CN102755365B - Blood circulating and pain relieving dropping pill with functions of activating blood circulation to dissipate blood stasis and relieving swelling and pain and preparation method of pill - Google Patents
Blood circulating and pain relieving dropping pill with functions of activating blood circulation to dissipate blood stasis and relieving swelling and pain and preparation method of pill Download PDFInfo
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Abstract
The invention discloses a blood circulating and pain relieving dropping pill with functions of activating blood circulation to dissipate blood stasis and relieving swelling and pain, and in particular relates to a drug composition (namely oral dropping pill preparation) which is based on traditional Chinese medicine set prescription (namely blood circulating and pain relieving capsules and blood circulating and pain relieving tablets) and is modified by dosage form. The invention aims at providing the drug composition oral preparation (namely the blood circulating and pain relieving dropping pill), and according to the dropping pill, the defect that the conventional oral drug preparation for treating the diseases can be overcome, the bioavailability is high, the drug can be released rapidly, the effect can be shown rapidly, the toxic and side effects are small, the drug content is high, the taking dosage is small and accurate, the drug taking is convenient, the cost is low, and the dropping pill can be taken out conveniently.
Description
Technical field
The invention belongs to the pharmaceutical technology field, be specifically related to a kind of have promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect, pharmaceutical composition for traumatic injury, congestion detumescence, be particularly related to that to take Traditional Chinese medicine historical preparation HUOXUE ZHIRONG JIAONANG and promoting blood circulation and stopping pain tablet be basis, a kind of drug composition oral dropping pill formulation formed through the dosage form transformation of the way.
Background technology
HUOXUE ZHIRONG JIAONANG or blood-activating pain stopping tablet change dosage form by huoxue zhitong powder, huoxue zhitong san and develop, former side comes from Tang's Sun Simiao " prescriptions worth thousand gold ", formed by Six-element Chinese medicines such as Radix Angelicae Sinensis, Radix Notoginseng, Olibanum (system), Borneolum Syntheticum, Eupolyphaga Seu Steleophaga, Pyritums (forging), gone through an edition pharmacopeia and record since 1977.
According to national drug standards WS
3the HUOXUE ZHIRONG JIAONANG that the formula provided in-091 (Z-81)-95 (Z) and production technology are prepared from, a kind of have promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect: for the capsule class preparation of traumatic injury, congestion detumescence, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.
Below drug standard WS
3formula and the production technology of the HUOXUE ZHIRONG JIAONANG provided in-091 (Z-81)-95 (Z):
Nomenclature of drug: HUOXUE ZHIRONG JIAONANG
Prescription: Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum 120g;
Method for making: above Six-element, except Borneolum Syntheticum, the ground spices such as all the other Radix Angelicae Sinensis are broken into fine powder; By the Borneolum Syntheticum porphyrize, with above-mentioned powder facing-up, sieve, mix, incapsulate, make 1800, both;
Character: this product is capsule, and content is the taupe powder; Gas perfume, acrid in the mouth, bitter cool.
Function cures mainly: promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain: for traumatic injury, congestion detumescence
Usage and dosage: with warm yellow wine or warm water delivery service, one time 2,3 times on the one.
The preparation of above-mentioned HUOXUE ZHIRONG JIAONANG, be to incapsulate after ingredients is pulverized, and makes capsule formulation, because this medicine medical material used is not purified or leaching process, is all that crude drug is used as medicine, so the patient has increased toxicity after taking, side effect increases.In addition, due to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, take and all exist that dissolve scattered time limit is long, dissolution is low, it is poor to absorb afterwards, liver sausage first pass effect and the problem such as bioavailability is lower, thereby affect the performance of drug effect, also directly affect therapeutic effect.As syrup preparation contains higher sugar, be unfavorable for diabetic to take; Granule contains dust; Chinese medicine untoward reaction consequence is serious, cause anaphylactic shock and rank first place, and the trend increased is arranged year by year, this and apply clinically more relevant.Chinese medicine comparison of ingredients complexity, inject human body by this mixture from blood vessel, forces human body to go metabolism, and itself has just had potential danger, if again with the other medicines compatibility, contingent reaction often is difficult to prediction.
In addition, conventional peroral dosage form as tablet, capsule etc., due to the technique that granulation is arranged, therefore can produce larger 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 social general health level.
