CN1709420A - Motherwort dropping pill and its preparing method - Google Patents
Motherwort dropping pill and its preparing method Download PDFInfo
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- CN1709420A CN1709420A CN 200510076628 CN200510076628A CN1709420A CN 1709420 A CN1709420 A CN 1709420A CN 200510076628 CN200510076628 CN 200510076628 CN 200510076628 A CN200510076628 A CN 200510076628A CN 1709420 A CN1709420 A CN 1709420A
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Abstract
The present invention discloses a Chinese medicine composition with the action of contracting uterine for regulating menstruation and arresting hemorrhage. Said medicine composition can be made into oral Yimucao dripping pills, and is made up by using Chinese medicinal material motherwort as raw material and medicinal carrier as matrix through a certain preparation proves.
Description
Technical field
The present invention relates to a kind of have shrink the uterus effect, be used for the pharmaceutical composition of gynecological's blood-arresting catamenia-regulating, be raw material particularly with the Chinese medicine Herba Leonuri, a kind of drug composition oral preparation that is prepared from pharmaceutically suitable carrier as substrate.
Background technology
According to the drug standard WS promulgated by the ministries or commissions of the Central Government of country
3The Herba Leonuri injection that prescription that provides among-the B-3969-98 and extraction process are prepared from, be a kind of pure Chinese medicine that is used for gynecological's blood-arresting catamenia-regulating, through clinical verification for many years, steady quality, determined curative effect is the common drug that is used for the treatment of above-mentioned disease clinically with family.
Below be drug standard WS
3Prescription that provides among-the B-3969-98 and extraction process:
Method for making: get Herba Leonuri and decoct with water three times, collecting decoction filters, it is 1.36～1.38 that filtrate decompression is concentrated into relative density, and thin up to water content is about 35%, respectively with 88%～95% ethanol extraction three times, leave standstill, filter, reclaim ethanol, it is colourless to solution to decolour with active carbon (consumption is 0.01%～0.5%), adds 1% benzyl alcohol, adds the injection water and makes into and contain stachydrine 20mg among the 1ml, take off charcoal, fine straining, embedding, sterilization, promptly.
Function cures mainly: uterotonic.Be used for blood-arresting catamenia-regulating.
Owing to be 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.
In addition, owing to reasons such as technologies of preparing, the oral formulations of most drug exists 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.Simultaneously, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the complex manufacturing of conventional oral formulations, production cost is higher, thereby patient's drug cost is also improved thereupon, is unfavorable for improving the ability of seeking medical advice of extensive patients, also is unfavorable for improving the general health level of society.Therefore, be necessary to seek the peroral dosage form of better Flos Carthami medicine to satisfy the needs that clinical treatment and family use.
Summary of the invention
Purpose of the present invention is to replenish the existing deficiency that is used for the treatment of aforementioned disease oral drug preparation, and a kind of bioavailability height is provided, release fast, quick produce effects, toxic and side effects is little, manufacturing and medical treatment cost are low, low price, the oral motherwort dropping pill that is suitable for family to use.Motherwort dropping pill involved in the present invention is a raw material with the Chinese medicine Herba Leonuri, is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain motherwort dropping pill involved in the present invention.
[preparation method]
1. the preparation of drug extract: with g or kg is unit, gets 1 part of Herba Leonuri, decocts with water three times, collecting decoction filters, and it is 1.36～1.38 that filtrate decompression is concentrated into relative density, thin up to water content is about 35%, respectively with 88%～95% ethanol extraction three times, and merging filtrate, leave standstill, filter, reclaim ethanol, to be concentrated into relative density under the 0.1Mpa condition be 1.36～1.38 thick paste being decompressed to, or continue to make drying under the same conditions, be ground into dry powder, promptly;
2. substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. according to the given ratio of prescription, accurately take by weighing drug extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
5. adopt homemade or general drop pill machine (as the TZDW-1 type drop pill machine of Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing's production), and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on (50～90) ℃, the temperature cooling of condensing agent also remains on (40～-5) ℃;
6. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, fused solution and/or the emulsion and/or the suspension that will contain drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, condensing agent can be any one in liquid paraffin, methyl-silicone oil, the vegetable oil;
7. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
[beneficial effect]
According to the drug standard WS promulgated by the ministries or commissions of the Central Government of country
3The Herba Leonuri injection that prescription that provides among-the B-3969-98 and extraction process are prepared from, be a kind of pure Chinese medicine that is used for gynecological's blood-arresting catamenia-regulating, through clinical verification for many years, steady quality, determined curative effect is the common drug that is used for the treatment of above-mentioned disease clinically with family.
Owing to be 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.
The oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form as tablet, capsule etc., because the technology of granulation is arranged, therefore can produce bigger dust pollution in preparation process, can staff's health be worked the mischief to a certain extent, also can cause certain pollution to environment simultaneously.Moreover, the dirt production. art complexity 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.
Motherwort dropping pill involved in the present invention is compared with the Herba Leonuri injection, and following beneficial effect is arranged:
1. motherwort dropping pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with extractum that contains the Herba Leonuri active constituents of medicine or dry powder; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases, and substrate is hydrophilic, and medicine is had wetting action; can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with the administering mode of traditional oral formulations, exist essential distinction.Drop pill with the solid dispersion technology preparation can adopt oral and sublingual administration, and effective ingredient is fully contacted with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Owing to directly enter blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to have an onset, bioavailability height, characteristics such as side effect is little, and medication is convenient.
Chinese patent medicine injection series products is because of producing and basic research seriously lags behind, and the standardization issue of medicine never is resolved.The Chinese crude drug raw material itself is exactly a miscellaneous complex of chemical constituent, also there is not a kind of effective quality control method can reflect the quality and the difference thereof of product comprehensively, comprehensively, truly so far, and can carry out the quality control of production overall process effectively, cause the drug quality instability.The untoward reaction of Chinese medicine at present happens occasionally, but can't fundamentally understand fully to be due to which kind of composition, therefore can not in time make and deal with the aftermath of remedial measure targetedly, stay hidden danger for the hospital clinical medication.Injection manufacturing in addition, cost of transportation height use inconvenience, and this had both increased the weight of patient economy burden, have increased the misery of using again.Compare with Flos Carthami injection, the oral administration dripping pill agent has avoided medicine directly into blood, can reduce acute toxic and side effects and anaphylactoid generation effectively, and is safe and convenient to use, and effect is lasting, applied range; Manufacturing and medical treatment cost reduce greatly simultaneously, have effectively alleviated patient's financial burden, and have stored, transport, carry and use all more convenient.
2. motherwort dropping pill 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. motherwort dropping pill involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the dirt of preparation drop pill produces cost usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of motherwort dropping pill of the present invention.
[first group: the test of single-matrix]
1. raw material: it is standby to make the dry powder that contains Chinese medicine Herba Leonuri active pharmaceutical ingredient in advance according to preparation method 1;
2. substrate: Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the motherwort dropping pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared motherwort dropping pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, 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, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 1.
Test 2: for observe drug extract and different substrates when 1: 3 the proportioning prepared motherwort dropping pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, 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, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 2.
Test 3: for observe drug extract and different substrates when 1: 9 the proportioning prepared motherwort dropping pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, 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, be prepared according to the step of stipulating in the preparation method, can obtain 13 pharmaceutical compositions experiments that contain drug extract and different substrates, and obtain 13 groups of different experimental results and see Table 3.
[second group: the test of mixed-matrix]
1. raw material: it is standby to make the dry powder that contains Chinese medicine Herba Leonuri active pharmaceutical ingredient in advance according to preparation method 1;
2. substrate:
2.1 Polyethylene Glycol---English name Macrogol,
2.2 polyoxyethylene stearate 40 esters---English name Polyoxyl (40) Stearate,
Molecular formula is with C
17H
35COO (CH
2CH
2O)
nH represents that n is about 40,
2.3 poloxamer---English name Poloxamer, polyoxyethylene poly-oxygen propylene aether,
Molecular formula HO (C
2H
4O)
a(C
3H
6O)
b(C
2H
4O)
cH,
The sodium salt of the starch carboxymethyl ester that 2.4 carboxymethyl starch sodium---English name Carboxymethylstach Sodium, starch generates with the monoxone effect under alkali condition,
2.5 betacyclodextrin---English name Betacyclodextrin, molecular formula C
6H
10O
5, this product is that ring dextrin glucosyl transferase acts on 7 glucoses that starch generates with α-1, the bonded cyclic oligosaccharide of 4-glycosidic bond;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the motherwort dropping pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 4.
Test 5: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 5.
Test 6: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 1 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 6.
Test 7: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 1 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 7.
Test 8: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 3 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 8.
Test 9: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 5 mixed evenly as mixed-matrix, according to 1: 9 ratio different with the 4 kinds respectively mixing matrix phases of drug extract are mixed again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 9.
