CN1679676A - Six-component saf-flower drops and preparation thereof - Google Patents
Six-component saf-flower drops and preparation thereof Download PDFInfo
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Abstract
A dripping pill of 6 drugs including saffron based on the oral liquid of 6 drugs including saffron for treating carbiopalmus, thoracalgia, palpitation, etc is disclosed. Its advantages are high release speed and quickly taking its high curative effect.
Description
Technical field
The present invention relates to a kind of invigorating kidney, promoting blood circulation effect that has, be used for the treatment of the thoracic obstruction that blood stasis due to renal deficiency causes, see chest pain, uncomfortable in chest, cardiopalmus, the pharmaceutical composition of diseases such as soreness of the waist and knees, be particularly related to based on the six-component saf-flower oral liquid, change a social system a kind of drug composition oral dropping pill formulation that forms through dosage form.
Background technology-ground changes state and feels concerned about 552 pages
The six-component saf-flower oral liquid that is prepared from according to the prescription that provides among the national drug standards WS-10723 (ZD-0723)-2002 and extraction process, it is a kind of invigorating kidney, promoting blood circulation effect that has, be used for the treatment of the thoracic obstruction that blood stasis due to renal deficiency causes, see chest pain, uncomfortable in chest, cardiopalmus, the Chinese medicine preparation of diseases such as soreness of the waist and knees, through clinical verification, steady quality, determined curative effect is the oral drug preparation commonly used that clinical and family is used for the treatment of above disease.
Below be prescription and the extraction process that provides among the drug standard WS-10723 (ZD-0723)-2002:
Prescription: Stigma Croci 2g, Fructus Lycii 100g, Herba Cistanches 100g, Cortex Moutan 50g, Ziziphora bungeana Juz. 50g, Radix Glycyrrhizae 25g, sucrose 100g, sodium benzoate 2g;
Method for making: above Six-element medical material, get Stigma Croci and soak (70～80 ℃) 6 times wet with 60% ethanol, each 30 minutes, merge impregnation liquid, left standstill 24 hours, filter, filtrate recycling ethanol, standby; Fructus Lycii is according to (appendix IO of Chinese Pharmacopoeia version in 2000, filters with the speed infiltration of per minute 3～5ml after 24 hours with 70% alcohol dipping, collects and permeates the liquid of filtering, and reclaims ethanol, and is standby under fluid extract and the extractum item; The Fructus Lycii medicinal residues decoct with water 2 hours, and decocting liquid is evaporated to the clear paste that relative density is 1.08～1.12 (60 ℃), add the ZTC1+1 natural clarifying agent, leave standstill 24 hours, filter filtrate for later use; Cortex Moutan, Ziziphora bungeana Juz. extract volatile oil with steam distillation, collect distillate, and be standby, and the aqueous solution after distillation device is in addition collected; Medicinal residues and Herba Cistanches, Radix Glycyrrhizae decoct with water secondary, and 2.5 hours for the first time, 1.5 hours for the second time, aqueous solution after decocting liquid and the distillation merges, and filters, and filtrate decompression is concentrated into the clear paste that relative density is 1.08～1.10 (60 ℃), put coldly, add ethanol and make water content alcohol amount reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol is with above-mentioned reserve liquid mixing, add sucrose and sodium benzoate, add water to ormal weight, stir evenly, filter, make 1000ml, promptly; Be explained as follows for said preparation in the appended six-component saf-flower oral liquid description:
Nomenclature of drug: six-component saf-flower oral liquid;
Main component: Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., Stigma Croci, Radix Glycyrrhizae;
Character: this product is the summary transparency liquid of rufous; Sweet in the mouth is refreshing refrigerant;
Function cures mainly:
Dimension doctor: strengthen mentality, vitality, the stomach warming that nourishes heart, kidney-tonifying health-care.Be used for the thoracic obstruction, uncomfortable in chest, angina pectoris, coronary heart disease etc.
The traditional Chinese medical science: invigorating kidney, promoting blood circulation.Be used for the thoracic obstruction that blood stasis due to renal deficiency causes, disease is seen chest pain, and is uncomfortable in chest, cardiopalmus, diseases such as soreness of the waist and knees.