Summary of the invention
Purpose of the present invention, be to supplement the deficiency of existing preparation, provide a kind of bioavailability high, release fast, produce effects fast, toxic and side effects is little, and effective ingredient content is high, and taking dose is accurate, taking convenience, cheap, pollution-free and be convenient to the oral formulations promoting blood circulation and stopping pain drop pill of the pharmaceutical composition of going out to carry in production.
Promoting blood circulation and stopping pain drop pill involved in the present invention, its preparation method is determined through the lot of experiments screening, through most of medical material is extracted, and coordinates drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain promoting blood circulation and stopping pain drop pill involved in the present invention:
[preparation method]
1, prescription:
Radix Angelicae Sinensis 200-250g Radix Notoginseng 40-50g Olibanum (processed with vinegar) 40-50g Borneolum Syntheticum 10-15g Eupolyphaga Seu Steleophaga 100-120g Pyritum (calcined) 60-70g
Make 2000
Wherein the most practical prescription is: Radix Angelicae Sinensis 222g Radix Notoginseng 44g Olibanum (processed with vinegar) 44g Borneolum Syntheticum 11g Eupolyphaga Seu Steleophaga 111g Pyritum (calcined) 67g
Make 2000
2, specification: every 200mg
3, method for making:
3.1 the preparation of extract:
(1) get Radix Angelicae Sinensis, the Radix Notoginseng of recipe quantity, with 50% alcohol reflux three times, add for the first time 8 times of amount ethanol extractions 2 hours, second and third time adds respectively 6 times of amount ethanol extractions 1.5 hours, and extracting solution is standby;
(2) get the 95% alcohol reflux secondary for Olibanum of recipe quantity, add for the first time 8 times of amount ethanol extractions 2 hours, add for the second time 6 times of amount ethanol extractions 1.5 hours, extracting solution and said extracted liquid merge, and reclaim ethanol extremely without the alcohol flavor; Ethanol extract after recovery is standby;
(3) get Pyritum, Eupolyphaga Seu Steleophaga water extraction three times of recipe quantity, adding for the first time 10 times of water gagings extracts 2 hours, adding for the second time 8 times of water gagings extracts 1.5 hours, add for the third time 6 times of water gagings and extract 1 hour, the ethanol extract after extracting solution and above-mentioned recovery merges, concentrated, dry, be ground into dry powder, cross 100 mesh sieves, both obtained drug extract;
(4) get the Borneolum Syntheticum of recipe quantity, pulverize, cross 100 mesh sieves, both obtained the Borneolum Syntheticum fine powder.
3.2 drop pill preparation
(1) get said medicine extract and Borneolum Syntheticum fine powder, standby;
(2). substrate---select one or more the mixture in the pharmaceutically suitable carrier such as Polyethylene Glycol (1000～20000), s6, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
(3). the proportioning of drug extract and substrate---take g or kg as unit, by weight, drug extract: substrate=1: 1～1: 9;
(4). according to the given ratio of filling a prescription, accurately take drug extract and substrate, be placed in heating container and be heated to while stirring molten condition, add while stirring the Borneolum Syntheticum fine powder, airtight heating container, until obtain fused solution and/or emulsion and/or suspension, and static degassed 30-60 minute under 80-85 ℃ of keeping warm mode, wherein the more applicable static degassed time is 40-50 minute;
4. adopt commercially available pill dripping machine, and adjust the temperature control system of pill dripping machine, make the water dropper temperature of pill dripping machine remain on 85～90 ℃, the temperature of condensing agent is cooling and remain on 40～10 ℃;
5. when the temperature of condensing agent reaches respectively the said temperature state in pill dripping machine water dropper and condensation column, above-mentioned medicinal liquid is placed in to dripping in tank of pill dripping machine, selecting aperture is the 5-6mm water dropper, by water dropper, splashes in condensing agent;
6. will be shunk the drop pill taking-up of molding by the pill dripping machine outlet, remove the surface condensation agent, be drying to obtain.
