CN1742995A - Zuanshanfeng guttage pill and preparing method - Google Patents
Zuanshanfeng guttage pill and preparing method Download PDFInfo
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Abstract
The Chinese medicine composite zuanshanfeng dripping pills preparation for curing the diseases of cold pain in the lumbus and knees, numbness of the limbs and inhibited bending and stretching resulted from arthralgia due to wind-cold-dampress is made up by using extract of 7 Chinese medicinal materials of zuanshanfeng. berchemia sinica, rubia maillardi, clematis root, moghania root, millettia hirsutissima and alpinia japonica as raw material and pharmaceutical aueptable carrier through a certain preparation process.
Description
Technical field
The present invention relates to a kind of expelling wind and removing dampness that has, the dissipating blood stasis analgesia, relaxing muscles and tendons and activating QI and blood in the collateral, be used for the chills and pain of the waist and kness that anemofrigid-damp arthralgia causes, numb limbs and tense tendons, the pharmaceutical composition of treatment for diseases such as activities adverse is a kind of drug composition oral preparation that feedstock production forms with the extract that contains pharmaceutically active ingredient in 7 flavors such as Radix Fissistigmatis Oldhamii, Radix Berchemiae Giraldianae, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Radix Clematidis, Radix Flemingiae Philippinensis, Caulis Spatholobi, Alpinia japonica (Thunb.) Miq. particularly.
Background technology
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Radix Fissistigmatis Oldhamii syrup that the preparation method that provides among-the B-2011-95 is prepared from, it is a kind of expelling wind and removing dampness that has, the dissipating blood stasis analgesia, relaxing muscles and tendons and activating QI and blood in the collateral is used for the chills and pain of the waist and kness that anemofrigid-damp arthralgia causes, numb limbs and tense tendons, the oral liquid of treatment for diseases such as activities adverse, 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-2011-95 and technology and brief description:
Prescription: Radix Fissistigmatis Oldhamii 1000g, Radix Berchemiae Giraldianae 63g, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae) 25g, Radix Clematidis 63g, Radix Flemingiae Philippinensis 125g, Caulis Spatholobi 125g, Alpinia japonica (Thunb.) Miq. 30g.
Method for making: above seven flavors, get Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Alpinia japonica (Thunb.) Miq. is ground into coarse powder, to colourless, it is standby to collect percolate with the Chinese liquor percolation that contains ethanol 50%.The five tastes such as all the other Radix Fissistigmatis Oldhamii decoct with water secondary, and each 3 hours, collecting decoction was concentrated into relative density and is 1.06 (heat is surveyed), put coldly, add in the above-mentioned percolate, stir evenly, and leave standstill 48 hours, filter.Other gets sucrose 500g, makes simple syrup and adds, and stirs evenly, and adds benzoic acid 2g again, adds water to 1000ml, stirs evenly, and filters, promptly.
Function cures mainly: expelling wind and removing dampness, dissipating blood stasis analgesia, relaxing muscles and tendons and activating QI and blood in the collateral.Be used for the chills and pain of the waist and kness that anemofrigid-damp arthralgia causes, numb limbs and tense tendons, diseases such as activities adverse.
Rheumatoid and rheumatic arthritis are common clinical, belong to motherland's medical science " arthromyodynia " category.The traditional Chinese medical science is thought owing to wind, cold, wet gas is assorted is disease, impatency meridians pathogenic QI in the body blood, and numbness hinders joint, muscle and sends out.So adopt dispel the wind, cold expelling, dehumidifying and relax through the basic principle for the treatment arthromyodynia such as collateral dredging.In the Radix Fissistigmatis Oldhamii syrup, Radix Fissistigmatis Oldhamii, Radix Clematidis, Radix Flemingiae Philippinensis, Alpinia japonica (Thunb.) Miq., Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae) nature and flavor all belong to hot using warming therapy product, all have dispel the wind, cold expelling, the effect that dehumidifies, invigorate blood circulation.In the side Radix Berchemiae Giraldianae Caulis Spatholobi except that above-mentioned effect, the flat merit (seeing " Shaanxi Chinese herbal medicine ") that invigorating the spleen and benefiting QI is still arranged of Radix Berchemiae Giraldianae puckery; Caulis Spatholobi property bitter but sweet flavor temperature, the effect that having nourishes blood enriches blood clinically is used for the treatment of various anemiaes; Two medicines play " ... the agent of spleen reinforcing, Tu Wang then can win wet " in this side, " control wind and control blood earlier, the blood sector-style is from going out ".(" Medicine Comprehended numbness ") has the effect of strengthening vital QI to eliminate pathogenic factors, and all medicines share, play expelling wind and dampness altogether, relaxing muscles and tendons and activating QI and blood in the collateral is removed numbness five, eliminating evil and do not hinder just purpose (Yan Guilan. Radix Fissistigmatis Oldhamii syrup treatment rheumatoid and rheumatic arthritis 151 examples. Chinese Industrial Standards (CIS) number of the edition CN61-1105/R).
