CN100375616C - Bone strengthening dripping pills with Premena fulva craib as raw material and method for preparing the same - Google Patents
Bone strengthening dripping pills with Premena fulva craib as raw material and method for preparing the same Download PDFInfo
- Publication number
- CN100375616C CN100375616C CNB200510087059XA CN200510087059A CN100375616C CN 100375616 C CN100375616 C CN 100375616C CN B200510087059X A CNB200510087059X A CN B200510087059XA CN 200510087059 A CN200510087059 A CN 200510087059A CN 100375616 C CN100375616 C CN 100375616C
- Authority
- CN
- China
- Prior art keywords
- polyethylene glycol
- substrate
- mixed
- drop pill
- drug extract
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a medical composition which has functions of activating blood circulation, removing stasis, strengthening the muscles and bones, expelling pathogenic wind and alleviating pain and is used for curing diseases of vertebra hyperostosis, rheumatic arteritis arthralgia, etc. The present invention aims to replenish the insufficiency of the existing oral medicine preparation for curing diseases and provide a bone strengthening dripping pill which has the advantages of high biologic utilization rate, fast dilution of medicine, fast effect, high medicinal content, accurate measurement for taking, low cost, no acute allergic reaction or adverse effect, convenient transportation and portability. The bone strengthening dripping pill of the present invention uses premena fulva craib as a raw material which is together prepared with a medicinal carrier which serves as a stroma.
Description
Technical field
The present invention relates to a kind of promoting blood circulation to remove blood stasis that has, strengthening the tendons and bones, the wind dispelling analgesic effect is used for vertebrae hyperosteogeny disease, and the pharmaceutical composition of disease treatments such as rheumatic arthralgia particularly is a kind of drug composition oral preparation that feedstock production forms with the ZHANGU.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The JIANGU ZHUSHEYE that the preparation method that provides among-the B-2768-97 is prepared from is a kind of promoting blood circulation to remove blood stasis that has, strengthening the tendons and bones, the wind dispelling analgesic effect, be used for vertebrae hyperosteogeny disease, the pure Chinese medicine injection of disease treatments such as rheumatic arthralgia, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Below be drug standard WS
3Prescription that provides among-the B-2768-97 and technology and brief description:
Prescription: ZHANGU (stem)
Method for making: get ZHANGU (stem) sheet 2500g, clean, with 20% soak with ethanol more than 72 hours, get supernatant, filter, filtrate concentrates 8 times of inventory most, add ethanol and make and contain alcohol amount and reach 80%, stir, placed 12 hours, filter, filtrate is regulated pH value to 7.0～7.5 with 20% sodium hydroxide solution, places 24 hours, filter, after reclaiming ethanol, add an amount of water for injection and active carbon, placement is spent the night, filter, filtrate adds polyoxyethylene sorbitan monoleate and each 10ml of benzyl alcohol, regulates pH value 7.0～7.5 with 20% hydrochloric acid solution, adds the injection water to 1000ml, filter, embedding, sterilization, promptly.
Function cures mainly: promoting blood circulation to remove blood stasis, strengthening the tendons and bones, wind dispelling pain relieving; Be used for vertebrae hyperosteogeny disease, also effective in cure to rheumatic arthralgia.