7. described condensing agent can be any one of liquid paraffin or methyl-silicone oil or vegetable oil;
Beneficial effect
According to national drug standards WS
3the HUOXUE ZHIRONG JIAONANG that the formula provided in-091 (Z-81)-95 (Z) and pharmacopeia and extraction process are prepared from, a kind of have promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect: for the capsule class preparation of traumatic injury, congestion detumescence, through clinical verification for many years, steady quality, determined curative effect is the common drug preparation that clinical and family is used for the treatment of above disease.In addition, the peroral dosage forms such as tablet, powder in addition of this medicine listing now, but, above-mentioned oral formulations is due to reasons such as technologies of preparing, take and all exist that dissolve scattered time limit is long, dissolution is low, it is poor to absorb afterwards, liver sausage first pass effect and the problem such as bioavailability is lower, thereby affect the performance of drug effect, also directly affect therapeutic effect.
In addition, conventional peroral dosage form as tablet, capsule etc., due to the technique that granulation is arranged, therefore can produce larger 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 social general health level.
Promoting blood circulation and stopping pain drop pill involved in the present invention is compared with peroral dosage forms such as its tablet, capsule, powders, has following beneficial effect:
1. promoting blood circulation and stopping pain drop pill involved in the present invention, be on the preparation method basis of HUOXUE ZHIRONG JIAONANG and blood-activating pain stopping tablet, and the most of medicinal material extract effective ingredient in its prescription, be prepared from according to the preparation method of drops.
2. the present invention, to the most of medicinal material extract effective ingredient in prescription, compares with its capsule, tablet formulation, has increased the active drug content in the unit dose, has reduced taking dose, has improved curative effect of medication.
3. the present invention utilizes surfactant etc. for substrate; the dry powder that contains active constituents of medicine is made solid dispersion together; making medicine be molecule, colloid or microcrystalline state is scattered in substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine is had to wetting action, can make medicine leach into rapidly microgranule or solution, thereby make the dissolving of medicine and absorb to accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
4. the present invention compares with the administering mode of other traditional oral formulations, exist essential distinction, the drop pill prepared with solid dispersion technology, can adopt oral, all right sublingual administration, can make effective ingredient fully contact with mucomembranous surface, absorb by mucomembranous epithelial cell, directly enter blood circulation.Owing to without gastrointestinal tract and liver, directly entering blood circulation, effectively avoided first pass effect, also avoided gastrointestinal irritation, thus the characteristics such as it is rapid to have an onset, and bioavailability is high, and side effect is little, and medication is convenient.
5. promoting blood circulation and stopping pain drop pill involved in the present invention, contact and dissolve rapidly with saliva, and by buccal absorption, not only rapid-action, and the impact of not taken food, before or after meals all can be taken containing changing, and local application's onset is faster.
6. promoting blood circulation and stopping pain drop pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with the substrate of melting, splashes in not miscible condensed fluid and makes.Therefore, the stability of medicine is high, not facile hydrolysis, oxidation, and the operation be to carry out under liquid state, no dust pollution, be not subject to the impact of crystal formation, thereby guaranteed the quality of medicine, increased stability.
7. the production technology, the equipment that prepare drop pill are simple, easy to operate, and automaticity is high, and labor intensity is low, and production efficiency is high.Workshop, without dust, also is conducive to labor protection and environmental protection simultaneously.
8. the production cost for preparing drop pill is usually in 50% left and right of same other oral formulations of kind.
9. drug extract of the present invention can be for a long time and the mutual melting of substrate, and dispersion of medicine reaches the preparation condition of drop pill.
In sum, make promoting blood circulation and stopping pain drop pill involved in the present invention there is triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
The specific embodiment
Now with several groups of specific embodiments, with regard to the preparation method of promoting blood circulation and stopping pain drop pill of the present invention, be described further.
First group: the test of single-matrix
1. the preparation of drug extract and Borneolum Syntheticum fine powder:
According to 3.1 process in [preparation method], be prepared.
2. substrate: Polyethylene Glycol
(1000～20000), the pharmaceutically suitable carrier such as s6, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac.
3. proportioning: take g or kg as unit, by weight, drug extract: substrate=1: 1～1: 9.
4. the preparation of drop pill:
Be prepared according to 3.2 process in [preparation method], can make the promoting blood circulation and stopping pain drop pill.
[result of the test]
Test 1: for observe drug extract and different substrates when the proportioning of 1: 1 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, according to the ratio of 1: 1, by drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, the pharmaceutically suitable carrier such as s6, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain 17 pharmaceutical composition experiments that contain drug extract and different substrates, and obtain 17 groups of different experimental results in Table 1.
