CN1311841C - Soft capsule preparation for promoting blood circulation and relieving pain and preparation method thereof - Google Patents
Soft capsule preparation for promoting blood circulation and relieving pain and preparation method thereof Download PDFInfo
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- CN1311841C CN1311841C CNB2003101150864A CN200310115086A CN1311841C CN 1311841 C CN1311841 C CN 1311841C CN B2003101150864 A CNB2003101150864 A CN B2003101150864A CN 200310115086 A CN200310115086 A CN 200310115086A CN 1311841 C CN1311841 C CN 1311841C
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Abstract
The invention relates to a soft capsule preparation for promoting blood circulation and relieving pain and process for preparation, the process for preparation and formulation, mainly prepared from Chinese angelica root, native copper, wood louse, notoginseng, frankincense and boneol, the three preparation methods are adopted, wherein part of the medicinal materials are directly crushed, the effective constituents of the medicinal materials are extracted by different processes, a right amount of reasonable auxiliary materials are added, grinding and constantly stirring and mixing are carried out, a standby solution is prepared, then a soft capsule skin is prepared by gelatin, a soft capsule machine is started, the standby solution and the soft capsule skin are pressed to prepare the soft capsule for promoting blood circulation and relieving pain, and the quality standard is improved, the soft capsule and the soft capsule formulation prepared by the series methods avoid the defects of powder and hard capsule, have the advantages of rapid disintegration, high bioavailability, good stability, beautiful appearance, convenient carrying, convenient taking and the like, are oral soft capsule preparations with obvious effects of treating traumatic injury, clinical pre-pharmacological tests prove that the effect of the soft capsule for promoting blood circulation and relieving pain is superior to that of the powder for promoting blood circulation and relieving pain.
Description
Technical field:
The present invention relates to a kind of promoting blood circulation and stopping pain soft capsule preparation and preparation method thereof, particularly Chinese medicine medicine of the promoting blood circulation and stopping pain of being made by Radix Angelicae Sinensis, Radix Notoginseng, Olibanum, Borneolum Syntheticum, Eupolyphaga Seu Steleophaga, Pyritum and preparation method thereof belongs to the pharmaceutical product field.
Background technology:
Promoting blood circulation and stopping pain soft capsule of the present invention, its prescription comes from the huoxue zhitong powder, huoxue zhitong san in the Tang Dynasty well-known doctor family's Sun Simiao " prescriptions worth thousand gold " the earliest, and huoxue zhitong powder, huoxue zhitong san now records in one one of the Pharmacopoeia of the People's Republic of China (version in 2000).The promoting blood circulation and stopping pain soft capsule is exactly to have passed through to improve the soft capsule preparation of making on inferior this basis.
The Chinese medicine medicament composing prescription of the promoting blood circulation and stopping pain of being made by Radix Angelicae Sinensis, Radix Notoginseng, Olibanum, Borneolum Syntheticum, Eupolyphaga Seu Steleophaga, Pyritum is reasonable, and compatibility is simplified, determined curative effect, and the clinical practice reaction is fine, is called as " the traumatology panacea " of treatment traumatic injury, swelling and pain due to blood stasis.
At present, the corresponding disease of western medicine, mainly based on nonsteroidal antiinflammatory and analgesic, by contrast, the Chinese medicine medicine of promoting blood circulation and stopping pain not only can pain relieving can also removing blood stasis and activating blood flow, have no side effect.Compare with similar drug, raw material is of high quality and at a reasonable price to be easy to get.
The former dosage form of promoting blood circulation and stopping pain soft capsule is: powder and hard capsule.Listed ministry standard [WS3-091 (Z-81)-95 (Z)] in, powder becomes divided dose inaccurate, take inconvenient shortcoming, there are many problems in hard capsule, and is big as dose, needs No. 0 capsule 4-6 grain at every turn, Borneolum Syntheticum is big to stomach irritation in the prescription, the hygiology index is difficult to reach a standard, and the copper of Pyritum and arsenic content are higher, take for a long time the human body toxic side effect.