Owing to reasons such as technologies of preparing, the research of the compatibility of Chinese medicine injection can not show a candle to Western medicine, and causes allergy easily.Existing FUFANG BANBIANLIAN ZHUSHEYE does not still have similar other dosage form listings at present.This kind Chinese medicine is an effective component extracting from Chinese crude drug, the intravital concentrated solution of Gong the injection of making.Because the extensive use of modern biotechnology in the natural drug exploitation, the domestic herbal species that is used to inject is more and more, and application is more and more wider clinically, and adverse reaction rate also increases.According to data: the dosage form of Chinese patent medicine adverse reaction rate is that injection accounts for 31% successively, tablet accounts for 24%, pill accounts for 10%.Chinese medicine untoward reaction consequence is serious, and Chinese medicine and preparation thereof cause anaphylactic shock and rank first place, and the trend that increases is arranged year by year, this with use clinically more relevant.Chinese medicine composition more complicated is injected human body with this mixture from blood vessel, forces human body to go metabolism, and itself has just had potential danger, if again with the other medicines compatibility, contingent reaction often is difficult to prediction.The compatibility difficulty of Chinese medicine is bigger, and incompatibility is studied the compatibility of Chinese medicine without ready patterns to follow, and it is perfect also to can not show a candle to Western medicine.Chinese medicine injection causes allergy easily, and reason is to contain albumen, polysaccharide, polypeptide etc. in its composition; The purity of extracting is not enough; Plurality of Chinese is extracted, and each composition interacts; Contain cosolvent, solubilizing agent etc.
In addition, the oral formulations of the oral formulations of most drug, especially Chinese medicine 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, regular meeting produces 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.The production technology of conventional oral formulations is more complicated also, and 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, be to replenish the existing vertebrae hyperosteogeny disease that is used for, the deficiency of the oral drug preparation of disease treatments such as rheumatic arthralgia provides a kind of bioavailability height, and has quick release, quick produce effects, the medicament contg height is taken accurate measurement, and is cheap, no acute allergic reaction or untoward reaction, and be convenient to the strong bone drop pill that transports and carry.Strong bone drop pill involved in the present invention is a raw material with the ZHANGU, is prepared from the pharmaceutically suitable carrier as substrate.
Be prepared by the following technical solutions, can obtain strong bone drop pill involved in the present invention:
[preparation method]
1. the preparation of drug extract: it is an amount of to get ZHANGU, cleans, with 20% soak with ethanol more than 72 hours, get supernatant, filter, filtrate concentrates 8 times that most throw the ZHANGU weight of throwing, add ethanol and make and contain alcohol amount and reach 80%, stir, placed 12 hours, filter, filtrate is regulated pH value to 7.0～7.5 with 20% sodium hydroxide solution, places 24 hours, filters, filtrate recycling ethanol is concentrated into relative density and is 1.25～1.35 thick paste promptly; Or continue to make drying, 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 in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, 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 drug standard WS promulgated by the ministries or commissions of the Central Government
3The JIANGU ZHUSHEYE that the preparation method that provides among-the B-2768-97 is prepared from is a kind of promoting blood circulation to remove blood stasis that has, strengthening the tendons and bones, the wind dispelling analgesic effect, be used for vertebrae hyperosteogeny disease, the pure Chinese medicine injection of disease treatments such as rheumatic arthralgia, through clinical verification, determined curative effect is the common drug that clinical and family is used for the treatment of this type of disease.
Owing to reasons such as technologies of preparing, the research of the compatibility of Chinese medicine injection can not show a candle to Western medicine, and causes allergy easily.Existing FUFANG BANBIANLIAN ZHUSHEYE does not still have similar other dosage form listings at present.This kind Chinese medicine is an effective component extracting from Chinese crude drug, the intravital concentrated solution of Gong the injection of making.Because the extensive use of modern biotechnology in the natural drug exploitation, the domestic herbal species that is used to inject is more and more, and application is more and more wider clinically, and adverse reaction rate also increases.According to data: the dosage form of Chinese patent medicine adverse reaction rate is that injection accounts for 31% successively, tablet accounts for 24%, pill accounts for 10%.Chinese medicine untoward reaction consequence is serious, and Chinese medicine and preparation thereof cause anaphylactic shock and rank first place, and the trend that increases is arranged year by year, this with use clinically more relevant.Chinese medicine composition more complicated is injected human body with this mixture from blood vessel, forces human body to go metabolism, and itself has just had potential danger, if again with the other medicines compatibility, contingent reaction often is difficult to prediction.The compatibility difficulty of Chinese medicine is bigger, and incompatibility is studied the compatibility of Chinese medicine without ready patterns to follow, and it is perfect also to can not show a candle to Western medicine.Chinese medicine injection causes allergy easily, and reason is to contain albumen, polysaccharide, polypeptide etc. in its composition; The purity of extracting is not enough; Plurality of Chinese is extracted, and each composition interacts; Contain cosolvent, solubilizing agent etc.
