its preparation method and application |
| CN101085188B (en) * | 2006-06-08 | 2011-07-13 | 天津天士力之骄药业有限公司 | Method for preparing total saponins of radix ophiopogonis |
| CN101879274B (en) * | 2010-07-12 | 2012-10-17 | 哈尔滨吉尔生物科技有限公司 | Medicine composition containing red ginseng saponin extract and radix ophiopogonis saponin extract as well as preparation method and application thereof |
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