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.Oral liquid exists simultaneously that medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes the high characteristics of inconvenience and production cost, also is not easy to go out to carry.Because of being subjected to the influence of existing injection technology of preparing restriction and Chinese medicinal ingredients complexity, Chinese medicine injection often is easy to generate acute allergic reaction or untoward reaction, it is big also to exist operation easier simultaneously, the patient suffering is big, make and the medical treatment cost height, transportation stores inconvenience, and patient economy burden is heavy, shortcomings such as unsuitable family use.Therefore, be necessary to seek the peroral dosage form of better Flos Carthami medicine to satisfy the needs that clinical treatment and family use.
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.Oral liquid also has medicament contg low, takes, carries inconvenience, the also difficult disadvantage such as accurate of taking dose.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.
Summary of the invention
Purpose of the present invention is that additional having now is used for the treatment of the thoracic obstruction that blood stasis due to renal deficiency causes, sees chest pain, uncomfortable in chest, cardiopalmus, the deficiency of the oral drug preparation of diseases such as soreness of the waist and knees, provide a kind of bioavailability height, release fast, produce effects fast, toxic and side effects is littler, and the medicament contg height, and taking dose is little, taking dose is accurate, taking convenience, cheap, and be convenient to the drug composition oral preparation six-component saf-flower drops of going out to carry.
Six-component saf-flower drops involved in the present invention determines that through a large amount of experiment sievings based on the extraction process of Chinese traditional patent formulation six-component saf-flower oral liquid, process is adjusted extracting section technology, and cooperates drop pill preparation technology to be prepared from.Be prepared by the following technical solutions, can obtain six-component saf-flower drops involved in the present invention:
[preparation method]
1. be unit with g or kg, according to the weight portion meter, get Stigma Croci, Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., the Radix Glycyrrhizae of some, it is standby to make drug extract thick paste or dry powder and volatile oil through extraction;
2. substrate---Polyethylene Glycol
(2000,4000,6000,8000,10000), 20000), one or more the mixture 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;
3. proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
4. according to 3. ratios that provide, accurately take by weighing drug extract and substrate, gradation is progressively inserted in the heating container, and heating while stirring is standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also remains on-5 ℃～40 ℃;
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, the volatile oil adding of extracting in Cortex Moutan, the Ziziphora bungeana Juz. is contained in the fused solution and/or emulsion and/or suspension of drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, insulation, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper, 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.
[a kind of preparation method of drug extract]
By weight, get the above Six-element medical material of certain umber, Stigma Croci soaks (70～80 ℃) with 60% ethanol 6 times wet, and each 30 minutes, merge impregnation liquid, left standstill 24 hours, filter, filtrate recycling ethanol, standby; Fructus Lycii after 24 hours, is filtered with the speed infiltration of per minute 3～5ml with 70% alcohol dipping according under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia version in 2000), collects and permeates the liquid of filtering, and reclaims ethanol, and is standby; The Fructus Lycii medicinal residues decoct with water 2 hours, and decocting liquid is evaporated to the clear paste that relative density is 1.08～1.12 (60 ℃), add the ZTC1+1 natural clarifying agent, leave standstill 24 hours, filter filtrate for later use; Cortex Moutan, Ziziphora bungeana Juz. extract volatile oil with steam distillation, collect distillate, and be standby, and the aqueous solution after distillation device is in addition collected; Medicinal residues and Herba Cistanches, Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, aqueous solution after decocting liquid and the distillation merges, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.08～1.10 (60 ℃), put coldly, add ethanol and make water content alcohol amount reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, with above-mentioned reserve liquid mixing cryoconcentration to the relative density that reduces pressure then be 1.3～1.4 thick paste, or with thick paste at 0.1Mpa, drying and crushing under 60 ℃ the condition promptly gets dry powder;
Given here is according to a kind of preparation method of extract comparatively commonly used, its processing step adjustment is formed again.Similarly method is a lot, is not limited to this a kind of method during actual enforcement.