Test 2: for observe drug extract and different substrates when the proportioning of 1: 2 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, according to the ratio of 1: 2, by drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, the pharmaceutically suitable carrier such as s6, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain 17 pharmaceutical composition experiments that contain drug extract and different substrates, and obtain 17 groups of different experimental results in Table 2.
Test 3: for observe drug extract and different substrates when the proportioning of 1: 9 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, according to the ratio of 1: 9, by drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
9300, Polyethylene Glycol
10000, Polyethylene Glycol
20000, the pharmaceutically suitable carrier such as s6, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac matches, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain 17 pharmaceutical composition experiments that contain drug extract and different substrates, and obtain 17 groups of different experimental results in Table 3.
Second group: the test of mixed-matrix
The preparation of promoting blood circulation and stopping pain drop pill:
1. the preparation of medicinal substances extract and Borneolum Syntheticum fine powder:
According to 3.1 process in [preparation method], be prepared,
2. substrate: Polyethylene Glycol
4000, s6, betacyclodextrin, poloxamer, carboxymethyl starch sodium, pharmaceutically suitable carrier.
3. proportioning: take g or kg as unit, by weight, extract: mixed-matrix=1: 1～1: 9.
3.1 the ratio of mixed-matrix---s6: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10,
4. the preparation of drop pill:
Be prepared according to 3.2 process in [preparation method], can make the promoting blood circulation and stopping pain drop pill.
[result of the test]
Test 4: for observe drug extract and mixed-matrix when the proportioning of 1: 1 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 1 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 1, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 4.
Test 5: for observe drug extract and mixed-matrix when the proportioning of 1: 2 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 1 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 2, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 5.
Test 6: for observe drug extract and mixed-matrix when the proportioning of 1: 9 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 1 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 9, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 6.
Test 7: for observe drug extract and mixed-matrix when the proportioning of 1: 1 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 5 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 1, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 7.
Test 8: for observe drug extract and mixed-matrix when the proportioning of 1: 2 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 5 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 2, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 8.
Test 9: for observe drug extract and mixed-matrix when the proportioning of 1: 9 prepared promoting blood circulation and stopping pain drop pill in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 5 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 9, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 9.
Test 10: in order to observe promoting blood circulation and stopping pain drop pill that drug extract and mixed-matrix make when the proportioning of 1: 1 in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 10 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 1, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 10.
Test 11: in order to observe promoting blood circulation and stopping pain drop pill that drug extract and mixed-matrix make when the proportioning of 1: 2 in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 10 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 2, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results in Table 11.
Test 12: in order to observe promoting blood circulation and stopping pain drop pill that drug extract and mixed-matrix make when the proportioning of 1: 9 in qualitative difference, by s6, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin are usingd the ratio mix homogeneously of 1: 10 as mixed-matrix with Macrogol 4000 respectively, according to the ratio of 1: 9, by drug extract, the mixed-matrix different from 4 kinds mixed mutually and makes evenly again, add the Borneolum Syntheticum fine powder, adopt commercially available pill dripping machine, according to the step of stipulating in preparation method, be prepared, can obtain the pharmaceutical composition experiment that 4 drug extracts and mixed-matrix form, and obtain 4 groups of different experimental results 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 | 80 | ＜30 | ＜10 | + |
| Polyethylene Glycol 2000 | 50.0 | 82 | ＜30 | ＜10 | + |
| Polyethylene Glycol 4000 | 50.0 | 80 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 82 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 8000 | 50.0 | 79 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 9300 | 50.0 | 88 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 80 | ＜30 | ＜10 | ++ |
| S6 | 50.0 | 78 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 50.0 | 72 | ＜30 | ＜10 | + |
| Poloxamer | 50.0 | 79 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium | 50.0 | 73 | ＜30 | ＜10 | + |
| Sodium lauryl sulphate | 50.0 | 68 | ＞30 | ＜10 | ++ |
| Stearic acid | 50.0 | 55 | ＞30 | ＜10 | +++ |
| Sodium stearate | 50.0 | 54 | ＞30 | ＜10 | +++ |
| Glycerin gelatine | 50.0 | 55 | ＞30 | ＜10 | +++ |