Test 10: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 1 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 1 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 3 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 3 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and see Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix prepared motherwort dropping pill when 1: 9 the proportioning, with polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, 4 kinds of carriers such as betacyclodextrin respectively with Polyethylene Glycol with 1: 10 mixed evenly as mixed-matrix, according to 1: 9 ratio drug extract is mixed mutually with 4 kinds of different mixed-matrixes respectively again and make evenly, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 4 pharmaceutical compositions that drug extract and mixed-matrix constituted, and obtain 4 groups of different experimental results and 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 1000 | ????50.0 | ????62 | ????＜30 | ????＞10 | ??+ |
| Polyethylene Glycol 4000 | ????50.0 | ????80 | ????＜30 | ????＞10 | ??++ |
| Polyethylene Glycol 6000 | ????50.0 | ????81 | ????＜30 | ????＞10 | ??++ |
| Polyethylene Glycol 10000 | ????50.0 | ????83 | ????＜30 | ????＞10 | ??++ |
| Polyethylene Glycol 20000 | ????50.0 | ????83 | ????＜30 | ????＞10 | ??++ |
| Span 40 | ????50.0 | ????62 | ????＜30 | ????＞10 | ??++ |
| Polyoxyethylene stearate 40 esters | ????50.0 | ????80 | ????＜30 | ????＞10 | ??+ |
| Poloxamer | ????50.0 | ????82 | ????＜30 | ????＞10 | ??+ |
| Sodium lauryl sulphate | ????50.0 | ????60 | ????＞30 | ????＞10 | ??++ |
| Stearic acid | ????50.0 | ????61 | ????＞30 | ????＞10 | ??++ |
| Sodium stearate | ????50.0 | ????61 | ????＞30 | ????＞10 | ??+ |
| Glycerin gelatine | ????50.0 | ????60 | ????＞30 | ????＞10 | ??+ |
| Lac | ????50.0 | ????59 | ????＞30 | ????＞10 | ??+ |
The group practices of table 2 drug extract and single-matrix
(drug extract: substrate=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | ????25.0 | ????76 | ????＜30 | ????＞10 | ?++ |
| Polyethylene Glycol 4000 | ????25.0 | ????87 | ????＜30 | ????＜10 | ?+++ |
| Polyethylene Glycol 6000 | ????25.0 | ????88 | ????＜30 | ????＜10 | ?+++ |
| Polyethylene Glycol 10000 | ????25.0 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Polyethylene Glycol 20000 | ????25.0 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Span 40 | ????25.0 | ????62 | ????＜30 | ????＜10 | ?+++ |
| Polyoxyethylene stearate 40 esters | ????25.0 | ????84 | ????＜30 | ????＞10 | ?++ |
| Poloxamer | ????25.0 | ????86 | ????＜30 | ????＜10 | ?+++ |
| Sodium lauryl sulphate | ????25.0 | ????74 | ????＞30 | ????＞10 | ?+++ |
| Stearic acid | ????25.0 | ????73 | ????＞30 | ????＞10 | ?+++ |
| Sodium stearate | ????25.0 | ????72 | ????＞30 | ????＞10 | ?+++ |
| Glycerin gelatine | ????25.0 | ????71 | ????＞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 1000 | ????10.0 | ????82 | ????＜30 | ????＞10 | ?++ |
| Polyethylene Glycol 4000 | ????10.0 | ????88 | ????＜30 | ????＜10 | ?+++ |
| Polyethylene Glycol 6000 | ????10.0 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Polyethylene Glycol 10000 | ????10.0 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Polyethylene Glycol 20000 | ????10.0 | ????90 | ????＜30 | ????＜10 | ?+++ |
| Span 40 | ????10.0 | ????66 | ????＜30 | ????＜10 | ?+++ |
| Polyoxyethylene stearate 40 esters | ????10.0 | ????84 | ????＜30 | ????＜10 | ?++ |
| Poloxamer | ????10.0 | ????87 | ????＜30 | ????＜10 | ?+++ |
| Sodium lauryl sulphate | ????10.0 | ????75 | ????＞30 | ????＞10 | ?+++ |
| Stearic acid | ????10.0 | ????74 | ????＞30 | ????＞10 | ?+++ |
| Sodium stearate | ????10.0 | ????73 | ????＞30 | ????＞10 | ?+++ |
| Glycerin gelatine | ????10.0 | ????73 | ????＞30 | ????＞10 | ?+++ |
| Lac | ????10.0 | ????72 | ????＞30 | ????＞10 | ?++ |
The group practices of table 4 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 | ????84 | ????＜30 | ????＞10 | ?++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????50 | ????83 | ????＜30 | ????＞10 | ?++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????50 | ????82 | ????＜30 | ????＞10 | ?++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????50 | ????81 | ????＜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 | ????92 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????25 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????25 | ????87 | ????＜30 | ????＞10 | ?++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????25 | ????88 | ????＜30 | ????＞10 | ?++ |
The group practices of table 6 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 1 | ????10 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 1 | ????10 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | ????10 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | ????10 | ????90 | ????＜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 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????50 | ????90 | ????＜30 | ????＜10 | ?++ |
The group practices of table 8 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????25 | ????92 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????25 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????25 | ????90 | ????＜30 | ????＜10 | ?+++ |
The group practices of table 9 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 9)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 5 | ????10 | ????92 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | ????10 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | ????10 | ????92 | ????＜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 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????50 | ????88 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????50 | ????91 | ????＜30 | ????＞10 | ?+++ |
The group practices of table 11 drug extract and mixed-matrix
(drug extract: mixed-matrix=1: 3)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyoxyethylene stearate 40 esters: Polyethylene Glycol=1: 10 | ????25 | ????92 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????25 | ????90 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????25 | ????89 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????25 | ????88 | ????＜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 | ????90 | ????＜30 | ????＜10 | ?+++ |
| Poloxamer: Polyethylene Glycol=1: 10 | ????10 | ????91 | ????＜30 | ????＜10 | ?+++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | ????10 | ????92 | ????＜30 | ????＜10 | ?+++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | ????10 | ????92 | ????＜30 | ????＜10 | ?+++ |
1. can be seen by the result in the table: when the ratio of drug extract and substrate was 1: 1, its rounding rate, the ball method of double differences was different and index such as hardness is all undesirable, and dissolve scattered time limit influenced not obvious.