Beneficial effect
The six-component saf-flower oral liquid that is prepared from according to the prescription that provides among the national drug standards WS-10723 (ZD-0723)-2002 and extraction process, it is a kind of invigorating kidney, promoting blood circulation effect that has, be used for the treatment of the thoracic obstruction that blood stasis due to renal deficiency causes, see chest pain, uncomfortable in chest, cardiopalmus, the Chinese medicine preparation of diseases such as soreness of the waist and knees, through clinical verification, steady quality, determined curative effect is the oral drug preparation commonly used that clinical and family is used for the treatment of above 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.Oral liquid exists simultaneously that medicament contg is low, and taking dose is big, and taking dose is inaccurate, takes the high characteristics of inconvenience and production cost, also is not easy to go out to carry.Because of being subjected to the influence of existing injection technology of preparing restriction and Chinese medicinal ingredients complexity, Chinese medicine injection often is easy to generate acute allergic reaction or untoward reaction, it is big also to exist operation easier simultaneously, the patient suffering is big, make and the medical treatment cost height, transportation stores inconvenience, and patient economy burden is heavy, shortcomings such as unsuitable family use.Therefore, be necessary to seek the peroral dosage form of better Flos Carthami medicine to satisfy the needs that clinical treatment and family use.
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.Oral liquid also has medicament contg low, takes, carries inconvenience, the also difficult disadvantage such as accurate of taking dose.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.
Six-component saf-flower drops involved in the present invention is compared with the six-component saf-flower oral liquid has following beneficial effect:
1. six-component saf-flower drops involved in the present invention; utilize surfactant to be substrate; with contain Stigma Croci; Fructus Lycii; Herba Cistanches; Cortex Moutan; Ziziphora bungeana Juz.; the extractum of Radix Glycyrrhizae active constituents of medicine or dry powder and volatile oil are made solid dispersion together; make medicine be molecule; colloid or microcrystalline state are 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, performance is efficient; quick-acting effects etc.
Compare with the administering mode of other peroral dosage form, exist essential distinction.Utilize the drop pill of solid dispersion technology preparation, can adopt oral and sublingual administration, effective ingredient is fully contacted with mucomembranous surface, absorb, directly enter blood circulation by mucomembranous epithelial cell.Because active constituents of medicine directly enters blood circulation without gastrointestinal tract and liver, has avoided first pass effect effectively, has also avoided gastrointestinal irritation, thereby it is rapid to make Saussurea involucrata drop pill involved in the present invention have an onset, the bioavailability height, side effect is little, characteristics such as medication convenience.
2. six-component saf-flower drops involved in the present invention contacts promptly with saliva and to dissolve rapidly, and is absorbed by oral mucosa, and is not only rapid-action, and the influence of not taken food, and promptly all can containing take after meal ante cibum.
3. six-component saf-flower drops 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.
In sum, make six-component saf-flower drops involved in the present invention have the advantage of 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, be described further with regard to the preparation method of six-component saf-flower drops of the present invention.
First group: the test of single-matrix
1. make earlier according to [a kind of preparation method of drug extract] one joint that to contain Stigma Croci, Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., Radix Glycyrrhizae extraction of active ingredients thing dry powder and volatile oil standby;
2. substrate: Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. be prepared according to [preparation method] 4～7 again, promptly can make the six-component saf-flower drops of various different sizes.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared six-component saf-flower drops in qualitative difference, according to 1: 1 ratio, with drug 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 drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared six-component saf-flower drops in qualitative difference, according to 1: 3 ratio, with drug 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 drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared six-component saf-flower drops in qualitative difference, according to 1: 9 ratio, with drug 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 drug extract and different substrates, and obtain 15 groups of different experimental results and see Table 3.
Second group: the test of mixed-matrix
1. make earlier according to [a kind of preparation method of drug extract] one joint contain Stigma Croci, structure Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., Radix Glycyrrhizae extraction of active ingredients thing dry powder is equipped with and volatile oil is standby;
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. (with g or kg is unit to proportioning, by weight)
3.1 the ratio of composite interstitial substance---polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10,
3.2 hybrid medicine extract: mixed-matrix weight and=1: 1～1: 9,
4. be prepared according to [preparation method] 4～7 again, promptly can make the six-component saf-flower drops of various different sizes.