In addition, the oral formulations of the oral formulations of most drug, especially Chinese medicine 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, regular meeting produces 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.The production technology of conventional oral formulations is more complicated also, and 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.
Strong bone drop pill involved in the present invention is compared the following beneficial effect of tool with JIANGU ZHUSHEYE:
1. strong bone drop pill involved in the present invention; utilize surfactant to be substrate; make solid dispersion with containing Chinese medicine ZHANGU extraction of active ingredients thing, make medicine be molecule, colloid or microcrystalline state and be scattered in the substrate, the total surface area of medicine increases; and substrate is hydrophilic; 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.
2. strong bone drop pill 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. strong bone drop 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. strong bone drop pill involved in the present invention, stable in properties than injection, has the anaphylaxis of not being prone to, and side effect is little, also has advantages such as high bioavailability simultaneously.
5. 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.
6. 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 strong bone drop pill of the present invention.
[first group; The test of single-matrix]
1. the preparation of drug extract: make in advance according to [preparation method 1] that to contain Chinese medicine ZHANGU extraction of active ingredients thing dry powder standby;
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, drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the strong bone drop pill of different size.
[result of the test]
Test 1: for observe drug extract and different substrates when 1: 1 the proportioning prepared strong bone drop pill in qualitative difference, according to 1: 1 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 strong bone drop pill in qualitative difference, according to 1: 3 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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 strong bone drop pill in qualitative difference, according to 1: 9 ratio, with drug extract respectively with Polyethylene Glycol
1000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
10000, Polyethylene Glycol
20000, pharmaceutically suitable carrier such as span 40, polyoxyethylene stearate 40 esters, poloxamer, 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. the preparation of drug extract: make in advance according to [preparation method 1] that to contain Chinese medicine ZHANGU extraction of active ingredients thing dry powder 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. proportioning: with g or kg is unit, drug extract: substrate=1: 1～1: 9;
4. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the strong bone drop pill of different size.
[result of the test]
Test 4: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained strong bone drop pill when 1: 1 proportioning, with g or kg is unit, 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 obtained strong bone drop pill when 1: 3 proportioning, with g or kg is unit, 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 obtained strong bone drop pill when 1: 9 proportioning, with g or kg is unit, 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 obtained strong bone drop pill when 1: 1 proportioning, with g or kg is unit, 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 obtained strong bone drop pill when 1: 3 proportioning, with g or kg is unit, 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 obtained strong bone drop pill when 1: 9 proportioning, with g or kg is unit, 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 obtained strong bone drop pill when 1: 1 proportioning, with g or kg is unit, 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 experiments and the results are shown in Table 10.
Test 11: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained strong bone drop pill when 1: 3 proportioning, with g or kg is unit, 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 experiments and the results are shown in Table 11.
Test 12: in order to observe the mass discrepancy of drug extract and mixed-matrix obtained strong bone drop pill when 1: 9 proportioning, with g or kg is unit, 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 experiments and the results are shown in Table 12.