2. when the ratio of drug extract and substrate is 1: 3, the rounding rate, the ball method of double differences is different and index such as hardness slightly all begins to enter preferable state.
3. when the ratio of drug extract and substrate is 1: 9, the rounding rate, the ball method of double differences is different and index such as hardness improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly becomes
Claims (5)
1. a pharmaceutical composition motherwort dropping pill that is used for gynecological's blood-arresting catamenia-regulating is a raw material with the Chinese medicine Herba Leonuri, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 the preparation of drug extract: with g or kg is unit, gets 1 part of Herba Leonuri, decocts with water three times, collecting decoction filters, and it is 1.36～1.38 that filtrate decompression is concentrated into relative density, thin up to water content is about 35%, respectively with 88%～95% ethanol extraction three times, and merging filtrate, leave standstill, filter, reclaim ethanol, to be concentrated into relative density under the 0.1Mpa condition be 1.36～1.38 thick paste being decompressed to, or continue to make drying under the same conditions, be ground into dry powder, promptly;
1.2 substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
1.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9.
2. motherwort dropping pill as claimed in claim 1 is characterized in that: described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or Polyethylene Glycol and poloxamer or Polyethylene Glycol and carboxymethyl starch sodium or Polyethylene Glycol and betacyclodextrin; With g or kg is unit, and by weight, its mixed proportion is polyoxyethylene stearate 40 esters: Polyethylene Glycol or poloxamer: Polyethylene Glycol or carboxymethyl starch sodium: Polyethylene Glycol or betacyclodextrin: Polyethylene Glycol=1: 1～1: 10.
3. any motherwort dropping pill as claimed in claim 1 or 2 is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
4. the preparation method of a motherwort dropping pill is characterized in that being made of following process:
4.1 the preparation of drug extract: with g or kg is unit, gets 1 part of Herba Leonuri, decocts with water three times, collecting decoction filters, and it is 1.36～1.38 that filtrate decompression is concentrated into relative density, thin up to water content is about 35%, respectively with 88%～95% ethanol extraction three times, and merging filtrate, leave standstill, filter, reclaim ethanol, to be concentrated into relative density under the 0.1Mpa condition be 1.36～1.38 thick paste being decompressed to, or continue to make drying under the same conditions, be ground into dry powder, promptly;
4.2 substrate: the mixture of one or more in pharmaceutically suitable carrier such as polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, polyoxyethylene stearate 40 esters, betacyclodextrin, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
4.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
4.4, accurately take by weighing drug extract and substrate according to the given ratio of prescription, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing drug extract and substrate and/or emulsion and/or suspension;
4.5 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 40 ℃～-5 ℃;
4.6 when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, to contain the fused solution of drug extract and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
5. as the preparation method of motherwort dropping pill as described in the claim 4, it is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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|---|---|---|---|
| CNB2005100766280A CN1315472C (en) | 2005-06-13 | 2005-06-13 | Motherwort dropping pill and its preparing method |
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|---|---|---|---|
| CNB2005100766280A CN1315472C (en) | 2005-06-13 | 2005-06-13 | Motherwort dropping pill and its preparing method |
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|---|---|---|---|---|
| CN113030359A (en) * | 2021-01-28 | 2021-06-25 | 成都第一制药有限公司 | Detection method for various index components in motherwort injection and quality control method of motherwort injection |
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| CN113030359A (en) * | 2021-01-28 | 2021-06-25 | 成都第一制药有限公司 | Detection method for various index components in motherwort injection and quality control method of motherwort injection |
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