[result of the test]
Test 4: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared six-component saf-flower drops in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared six-component saf-flower drops in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared six-component saf-flower drops in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared six-component saf-flower drops in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared six-component saf-flower drops in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared six-component saf-flower drops in qualitative difference, 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 drug extract is mixed mutually with 4 kinds of different mixed-matrixes 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 drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: for observe drug extract and mixed-matrix when 1: 1 the proportioning prepared six-component saf-flower drops in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, step according to the preparation method regulation is prepared, can get 4 pharmaceutical compositions that drug extract and mixed-matrix constituted experiments, and must 4 groups of different experimental results see Table 10.
Test 11: for observe drug extract and mixed-matrix when 1: 3 the proportioning prepared six-component saf-flower drops in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, step according to the preparation method regulation is prepared, can get 4 pharmaceutical compositions that drug extract and mixed-matrix constituted experiments, and must 4 groups of different experimental results see Table 11.
Test 12: for observe drug extract and mixed-matrix when 1: 9 the proportioning prepared six-component saf-flower drops in qualitative difference, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes again and make evenly, adopt homemade drop pill machine, step according to the preparation method regulation is prepared, can get 4 pharmaceutical compositions that drug extract and mixed-matrix constituted experiments, and must 4 groups of different experimental results see 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 2000 | ????50.0 | ????65 | ????＜30 | ????＞10 | + |
| Polyethylene Glycol 4000 | ????50.0 | ????77 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 6000 | ????50.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 8000 | ????50.0 | ????78 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 10000 | ????50.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 20000 | ????50.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin | ????50.0 | ????68 | ????＜30 | ????＞10 | + |
| Poloxamer | ????50.0 | ????73 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium | ????50.0 | ????72 | ????＜30 | ????＞10 | + |
| Sodium lauryl sulphate | ????50.0 | ????66 | ????＞30 | ????＞10 | ++ |
| Stearic acid | ????50.0 | ????56 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????50.0 | ????55 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????50.0 | ????57 | ????＞30 | ????＞10 | +++ |
| Lac | ????50.0 | ????55 | ????＞30 | ????＞10 | +++ |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 2000 | ????25.0 | ????80 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????25.0 | ????82 | ????＜30 | ????＜10 | ++ |
| Polyethylene Glycol 6000 | ????25.0 | ????88 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????25.0 | ????91 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????25.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????25.0 | ????92 | ????＜30 | ????＜10 | ++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????93 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????25.0 | ????81 | ????＜30 | ????＞10 | ++ |
| Poloxamer | ????25.0 | ????87 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????25.0 | ????82 | ????＜30 | ????＞10 | ++ |
| Sodium lauryl sulphate | ????25.0 | ????76 | ????＜30 | ????＞10 | ++ |
| Stearic acid | ????25.0 | ????70 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????25.0 | ????73 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????25.0 | ????69 | ????＞30 | ????＞10 | +++ |
| Lac | ????25.0 | ????71 | ????＞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 2000 | ????10.0 | ????85 | ????＜30 | ????＞10 | ++ |
| Polyethylene Glycol 4000 | ????10.0 | ????90 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 6000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 8000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 10000 | ????10.0 | ????93 | ????＜30 | ????＜10 | +++ |
| Polyethylene Glycol 20000 | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????89 | ????＜30 | ????＜10 | ++ |
| Betacyclodextrin | ????10.0 | ????88 | ????＜30 | ????＜10 | ++ |
| Poloxamer | ????10.0 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium | ????10.0 | ????82 | ????＜30 | ????＞10 | +++ |
| Sodium lauryl sulphate | ????10.0 | ????82 | ????＜30 | ????＞10 | +++ |
| Stearic acid | ????10.0 | ????79 | ????＞30 | ????＞10 | +++ |
| Sodium stearate | ????10.0 | ????80 | ????＞30 | ????＞10 | +++ |
| Glycerin gelatine | ????10.0 | ????76 | ????＞30 | ????＞10 | +++ |
| Lac | ????10.0 | ????75 | ????＞30 | ????＞10 | +++ |
The group practices of table 4 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????50 | ????85 | ????＜30 | ????＞10 | ++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????83 | ????＜30 | ????＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????79 | ????＜30 | ????＞10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????77 | ????＜30 | ????＞10 | + |
The group practices of table 5 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????84 | ????＜30 | ????＞10 | ++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????10 | ????88 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????86 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????83 | ????＜30 | ????＞10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????85 | ????＜30 | ????＞10 | +++ |