| Lac | 50.0 | 52 | ＞30 | ＜10 | +++ |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 2)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 33.3 | 90 | ＜30 | ＜10 | + |
| Polyethylene Glycol 2000 | 33.3 | 94 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 4000 | 33.3 | 98 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 33.3 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 33.3 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 9300 | 33.3 | 94 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 10000 | 333 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 33.3 | 91 | ＜30 | ＜10 | ++ |
| S6 | 33.3 | 92 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 33.3 | 82 | ＜30 | ＞10 | ++ |
| Poloxamer | 333 | 89 | ＜30 | ＞10 | +++ |
| Carboxymethyl starch sodium | 33.3 | 80 | ＜30 | ＞10 | ++ |
| Sodium lauryl sulphate | 33.3 | 88 | ＜30 | ＜10 | ++ |
| Stearic acid | 33.3 | 87 | ＞30 | ＞10 | +++ |
| Sodium stearate | 333 | 86 | ＞30 | ＜10 | +++ |
| Glycerin gelatine | 33.3 | 93 | ＞30 | ＞10 | +++ |
| Lac | 33.3 | 93 | ＞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 | 70 | ＜30 | ＜10 | + |
| Polyethylene Glycol 2000 | 10.0 | 83 | ＜30 | ＜10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 94 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 8000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 9300 | 10.0 | 89 | ＜30 | ＞10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 93 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| S6 | 10.0 | 93 | ＜30 | ＜10 | ++ |
| Betacyclodextrin | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Poloxamer | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 83 | ＜30 | ＜10 | +++ |
| Stearic acid | 10.0 | 76 | ＞30 | ＜10 | +++ |
| Sodium stearate | 10.0 | 77 | ＞30 | ＜10 | +++ |
| Glycerin gelatine | 10.0 | 74 | ＞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 group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 2)
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 2)
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 2)
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
1. the result in table can be seen: in the test of single-matrix, when drug extract and substrate Polyethylene Glycol
4000ratio be 1: 2 o'clock, the index ideal such as its rounding rate, the ball method of double differences are different, dissolve scattered time limit, hardness.
2. the general effect of mixed-matrix is not as single-matrix.
3. the hardness method for expressing in subordinate list, adopt drop pill be placed on glass plate, press...withes one's finger it, observes its metamorphosis."+" means that flicking is out of shape, and " ++ " means the distortion of firmly pressing, and " +++" means by it indeformable.
Experiment: the dripping prodrug liquid status of different quiescent times
Experimental technique: by (3.1) and (3.2) preparation in preparation method, before dripping, medicinal liquid is sampled in the different time under keeping warm mode, observe the state of sample, the use that do not mix "-" means, the use that mixes "+" expression, and layering means with " * ".Being prepared as follows of sample:
Laboratory sample 1
According to the ratio of 1: 1, by raw material and Polyethylene Glycol
2000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 2
According to the ratio of 1: 1, by raw material and Polyethylene Glycol
4000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 3
According to the ratio of 1: 1, by raw material and Polyethylene Glycol
6000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 4
According to the ratio of 1: 2, by raw material and Polyethylene Glycol
2000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 5
According to the ratio of 1: 2, by raw material and Polyethylene Glycol
4000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 6
According to the ratio of 1: 2, by raw material and Polyethylene Glycol
6000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 7
According to the ratio of 1: 9, by raw material and Polyethylene Glycol
2000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 8
According to the ratio of 1: 9, by raw material and Polyethylene Glycol
4000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 9
According to the ratio of 1: 9, by raw material and Polyethylene Glycol
6000matching, be prepared according to the step of stipulating in preparation method, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 10
According to the ratio of 1: 1, by raw material and s6 and Polyethylene Glycol
2000(s6 wherein: Polyethylene Glycol
2000in the ratio mix homogeneously of 1: 1 as mixed-matrix) match, according to the step of stipulating in preparation method, being prepared, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 11
According to the ratio of 1: 1, by raw material and betacyclodextrin and Polyethylene Glycol
6000=1: 10 (betacyclodextrins wherein: Polyethylene Glycol
6000in the ratio mix homogeneously of 1: 10 as mixed-matrix) match, according to the step of stipulating in preparation method, being prepared, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 12
According to the ratio of 1: 1, by raw material and poloxamer and Polyethylene Glycol
4000(poloxamer wherein: Polyethylene Glycol
4000in the ratio mix homogeneously of 1: 10 as mixed-matrix) match, according to the step of stipulating in preparation method, being prepared, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Laboratory sample 13
According to the ratio of 1: 1, by raw material and carboxymethyl starch sodium and Polyethylene Glycol
20000(carboxymethyl starch sodium wherein: Polyethylene Glycol
20000in the ratio mix homogeneously of 1: 10 as mixed-matrix) match, according to the step of stipulating in preparation method, being prepared, is that 10min, 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min, 100min sample and observe sample state in quiescent time respectively.The results are shown in Table one.