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, and oral liquid also exists dose and is difficult to accurately, take easily do not wait not enough.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.
The drop pill that adopts solid dispersion technology to be prepared from has thoroughly changed the existing defective of conventional oral formulations from the frame mode of medicine.Owing to make the active component of medicine and substrate fusion be one and form liquid in advance, make active constituents of medicine fully dissolve and be dispersed in uniformly in the chemical lattice of substrate fused solution, thereby make the effective surface area of drug molecule (group) increase greatly, improved the contact area of active constituents of medicine dissolving back with gastrointestinal tract mucosa; Owing to the ease of solubility of substrate, make drop pill after taking, can dissolve rapidly, and absorbed simultaneously, played high speed, good effect efficiently by gastrointestinal tract mucosa.In addition because the medicament contg height of drop pill, volume is little, dissolution velocity is fast, dissolving back mouthfeel is good, also can adopt the mode of sublingual administration, can make effective ingredient directly absorb and enter blood circulation by the Sublingual mucosa, avoid the first pass effect of conventional oral formulations effectively, also avoid some drugs gastrointestinal tract to be produced the side effect that stimulates without gastrointestinal tract and liver.
Yet, because the preparation technology of drop pill is still not really ripe, its relevant device does not yet reach standardized degree, when utilizing the prior art for preparing drop pill, product quality is subjected to the physicochemical property of medicine, the kind of substrate and with the ratio of medicament mixed, factor affecting such as condensing agent and temperature thereof, the rounding rate, the quality index of the relevant dropping pill formulation of defined differs bigger in indexs such as the ball method of double differences is different and the national drug standards, such product is in use having a strong impact on the accuracy of dosage, also make the qualification rate of product reduce aborning, increased production cost, thereby also indirect increase patient's drug cost, thereby make its practicality also decrease.
Summary of the invention
Purpose of the present invention, be to replenish the existing chills and pain of the waist and kness that anemofrigid-damp arthralgia causes that is used for, numb limbs and tense tendons, the deficiency of the oral drug preparation of treatment for diseases such as activities adverse provides a kind of quality index that can satisfy the relevant dropping pill formulation of defined in the national drug standards fully, also possesses simultaneously the bioavailability height, release fast, quick produce effects, taking convenience, cheap, and free of contamination aborning Zuanshanfeng guttage pill.Zuanshanfeng guttage pill involved in the present invention is a raw material with the extract that contains 7 flavor Chinese medicines such as Radix Fissistigmatis Oldhamii, Radix Berchemiae Giraldianae, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Radix Clematidis, Radix Flemingiae Philippinensis, Caulis Spatholobi, Alpinia japonica (Thunb.) Miq., is prepared from the pharmaceutically suitable carrier as substrate.Be prepared by the following technical solutions, can obtain Anshen Bunao drip ball involved in the present invention:
[preparation method]
1. raw material: the extract that contains pharmaceutically active ingredient in 7 flavors such as Radix Fissistigmatis Oldhamii, Radix Berchemiae Giraldianae, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Radix Clematidis, Radix Flemingiae Philippinensis, Caulis Spatholobi, Alpinia japonica (Thunb.) Miq.;
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, drug extract: substrate=1: 1～1: 9;
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, until the fused solution and/or emulsion and/or the suspension that obtain containing drug extract and substrate, standby;
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, 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 ℃;
6. when treating in dropping-pill machine head and the condensation column that the temperature of condensing agent reaches desired state of temperature respectively, above-mentioned medicinal liquid is placed 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.
[attached: the preparation of drug extract]
Get Radix Fissistigmatis Oldhamii 1000g, Radix Berchemiae Giraldianae 63g, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae) 25g, Radix Clematidis 63g, Radix Flemingiae Philippinensis 125g, Caulis Spatholobi 125g, Alpinia japonica (Thunb.) Miq. 30g, more than seven the flavor, get Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Alpinia japonica (Thunb.) Miq. is ground into coarse powder, to colourless, it is standby to collect percolate with the Chinese liquor percolation that contains ethanol 50%; The five tastes such as all the other Radix Fissistigmatis Oldhamii decoct with water secondary, and each 3 hours, collecting decoction, being concentrated into relative density is 1.06, puts cold, add in the above-mentioned percolate, stir evenly, left standstill 48 hours, filter, filtrate is concentrated into relative density for more than or equal to 1.3 thick paste, or convection drying, is ground into dry powder, promptly.