The group practices of table 7 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????50 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????50 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????50 | ????87 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????85 | ????＜30 | ????＞10 | ++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????89 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????88 | ????＜30 | ????＜10 | ++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????10 | ????93 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????89 | ????＜30 | ????＜10 | +++ |
The group practices of table 10 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????50 | ????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 | ????89 | ????＜30 | ????＞10 | +++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????92 | ????＜30 | ????＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????90 | ????＜30 | ????＜10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????87 | ????＜30 | ????＜10 | +++ |
The group practices of table 12 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????10 | ????93 | ????＜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 | ????93 | ????＜30 | ????＜10 | +++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, though the rounding rate, the ball method of double differences is different and index such as hardness has raising, and is 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 (7)
1. one kind is used for the treatment of the thoracic obstruction that blood stasis due to renal deficiency causes, see chest pain, uncomfortable in chest, cardiopalmus, the pharmaceutical composition six-component saf-flower drops of diseases such as soreness of the waist and knees is a raw material of Chinese medicine with Stigma Croci, Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., Radix Glycyrrhizae, after extraction obtains containing the drug extract of active constituents of medicine, be prepared from a certain proportion of pharmaceutically suitable carrier again, wherein;
1.1 with g or kg is unit, according to the weight portion meter, gets Stigma Croci, Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., the Radix Glycyrrhizae of some, makes drug extract thick paste or dry powder and volatile oil through extraction;
1.2 substrate---Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), one or more the mixture 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;
1.3 proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. six-component saf-flower drops 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 six-component saf-flower drops 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. six-component saf-flower drops as claimed in claim 1, it is characterized in that described drug extract thick paste or dry powder and volatile oil obtain by the following method: by weight, get the above Six-element medical material of certain umber, Stigma Croci soaks (70～80 ℃) with 60% ethanol 6 times wet, each 30 minutes, merges impregnation liquid, left standstill 24 hours, filter, filtrate recycling ethanol, standby; Fructus Lycii after 24 hours, is filtered with the speed infiltration of per minute 3～5ml with 70% alcohol dipping according under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia version in 2000), collects and permeates the liquid of filtering, and reclaims ethanol, and is standby; The Fructus Lycii medicinal residues decoct with water 2 hours, and decocting liquid is evaporated to the clear paste that relative density is 1.08～1.12 (60 ℃), add the ZTC1+1 natural clarifying agent, leave standstill 24 hours, filter filtrate for later use; Cortex Moutan, Ziziphora bungeana Juz. extract volatile oil with steam distillation, collect distillate, and be standby, and the aqueous solution after distillation device is in addition collected; Medicinal residues and Herba Cistanches, Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, aqueous solution after decocting liquid and the distillation merges, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.08～1.10 (60 ℃), put coldly, add ethanol and make water content alcohol amount reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, with above-mentioned reserve liquid mixing cryoconcentration to the relative density that reduces pressure then be 1.3～1.4 thick paste, or with thick paste at 0.1Mpa, drying and crushing under 60 ℃ the condition promptly gets dry powder.
5. the preparation method of a six-component saf-flower drops is characterized in that being made of following process:
5.1 with g or kg is unit, according to the weight portion meter, gets Stigma Croci, Fructus Lycii, Herba Cistanches, Cortex Moutan, Ziziphora bungeana Juz., the Radix Glycyrrhizae of some, it is standby to make drug extract thick paste or dry powder and volatile oil through conventional extraction process;
5.2 substrate---Polyethylene Glycol
(2000,4000,6000,8000,10000,20000), one or more the mixture 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;
5.3 proportioning---with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
5.4, 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 drug extract and substrate and/or emulsion and/or suspension;
5.5 adopt homemade or general drop pill machine, and adjust the temperature control system of 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-5 ℃～40 ℃;
5.6 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, the volatile oil adding of extracting in Cortex Moutan, the Ziziphora bungeana Juz. is contained in the fused solution and/or emulsion and/or suspension of drug extract and substrate, under the temperature conditions close, make evenly through fully stirring with the water dropper temperature, insulation, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper and shrink shaping promptly.