The group practices of table 1 drug extract and single-matrix (drug extract: substrate=1: 1)
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 1000 | 50.0 | 64 | <30 | >10 | + |
| Polyethylene Glycol 40000 | 50.0 | 80 | <30 | >10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 82 | <30 | >10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 83 | <30 | >10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 83 | <30 | >10 | ++ |
| Span 40 | 50.0 | 61 | <30 | >10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 80 | <30 | >10 | + |
| Poloxamer | 50.0 | 82 | <30 | >10 | + |
| Sodium lauryl sulphate | 50.0 | 62 | >30 | >10 | ++ |
| Stearic acid | 50.0 | 60 | >30 | >10 | ++ |
| Sodium stearate | 50.0 | 60 | >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 | 79 | <30 | >10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 86 | <30 | <10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 89 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 91 | <30 | <10 | +++ |
| Span 40 | 25.0 | 63 | <30 | <10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 80 | <30 | >10 | ++ |
| Poloxamer | 25.0 | 87 | <30 | <10 | +++ |
| Sodium lauryl sulphate | 25.0 | 74 | >30 | >10 | +++ |
| Stearic acid | 25.0 | 73 | >30 | >10 | +++ |
| Sodium stearate | 25.0 | 70 | >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 | 84 | <30 | >10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 89 | <30 | <10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 90 | <30 | <10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 91 | <30 | <10 | +++ |
| Span 40 | 10.0 | 68 | <30 | <10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 83 | <30 | <10 | ++ |
| Poloxamer | 10.0 | 89 | <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 | 84 | <30 | >10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 50 | 82 | <30 | >10 | ++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 50 | 76 | <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 | 89 | <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 | 82 | <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 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 1 | 10 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10 | 85 | <30 | >10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 1 | 10 | 83 | <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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 50 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 50 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 50 | 87 | <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 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 25 | 89 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 5 | 25 | 89 | <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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 5 | 10 | 90 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 5 | 10 | 90 | <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 | 91 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 50 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 50 | 90 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 50 | 87 | <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 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 25 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 25 | 89 | <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 | 90 | <30 | <10 | +++ |
| Poloxamer: Polyethylene Glycol=1: 10 | 10 | 91 | <30 | <10 | +++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 10 | 10 | 91 | <30 | <10 | +++ |
| Betacyclodextrin: Polyethylene Glycol=1: 10 | 10 | 89 | <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 is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.
Claims (2)
1. a strong bone drop pill that is used for the treatment of vertebrae hyperosteogeny disease, rheumatic arthralgia is a raw material with the Chinese medicine ZHANGU, is prepared from the pharmaceutically suitable carrier as substrate, it is characterized in that:
(1) it is an amount of to get ZHANGU, cleans, with 20% soak with ethanol more than 72 hours, get supernatant, filter, filtrate concentrates 8 times that most throw the ZHANGU weight of throwing, add ethanol and make and contain alcohol amount and reach 80%, stir, placed 12 hours, filter, filtrate is regulated pH value to 7.0～7.5 with 20% sodium hydroxide solution, places 24 hours, filters, filtrate recycling ethanol is concentrated into relative density and is 1.25～1.35 thick paste promptly; Or continue to make drying, and be ground into dry powder, promptly get the extract that contains the ZHANGU effective ingredient, standby;
(2) described substrate is the mixture of Polyethylene Glycol and polyoxyethylene stearate 40 esters or carboxymethyl starch sodium; With g or kg is unit, and the mixed proportion of polyoxyethylene stearate 40 esters or carboxymethyl starch sodium and Polyethylene Glycol is 1: 1～1: 10, and the ratio of described extract and substrate is 1: 3;
(3) according to the given ratio of prescription, accurately take by weighing described extract and substrate, be placed on heating while stirring in the heating container, standby until the fused solution that obtains containing described extract and substrate and/or emulsion and/or suspension;
(4) temperature control system of adjustment drop pill machine makes the water dropper heating of drop pill machine and maintains the temperature at 50 ℃～90 ℃, and the condensing agent cooling also maintains the temperature at 40 ℃～-5 ℃;
When (5) treating that dropping-pill machine head and condensing agent reach described state of temperature respectively, will contain the fused solution of described extract and substrate and/or emulsion and/or suspension and place in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding promptly.