[beneficial effect]
According to drug standard WS promulgated by the ministries or commissions of the Central Government
3The Radix Fissistigmatis Oldhamii syrup that the preparation method that provides among-the B-2011-95 is prepared from, it is a kind of chills and pain of the waist and kness that anemofrigid-damp arthralgia causes that is used for, numb limbs and tense tendons, the oral liquid of treatment for diseases such as activities adverse, 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, and the syrups preparation also exists dose and is difficult to accurately, take easily do not wait not enough.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.
The drop pill that adopts solid dispersion technology to be prepared from has thoroughly changed the existing defective of conventional oral formulations from the frame mode of medicine.Yet, because the preparation technology of drop pill is still not really ripe, its relevant device does not yet reach standardized degree, when utilizing the prior art for preparing drop pill, product quality is subjected to the physicochemical property of medicine, the kind of substrate and with the ratio of medicament mixed, factor affecting such as condensing agent and temperature thereof, the rounding rate, the quality index of the relevant dropping pill formulation of defined differs bigger in indexs such as the ball method of double differences is different and the national drug standards, such product is in use having a strong impact on the accuracy of dosage, also make the qualification rate of product reduce aborning, increased production cost, thereby also indirect increase patient's drug cost, thereby make its practicality also decrease.
Zuanshanfeng guttage pill involved in the present invention is compared with the Radix Fissistigmatis Oldhamii syrup has following beneficial effect:
1. Zuanshanfeng guttage pill involved in the present invention, scope, proportioning and the process conditions of used adjuvant have been determined by a large amount of tests, and select the equipment of function admirable for use, make technology of preparing disclosed in this invention more be useful for industrial production requirement, the yield rate height, accurate measurement, production cost is lower.
2. Zuanshanfeng guttage pill involved in the present invention utilizes surfactant to be substrate, with the extract and the vitamin B that contain pharmaceutically active ingredient in 6 flavors such as Cornu Cervi Pantotrichum, Radix Polygoni Multiflori, Herba Epimedii, Rhizoma Zingiberis, Radix Glycyrrhizae, Fructus Jujubae
1Make solid dispersion together, making medicine be molecule, colloid or microcrystalline state is scattered in the substrate, the total surface area of medicine increases, and substrate is hydrophilic, contacts promptly with saliva and dissolves rapidly, and absorbed by oral mucosa, can make medicine molten microgranule or the solution of loosing into rapidly, thereby make the dissolving of medicine and absorb to accelerate, thereby improved bioavailability, bring into play efficient, quick-acting effects etc.; Simultaneously, Zuanshanfeng guttage pill involved in the present invention, the influence of not taken food, all can containing take ante cibum after meal, also can not produce any residual harmful substance at gastric, thereby make that patient's medication is safer.
3. Zuanshanfeng guttage pill involved in the present invention mixes medicine material 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 Zuanshanfeng guttage pill of the present invention.
[selection of prescription]
1. raw material: it is standby to make the extract that contains pharmaceutically active ingredient in 7 flavors such as Radix Fissistigmatis Oldhamii, Radix Berchemiae Giraldianae, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Radix Clematidis, Radix Flemingiae Philippinensis, Caulis Spatholobi, Alpinia japonica (Thunb.) Miq. 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 drug extract and substrate (with g or kg is unit, by weight):
Drug extract: substrate=1: 1～1: 9;
5. the process that provides according to [preparation method] 4～7 is prepared, and can obtain the Zuanshanfeng guttage pill of different size.
Test the test of a single-matrix
Cooperating prepared Zuanshanfeng guttage pill 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 Zuanshanfeng guttage pill 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 Zuanshanfeng guttage pill 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 Zuanshanfeng guttage pill 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 | 77 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 6000 | 50.0 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 10000 | 50.0 | 77 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 20000 | 50.0 | 76 | ＜30 | ＞10 | ++ |
| Span 40 | 50.0 | 60 | ＜30 | ＞10 | ++ |
| Polyoxyethylene stearate 40 esters | 50.0 | 73 | ＜30 | ＞10 | ++ |
| Poloxamer | 50.0 | 77 | ＜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 | 78 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 25.0 | 87 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 25.0 | 86 | ＜30 | ＜10 | +++ |
| Span 40 | 25.0 | 63 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 25.0 | 80 | ＜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 | 83 | ＜30 | ＞10 | ++ |
| Polyethylene Glycol 4000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 6000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 10000 | 10.0 | 88 | ＜30 | ＜10 | +++ |
| Polyethylene Glycol 20000 | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Span 40 | 10.0 | 66 | ＜30 | ＞10 | +++ |
| Polyoxyethylene stearate 40 esters | 10.0 | 83 | ＜30 | ＞10 | ++ |
| Poloxamer | 10.0 | 86 | ＜30 | ＜10 | +++ |
| Sodium lauryl sulphate | 10.0 | 73 | ＞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 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 50.0 | 88 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 50.0 | 89 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 50.0 | 81 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 50.0 | 82 | ＜30 | ＞10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 50.0 | 83 | ＜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 | 79 | ＜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 | 90 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 25.0 | 82 | ＜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 | 87 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 5 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| S40 ester: Polyethylene Glycol=1: 10 | 10.0 | 89 | ＜30 | ＜10 | +++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 1 | 10.0 | 86 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 5 | 10.0 | 88 | ＜30 | ＜10 | ++ |
| Beta cyclodextrin: Polyethylene Glycol=1: 10 | 10.0 | 89 | ＜30 | ＜10 | ++ |
| Carboxymethyl starch sodium: Polyethylene Glycol=1: 1 | 10.0 | 85 | ＜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: 0.5: 0.5: 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: 0.5: 0.5: 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: 0.5: 0.5: 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. one kind is used for the chills and pain of the waist and kness that anemofrigid-damp arthralgia causes, numb limbs and tense tendons, the pharmaceutical composition Zuanshanfeng guttage pill of treatment for diseases such as activities adverse, with the extract that contains pharmaceutically active ingredient in Radix Fissistigmatis Oldhamii, Radix Berchemiae Giraldianae, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Radix Clematidis, Radix Flemingiae Philippinensis, Caulis Spatholobi, Alpinia japonica (Thunb.) Miq. etc. 7 flavor is raw material, 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. Zuanshanfeng guttage pill as claimed in claim 1, it is characterized in that described drug extract is made by following method: get Radix Fissistigmatis Oldhamii 1000g, Radix Berchemiae Giraldianae 63g, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae) 25g, Radix Clematidis 63g, Radix Flemingiae Philippinensis 125g, Caulis Spatholobi 125g, Alpinia japonica (Thunb.) Miq. 30g, more than seven the flavor, get Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Alpinia japonica (Thunb.) Miq. is ground into coarse powder, to colourless, it is standby to collect percolate with the Chinese liquor percolation that contains ethanol 50%; The five tastes such as all the other Radix Fissistigmatis Oldhamii decoct with water secondary, and each 3 hours, collecting decoction, being concentrated into relative density is 1.06, puts cold, add in the above-mentioned percolate, stir evenly, left standstill 48 hours, filter, filtrate is concentrated into relative density for more than or equal to 1.3 thick paste, or convection drying, is ground into dry powder, promptly.
3. Zuanshanfeng guttage pill 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. Zuanshanfeng guttage pill 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. Zuanshanfeng guttage pill 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 Zuanshanfeng guttage pills, 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 any one or the two or more mixture in cetomacrogol 1000～Macrogol 2000 0.
8. preparation method that is used for the described Zuanshanfeng guttage pill of claim 1 is characterized in that being made of following process:
8.1 raw material: the extract that contains pharmaceutically active ingredient in 7 flavors such as Radix Fissistigmatis Oldhamii, Radix Berchemiae Giraldianae, Herba Chloranthi Henryi (Herba Choranthi seu Lysimachiae), Radix Clematidis, Radix Flemingiae Philippinensis, Caulis Spatholobi, Alpinia japonica (Thunb.) Miq.;
8.2 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;
8.3 proportioning: with g or kg is unit, 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, until the fused solution and/or emulsion and/or the suspension that obtain containing drug extract and substrate, standby;
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, above-mentioned medicinal liquid is placed 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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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102477039A (en) * | 2010-11-24 | 2012-05-30 | 贵州大学 | Method for preparing Fissistigma oldhamii lactam alkali compound and application thereof to preparing anti-tumour medicine |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102477039A (en) * | 2010-11-24 | 2012-05-30 | 贵州大学 | Method for preparing Fissistigma oldhamii lactam alkali compound and application thereof to preparing anti-tumour medicine |
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