6. as the preparation method of six-component saf-flower drops as described in the claim 5, it is characterized in that method 5.1 described drug extract thick pastes or dry powder and volatile oil obtain by the following method: by weight, get the above Six-element medical material of certain umber, Stigma Croci soaks (70～80 ℃) with 60% ethanol 6 times wet, each 30 minutes, merges impregnation liquid, left standstill 24 hours, filter, filtrate recycling ethanol, standby; Fructus Lycii after 24 hours, is filtered with the speed infiltration of per minute 3～5ml with 70% alcohol dipping according under fluid extract and the extractum item (appendix IO of Chinese Pharmacopoeia version in 2000), collects and permeates the liquid of filtering, and reclaims ethanol, and is standby; The Fructus Lycii medicinal residues decoct with water 2 hours, and decocting liquid is evaporated to the clear paste that relative density is 1.08～1.12 (60 ℃), add the ZTC1+1 natural clarifying agent, leave standstill 24 hours, filter filtrate for later use; Cortex Moutan, Ziziphora bungeana Juz. extract volatile oil with steam distillation, collect distillate, and be standby, and the aqueous solution after distillation device is in addition collected; Medicinal residues and Herba Cistanches, Radix Glycyrrhizae decoct with water secondary, 2.5 hours for the first time, 1.5 hours for the second time, aqueous solution after decocting liquid and the distillation merges, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.08～1.10 (60 ℃), put coldly, add ethanol and make water content alcohol amount reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, with above-mentioned reserve liquid mixing cryoconcentration to the relative density that reduces pressure then be 1.3～1.4 thick paste, or with thick paste at 0.1Mpa, drying and crushing under 60 ℃ the condition promptly gets dry powder.
7. as the preparation method of six-component saf-flower drops as described in the claim 5, it is characterized in that: method 5.6 described condensing agents are methyl-silicone oils or/and liquid paraffin or/and vegetable oil.
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|---|---|---|---|
| CN 200510002886 CN1679676A (en) | 2005-01-28 | 2005-01-28 | Six-component saf-flower drops and preparation thereof |
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|---|---|---|---|
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048813A (en) * | 2011-01-10 | 2011-05-11 | 新疆维吾尔自治区药物研究所 | Ziziphora bungeana dripping pills, production method thereof and application of dripping pills as cardiovascular medicament |
| CN103907810A (en) * | 2013-01-07 | 2014-07-09 | 阙锋 | Five-red-component preparation and preparation method thereof |
| CN105879432A (en) * | 2015-01-18 | 2016-08-24 | 广东省中医院 | Method for clarifying Chinese herbal preparation for treating psoriasis |
| CN113456584A (en) * | 2021-07-12 | 2021-10-01 | 国药集团新疆制药有限公司 | Preparation method of six-ingredient saffron oral liquid |
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2005
- 2005-01-28 CN CN 200510002886 patent/CN1679676A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048813A (en) * | 2011-01-10 | 2011-05-11 | 新疆维吾尔自治区药物研究所 | Ziziphora bungeana dripping pills, production method thereof and application of dripping pills as cardiovascular medicament |
| CN102048813B (en) * | 2011-01-10 | 2012-07-11 | 新疆维吾尔自治区药物研究所 | Ziziphora bungeana dripping pills, production method thereof and application of dripping pills as cardiovascular medicament |
| CN103907810A (en) * | 2013-01-07 | 2014-07-09 | 阙锋 | Five-red-component preparation and preparation method thereof |
| CN105879432A (en) * | 2015-01-18 | 2016-08-24 | 广东省中医院 | Method for clarifying Chinese herbal preparation for treating psoriasis |
| CN113456584A (en) * | 2021-07-12 | 2021-10-01 | 国药集团新疆制药有限公司 | Preparation method of six-ingredient saffron oral liquid |
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