2. strong bone drop pill as claimed in claim 1 is characterized in that: described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510087059XA CN100375616C (en) | 2005-07-26 | 2005-07-26 | Bone strengthening dripping pills with Premena fulva craib as raw material and method for preparing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510087059XA CN100375616C (en) | 2005-07-26 | 2005-07-26 | Bone strengthening dripping pills with Premena fulva craib as raw material and method for preparing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1720946A CN1720946A (en) | 2006-01-18 |
| CN100375616C true CN100375616C (en) | 2008-03-19 |
Family
ID=35911783
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB200510087059XA Expired - Fee Related CN100375616C (en) | 2005-07-26 | 2005-07-26 | Bone strengthening dripping pills with Premena fulva craib as raw material and method for preparing the same |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100375616C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104415171A (en) * | 2013-08-27 | 2015-03-18 | 成都力思特制药股份有限公司 | Bone-strengthening injection liquid and preparation method thereof |
| CN103705652A (en) * | 2013-12-16 | 2014-04-09 | 广西南宁百会药业集团有限公司 | Improved method of bone strengthening injection production process |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1098004A (en) * | 1994-02-19 | 1995-02-01 | 南宁制药企业集团公司 | Jiangu zhusheye |
-
2005
- 2005-07-26 CN CNB200510087059XA patent/CN100375616C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1098004A (en) * | 1994-02-19 | 1995-02-01 | 南宁制药企业集团公司 | Jiangu zhusheye |
Non-Patent Citations (3)
| Title |
|---|
| 上海科学技术出版社. 范碧亭.中药药剂学，第1期. 1997 * |
| 中华人民共和国卫生部. 中华人民共和国卫生部药典委员会.中华人民共和国卫生部药品标准（中药成方制剂第十四册）. 1997 * |
| 黄毛豆腐柴化学成分、药理研究及临床应用进展. 潘洪平，荆树汉.广西医学，第24卷第3期. 2002 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1720946A (en) | 2006-01-18 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100375614C (en) | Dripping pills with jaundice eliminating liver protecting functions and its preparation method | |
| CN100375616C (en) | Bone strengthening dripping pills with Premena fulva craib as raw material and method for preparing the same | |
| CN1720948A (en) | Dripping pills of lllicium henryi dripping pills and method for preparing the same | |
| CN1316960C (en) | Compound mactra clam drip pill and its preparation method | |
| CN100406003C (en) | Dripping pills of abastard speedwell and its preparation process | |
| CN1301100C (en) | Nauclea officinalis drip pill and its preparation method | |
| CN1301099C (en) | Earthworm drip pill and its preparation method | |
| CN100453073C (en) | Compound radical lobelia dripping pill and its preparing method | |
| CN1322854C (en) | Cold drop pills of mulberry and ginger in use for eliminating draft, clearing away heat, and preparing method | |
| CN100486598C (en) | Bupleurum root asarum herb dripping pill and its preparing method | |
| CN1316959C (en) | Acanthopanax bark-ginseng-Chinese angelica root-astragalus root dripping pill and its preparing method | |
| CN100358496C (en) | 'Xingnaojing' dripping pills for treating cephalitis and hepatic coma and preparation process thereof | |
| CN1315467C (en) | liver-clearing dropping pill for treating hepatitis and its preparing method | |
| CN100453072C (en) | Isatis root drops and preparation thereof | |
| CN100348178C (en) | 'Ganjing' dripping pills for treating liver disease and its preparation | |
| CN100348171C (en) | Yujin drop pill for clearing away the heat-evil and expelling superficial evils and its preparation method | |
| CN100382788C (en) | Drop pill for treating hematuresis and process for preparing the same | |
| CN1292738C (en) | Ginseng-pilose antler dripping pill for tonifying heart and kidney and its preparing method | |
| CN100348173C (en) | Drop pills of honeysuckle flower in use for clearing away heat and toxic materials and preparing method | |
| CN1720950A (en) | Compound drop pills of Chinese angelica and its preparation method | |
| CN1322858C (en) | Geranol drip pill and its preparation method | |
| CN100542519C (en) | It with the Flos lupuli extractum pulmonary-toxin-clearing dropping pill of raw material and preparation method thereof | |
| CN1686339A (en) | Compound cynomorium drip pill and its preparation method | |
| CN1720962A (en) | Dripping pills for tonifying kidney and strengthening bone and method for preparing the same | |
| CN1709461A (en) | Calculus bovis detoxifying dropping pill, and its preparing method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |