CN1730085A - Drop pill for treating hematuresis and process for preparing the same - Google Patents
Drop pill for treating hematuresis and process for preparing the same Download PDFInfo
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- CN1730085A CN1730085A CN 200510090140 CN200510090140A CN1730085A CN 1730085 A CN1730085 A CN 1730085A CN 200510090140 CN200510090140 CN 200510090140 CN 200510090140 A CN200510090140 A CN 200510090140A CN 1730085 A CN1730085 A CN 1730085A
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Abstract
The invention relates to a medicinal composition for treating hematuria, especially a dripping pill prepared from extract containing the active constituents of palmitic seeds, smilax China root, coix seed, and medicinal carrying agent as the base material. The dripping pills have the advantages of high biological availability, quick-speed medicine release, quick-speed effect, higher medicinal content, easy administering, low price, and no contamination in production.
Description
Technical field
The present invention relates to a kind of clearing away heat-damp and promoting diuresis that has, the cooling blood for hemostasis effect, the pharmaceutical composition that is used for the hematuria treatment that a variety of causes causes is a kind of drug composition oral preparation that feedstock production forms with the extract that contains pharmaceutically active ingredient in 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The hematuria capsule that the preparation method that provides among-the B-3204-98 is prepared from, it is a kind of clearing away heat-damp and promoting diuresis that has, the cooling blood for hemostasis effect, be used for acute and chronic pyelonephritis hematuria, glomerulonephritis hematuria, the oral tablet of the hematuria treatment that hematuria that urinary calculi and contusion of kidney cause and unknown cause cause, this tablet also can be used as the adjuvant therapy medicaments of urologic neoplasms, through clinical verification for many years, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Below be drug standard WS
3Prescription that provides among-the B-3204-98 and technology and brief description:
Prescription: Fructus trachycarpi 100g, Rhizoma Smilacis Chinensis 70g, Semen Coicis 50g
Method for making: above three flavors, get Fructus trachycarpi, Rhizoma Smilacis Chinensis, decoct with water secondary, each 3 hours, collecting decoction left standstill, filter, filtrate is concentrated into the clear paste that relative density is 1.15 (80 ℃), treats coldly, adds ethanol equivalent, shake up, left standstill 24 hours, and got supernatant, reclaim ethanol and be concentrated into the clear paste that relative density is 1.35 (50～55 ℃); Other gets Semen Coicis 16g, is ground into fine powder, and remaining Semen Coicis powder is broken into coarse powder, according to percolation (appendix IO) under fluid extract and the extractum item, make solution with 8 times of amounts of ethanol, flood and carry out percolation after 24 hours, the collection liquid of filtering, reclaim ethanol after, add 1.6 times calcium carbonate, stir evenly, add above-mentioned powder, extractum again, mixing, drying is ground into coarse powder, incapsulates, make 70, promptly.
Function cures mainly: clearing away heat-damp and promoting diuresis, cooling blood for hemostasis.Be used for acute and chronic pyelonephritis hematuria, the glomerulonephritis hematuria, the hematuria that hematuria that urinary calculi and contusion of kidney cause and unknown cause cause also can be used as the ancillary drug for the treatment of urologic neoplasms.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.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 to replenish the existing deficiency that is used for the treatment of the hematuria symptom oral drug preparation that a variety of causes causes, a kind of bioavailability height is provided, and has a quick release, produce effects fast, medicament contg height, taking convenience, cheap, and free of contamination aborning drop pill for treating hematuresis.Drop pill for treating hematuresis involved in the present invention is a raw material with the extract that contains pharmaceutically active ingredient in 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain drop pill for treating hematuresis involved in the present invention:
[preparation method]
1. raw material: the extract that contains pharmaceutically active ingredient in 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis;
2. substrate: 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, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
3. proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 10;
More practical proportion: drug extract: substrate=1: 1～1: 5;
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, TZDW-1 type drop pill machine as 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 in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, to contain fused solution and/or the emulsion and/or the suspension of drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, cooling is shunk and is shaped, promptly.
Annotate: described condensing agent is any one or the two or more mixture in liquid paraffin, methyl-silicone oil, the vegetable oil.
[preparation of drug extract]
Preparation method 1 described drug extract is made by following method: with g or kg is unit, according to the weight portion meter, gets 10 parts of Fructus trachycarpis, 7 portions of Rhizoma Smilacis Chinensiss, 5 parts of Semen Coiciss, more than three the flavor, get Fructus trachycarpi, Rhizoma Smilacis Chinensis, decoct with water secondary, each 3 hours, collecting decoction, leave standstill, filter, it is 1.1～1.2 clear paste that filtrate is concentrated into relative density, treat coldly, add ethanol equivalent, shake up, after leaving standstill 24 hours, get supernatant, standby behind the recovery ethanol; Other gets Semen Coicis powder and is broken into coarse powder, according to percolation under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and the extractum item, make solution with 8 times of amounts of ethanol, flood and carry out percolation after 24 hours, the collection liquid of filtering, reclaim ethanol after, add above-mentioned thick paste, be concentrated into relative density and be 1.3～1.4 thick paste, promptly get the drug extract thick paste; Or continue to make drying, and be ground into dry powder, promptly get drug extract dry powder.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The hematuria capsule that the preparation method that provides among-the B-3204-98 is prepared from, it is a kind of clearing away heat-damp and promoting diuresis that has, the cooling blood for hemostasis effect, be used for acute and chronic pyelonephritis hematuria, glomerulonephritis hematuria, the oral tablet of the hematuria treatment that hematuria that urinary calculi and contusion of kidney cause and unknown cause cause, this tablet also can be used as the adjuvant therapy medicaments of urologic neoplasms, through clinical verification for many years, determined curative effect is the common drug that clinical and family is used for the treatment of above-mentioned disease.
Owing to reasons such as technologies of preparing, the oral formulations of most drug, especially the oral formulations of Chinese medicine, exist all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.In addition, conventional peroral dosage form is as tablet, capsule, granule (electuary) etc., in preparation process because the technology of granulation is arranged, therefore can produce bigger dust pollution, can staff's health be worked the mischief to a certain extent, also can cause certain pollution simultaneously to environment.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.
Drop pill for treating hematuresis involved in the present invention is compared with the hematuria capsule has following beneficial effect:
1. drop pill for treating hematuresis involved in the present invention; utilize surfactant to be substrate; the extract of pharmaceutically active ingredient is made solid dispersion in containing 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine had wetting action; can make medicine molten microgranule or the solution of loosing into rapidly; thereby make the dissolving of medicine and absorb quickening; thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
2. drop pill for treating hematuresis involved in the present invention, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum, can not produce any residual harmful substance at gastric yet, thereby make that patient's medication is safer, also have medication convenience, characteristic of accurate simultaneously.
3. drop pill for treating hematuresis involved in the present invention mixes the extract that contains active constituents of medicine mutually with molten matrix, splashes in the not miscible condensed fluid and makes.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
4. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
5. the production cost of preparation drop pill is usually with about 50% of other oral formulations of kind, and compares with oral liquid, and the dosage of drop pill is accurate, thereby makes the patient take metering control easily.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of drop pill for treating hematuresis of the present invention.
[selection of prescription]
1. raw material: it is standby to make the drug extract dry powder that contains pharmaceutically active ingredient in 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis in advance according to [appendix];
2. single-matrix: be selected from Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, a kind of in the carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac;
3. composite substrate: with g or kg is unit, by weight, selects carriers such as Polyethylene Glycol, polyoxyethylene stearate 40 esters, carboxymethyl starch sodium, betacyclodextrin, tween to carry out composite test;
3.1 the combination of two kinds of different substrates: with g or kg is unit, by weight, gets 1 part polyoxyethylene stearate 40 esters or betacyclodextrin or carboxymethyl starch sodium or tween, makes up with 1～10 part Polyethylene Glycol, and Polyethylene Glycol wherein is meant Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture;
3.2 the combination of three kinds of different substrates: with g or kg is unit, by weight, get 1 part polyoxyethylene stearate 40 esters and 0.5～5 part carboxymethyl starch sodium (or betacyclodextrin or tween) and 1～10 part Polyethylene Glycol and make up, Polyethylene Glycol wherein is meant Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture;
3.3 the combination of four kinds of different substrates: with g or kg is unit, by weight, get 1 part polyoxyethylene stearate 40 esters and 0.5～5 part carboxymethyl starch sodium (or betacyclodextrin) and make up with 0.5～5 part tween and 1～10 part Polyethylene Glycol, Polyethylene Glycol wherein is a Polyethylene Glycol
1000～Polyethylene Glycol
20000In one or more mixture;
The proportioning of medicine material and substrate (with g or kg is unit, by weight):
Medicine material: substrate=1: 1～1: 9;
5. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the drop pill for treating hematuresis of different size.
Test the test of a single-matrix
Cooperating prepared drop pill for treating hematuresis in qualitative difference with different substrates in order to observe drug extract, is unit with g or kg, according to 1: 1,1: 3,1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, matrix phases such as span 40, polyoxyethylene stearate 40 esters, poloxamer, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac cooperate, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and different substrates, and obtain 3 groups of different experimental results and see Table 1～table 3.