Table one: raw material and the state of substrate mixture in different quiescent times
As can be seen from the above table, the epidemic situation comparison of the laboratory sample quiescent time of medicinal liquid when 30-70min is good, in order to guarantee medicinal liquid, reaches the best quiescent time of dripping dress state, is defined as 30-60min quiescent time, wherein be 40-50min more applicable quiescent time, and the medicinal liquid state is best.
Claims (3)
1. the preparation method with promoting blood circulation and stopping pain drop pill of promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect, by Radix Angelicae Sinensis 222g, Radix Notoginseng 44g, Olibanum (processed with vinegar) 44g, Borneolum Syntheticum 11g, Eupolyphaga Seu Steleophaga 111g, Pyritum (calcined) 67g is prepared from a certain proportion of pharmaceutically acceptable substrate composition after extracting processing, described medicinal substrate is selected Macrogol 4000, and the proportioning of drug extract and substrate is 1:2, and its preparation method is as follows:
(1) take Radix Angelicae Sinensis, Radix Notoginseng by proportioning, with 50% alcohol reflux three times, add for the first time 8 times of amount ethanol extractions 2 hours, second and third time adds respectively 6 times of amount ethanol extractions 1.5 hours, and extracting solution is standby;
(2) take Olibanum by proportioning, with 95% alcohol reflux secondary, add for the first time 8 times of amount ethanol extractions 2 hours, add for the second time 6 times of amount ethanol extractions 1.5 hours, extracting solution and above-mentioned reserve liquid merge, and reclaim ethanol extremely without the alcohol flavor; Ethanol extract after recovery is standby;
(3) take Pyritum, Eupolyphaga Seu Steleophaga by proportioning, with water extraction three times, add for the first time 10 times of water gagings and extract 2 hours, add for the second time 8 times of water gagings and extract 1.5 hours, add for the third time 6 times of water gagings and extract 1 hour, ethanol extract after extracting solution and above-mentioned recovery merges, concentrated, dry, pulverize into dry powder, cross 100 mesh sieves, obtain drug extract;
(4) take Borneolum Syntheticum by proportioning, pulverize, cross 100 mesh sieves, obtain the Borneolum Syntheticum fine powder;
(5) take drug extract and substrate by proportion speed, be placed in heating container, be heated to while stirring molten condition, add while stirring the Borneolum Syntheticum fine powder, airtight heating container, until obtain fused solution and/or emulsion and/or suspension, static degassed 30-60 minute under 80-85 ℃ of keeping warm mode;
(6) adopt commercially available pill dripping machine, and adjust the temperature control system of pill dripping machine, make the water dropper temperature of pill dripping machine remain on (85～90) ℃, the temperature of condensing agent is cooling and remain on (40～10) ℃;
(7) when in pill dripping machine water dropper and condensation column, the temperature of condensing agent reaches respectively the said temperature state, above-mentioned fused solution and/or emulsion and/or suspension, be placed in a tank of pill dripping machine, selecting aperture is the 5-6mm water dropper, by water dropper, splashes in condensing agent;
(8) will be shunk the drop pill taking-up of molding by the pill dripping machine outlet, remove the surface condensation agent, be drying to obtain.
2. a kind of preparation method with promoting blood circulation and stopping pain drop pill of promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect as claimed in claim 1, it is characterized in that: the more applicable static degassed time is 40-50 minute.
3. a kind of preparation method with promoting blood circulation and stopping pain drop pill of promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect as claimed in claim 1, it is characterized in that: described condensing agent can be any one of liquid paraffin or methyl-silicone oil or vegetable oil.
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