Test the composite test of 2 two kinds of different substrates
Cooperate prepared drop pill for treating hematuresis in qualitative difference in order to observe drug extract with two kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) or betacyclodextrin (beta cyclodextrin) or carboxymethyl starch sodium or tween, respectively with 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 4～table 6.
Test the composite test of three or three kinds of different substrates
Cooperate prepared drop pill for treating hematuresis in qualitative difference in order to observe drug extract with three kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) respectively with 0.5 part, 3 parts, 5 parts beta cyclodextrin (or carboxymethyl starch sodium or tween), and 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 7～table 9.
Test the composite test of four or four kinds of different substrates
Cooperate prepared drop pill for treating hematuresis in qualitative difference in order to observe drug extract with four kinds of different substrates, with g or kg is unit, get 1 part polyoxyethylene stearate 40 esters (S40 ester) respectively with 0.5 part, 3 parts, 5 parts beta cyclodextrin (or carboxymethyl starch sodium), and 0.5 part, 3 parts, 5 parts tween, and 1 part, 5 parts, 10 parts Polyethylene Glycol makes up, again with drug extract and composite substrate respectively with 1: 1,1: 3,1: 9 ratio matches, be prepared according to the step of stipulating in the preparation method, can obtain the experiment of 3 groups of drug extracts and various combination substrate, and obtain 3 groups of different experimental results and see Table 10～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 | 64 | ＜30 | ＞10 | + |
| Polyethylene Glycol 4000 | 50.0 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 60 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 78 | ＜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 | 59 | ＞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 | 79 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 65 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 25.0 | 73 | ＞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: 10)
| 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 | 85 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 87 | ＜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 two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 50.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50.0 | 85 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50.0 | 86 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 50.0 | 80 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 50.0 | 84 | ＜30 | ＞10 | ++ |
The group practices of table 5 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 25.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 25.0 | 83 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25.0 | 85 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 25.0 | 77 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 25.0 | 80 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 25.0 | 80 | ＜30 | ＞10 | ++ |
The group practices of table 6 drug extract and two kinds of substrate
(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 |
| S40 ester: Polyethylene Glycol=1: 1 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 10.0 | 92 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 10.0 | 87 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10.0 | 84 | ＜30 | ＞10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Tween: Polyethylene Glycol=1: 1 | 10.0 | 79 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 5 | 10.0 | 82 | ＜30 | ＞10 | ++ |
| Tween: Polyethylene Glycol=1: 10 | 10.0 | 82 | ＜30 | ＞10 | ++ |
The group practices of table 7 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 50.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 88 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 50.0 | 90 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 50.0 | 90 | ＞30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | ++ |
The group practices of table 8 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 25.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 25.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 25.0 | 88 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 25.0 | 89 | ＞30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 25.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 25.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 9 drug extract and three kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 3: 5 | 10.0 | 90 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: Polyethylene Glycol=1: 5: 10 | 10.0 | 91 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 3: 5 | 10.0 | 88 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: Polyethylene Glycol=1: 5: 10 | 10.0 | 90 | ＞30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 0.5: 1 | 10.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 3: 5 | 10.0 | 86 | ＜30 | ＜10 | +++ |
| S40 ester: tween: Polyethylene Glycol=1: 5: 10 | 10.0 | 88 | ＜30 | ＜10 | +++ |
The group practices of table 10 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 50.0 | 83 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 85 | ＜30 | ＞10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 05: 05: 1 | 50.0 | 82 | ＞30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 50.0 | 83 | ＞30 | ＞10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 50.0 | 83 | ＞30 | ＞10 | ++ |
The group practices of table 11 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 05: 05: 1 | 25.0 | 84 | ＜30 | ＞10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 85 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 25.0 | 86 | ＞30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 25.0 | 86 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 25.0 | 88 | ＞30 | ＜10 | +++ |
The group practices of table 12 drug extract and four kinds of substrate
(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 |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 0.5: 0.5: 1 | 10.0 | 87 | ＜30 | ＜10 | ++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: beta cyclodextrin: tween: Polyethylene Glycol=1: 5: 5: 10 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 05: 05: 1 | 10.0 | 86 | ＞30 | ＜10 | ++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 3: 3: 5 | 10.0 | 87 | ＞30 | ＜10 | +++ |
| S40 ester: carboxymethyl starch sodium: tween: Polyethylene Glycol=1: 5: 5: 10 | 10.0 | 88 | ＞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 hardness etc. improves not obvious.
4. the general effect of composite interstitial substance is better than single-matrix.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (9)
1. the pharmaceutical composition drop pill for treating hematuresis with cooling blood for hemostasis effect is a raw material with the extract that contains pharmaceutically active ingredient in 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis, be prepared from pharmaceutically suitable carrier as substrate, wherein:
1.1 described substrate is selected from 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, above-mentioned carrier one or more mixture wherein;
1.2 with g or kg is unit, drug extract: substrate=1: 1～1: 9.
2. drop pill for treating hematuresis as claimed in claim 1, it is characterized in that described drug extract is made by following method: preparation method 1 described drug extract is made by following method: with g or kg is unit, according to the weight portion meter, gets 10 parts of Fructus trachycarpis, 7 portions of Rhizoma Smilacis Chinensiss, 5 parts of Semen Coiciss, more than three the flavor, get Fructus trachycarpi, Rhizoma Smilacis Chinensis, decoct with water secondary, each 3 hours, collecting decoction left standstill, filter, it is 1.1～1.2 clear paste that filtrate is concentrated into relative density, treats coldly, adds ethanol equivalent, shake up, after leaving standstill 24 hours, get supernatant, standby behind the recovery ethanol; Other gets Semen Coicis powder and is broken into coarse powder, according to percolation under 2000 editions Pharmacopoeia of People's Republic of China appendix IO fluid extracts and the extractum item, make solution with 8 times of amounts of ethanol, flood and carry out percolation after 24 hours, the collection liquid of filtering, reclaim ethanol after, add above-mentioned thick paste, be concentrated into relative density and be 1.3～1.4 thick paste, promptly get the drug extract thick paste; Or continue to make drying, and be ground into dry powder, promptly get drug extract dry powder.
3. drop pill for treating hematuresis as claimed in claim 1 is characterized in that: described substrate is the mixture of S40 ester or carboxymethyl starch sodium or beta cyclodextrin or tween and Polyethylene Glycol, and its mixed proportion is 1: 1～1: 10.
4. drop pill for treating hematuresis as claimed in claim 1 is characterized in that: described substrate is the mixture of S40 ester, beta cyclodextrin or carboxymethyl starch sodium or tween and Polyethylene Glycol, and its mixed proportion is 1: 0.5: 1～1: 5: 10.
5. drop pill for treating hematuresis as claimed in claim 1 is characterized in that: described substrate is the mixture of S40 ester, beta cyclodextrin or carboxymethyl starch sodium, tween and Polyethylene Glycol, and its mixed proportion is 1: 0.5: 0.5: 1～1: 5: 5: 10.
6. as claim 1 or 3 or 4 or 5 described any drop pill for treating hematuresis, it is characterized in that: the mixed proportion of described drug extract and substrate is 1: 1～1: 5.
7. as claim 3 or 4 or 5 described composite substrates, it is characterized in that: described Polyethylene Glycol is selected from Polyethylene Glycol
1000～Polyethylene Glycol
20000In any one or two or more mixture.
8. preparation method that is used for the described drop pill for treating hematuresis of claim 1 is characterized in that being made of following process:
8.1 raw material: the extract that contains pharmaceutically active ingredient in 3 flavors such as Fructus trachycarpi, Rhizoma Smilacis Chinensis, Semen Coicis;
8.2 substrate is selected from 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, above-mentioned carrier one or more mixture wherein;
8.3 proportioning: with g or kg is unit, by weight, and drug extract: substrate=1: 1～1: 9;
8.4, 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;
8.5 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 ℃;
8.6 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 fused solution and/or the emulsion and/or the suspension of drug extract and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent, cooling is shunk and is shaped, promptly.
9. preparation method as claimed in claim 8 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100901403A CN100382788C (en) | 2005-08-11 | 2005-08-11 | Drop pill for treating hematuresis and process for preparing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100901403A CN100382788C (en) | 2005-08-11 | 2005-08-11 | Drop pill for treating hematuresis and process for preparing the same |
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| Publication Number | Publication Date |
|---|---|
| CN1730085A true CN1730085A (en) | 2006-02-08 |
| CN100382788C CN100382788C (en) | 2008-04-23 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656095A (en) * | 2012-09-24 | 2014-03-26 | 张献奎 | Traditional Chinese medicinal preparation for specifically treating hematuria |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1284529C (en) * | 2004-11-02 | 2006-11-15 | 北京正大绿洲医药科技有限公司 | Compound gastrodia elata drop pills |
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2005
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103656095A (en) * | 2012-09-24 | 2014-03-26 | 张献奎 | Traditional Chinese medicinal preparation for specifically treating hematuria |
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