Promoting blood circulation and stopping pain soft capsule of the present invention adopts the novel form new technology, its Chinese crude drug is partly beaten powder, extracting section, and (take inconvenience, it is inhomogeneous that Borneolum Syntheticum mixes to avoid the shortcoming of powder and hard capsule, hygiology is difficult to control, quality instabilities etc.), it is rapid to have a disintegrate, the bioavailability height, good looking appearance, easy to carry, advantages such as taking convenience, the exploitation of this product has tangible innovation meaning.
Summary of the invention:
Promoting blood circulation and stopping pain soft capsule of the present invention, its prescription is composed as follows: Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g, the preparation that this recipe quantity is made can be made into 1000 of promoting blood circulation and stopping pain soft capsules.This prescription is formed the huoxue zhitong powder, huoxue zhitong san prescription crude drug that is selected from one one of the Pharmacopoeia of the People's Republic of China (version in 2000) and is constituted.
Promoting blood circulation and stopping pain soft capsule preparation of the present invention, form by soft capsule shell and content, content is made up of through extracting active component and the pharmaceutic adjuvant be processed into the raw material of above prescription, pharmaceutic adjuvant be can with the aqueous material of active component mix homogeneously, be selected from PEG400 (PEG400), Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, Cera Flava etc., the weight proportion of active component and pharmaceutic adjuvant, be active component by weight: pharmaceutic adjuvant=1: 0.5-1: 5; Wherein in every soft capsule, the content of active component is by the normal capsules grain, and every contains active component 0.01～0.5 gram; Soft capsule shell prepares with conventional method, is generally filled a prescription in certain proportion by gelatin, G ﹠ W and makes, and by weight, gelatin, G ﹠ W preferred proportion are 10: 2～5: 7-15.
Soft capsule of the present invention is preferably filled a prescription and consisted of every soft capsule and contain: active component 0.01～0.5 gram, PEG400 or vegetable oil are the 0.01-0.5 gram; Be more preferably active component 0.05～0.2 gram, PEG400 or vegetable oil are the 0.05-0.3 gram; Particularly preferredly is active component 0.1-0.15 gram, PEG400 or vegetable oil are the 0.08-0.2 gram, and even with the mixture content of adjuvant by the principal agent of this ratio preparation, good fluidity is fit to pack into, and the soft capsule loading amount of preparation is accurate, even.
Contribution of the present invention is the extraction of active ingredients preparation in the soft capsule, and preparation method of the present invention is different with in the past preparation method, and Eupolyphaga Seu Steleophaga, Pyritum all need through the decoction effective component extracting in the method for the present invention.
The active component of soft capsule preparation of the present invention obtains by preparation method of the present invention, and this preparation method comprises the steps:
A. Radix Angelicae Sinensis extracts volatile oil; Or the medicinal residues water behind the extraction volatile oil decocts;
B. Pyritum decocts; Or the Pyritum water decocts the back precipitate with ethanol;
C. Eupolyphaga Seu Steleophaga decocts; Or Eupolyphaga Seu Steleophaga decocts back adding protease hydrolyzed; Or the Eupolyphaga Seu Steleophaga water decocts the back precipitate with ethanol
D. Radix Notoginseng, Olibanum are pulverized; Or Radix Notoginseng, Olibanum ethanol extraction;
E. Borneolum Syntheticum is pulverized;
Above step can merge in case of necessity, as is all when decocting boils and can decocts simultaneously, precipitate with ethanol simultaneously when being all precipitate with ethanol, and the product that above step obtains is combined by different combinations and is formed active constituents of medicine of the present invention.
Above preparation process can be formed the preparation method of three kinds of different active constituents of medicine of the present invention, and these three kinds of methods are:
Method one:
1. take by weighing Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g according to huoxue zhitong powder, huoxue zhitong san prescription ratio, standby;
2. Radix Angelicae Sinensis extracts volatile oil, the decocting liquid behind the extraction volatile oil, and being evaporated to relative density is 1.00-1.50, optimum density is 1.20 (50 ℃), and is standby;
3. Pyritum is decocted first, and medicinal residues and Eupolyphaga Seu Steleophaga, Pyritum decoct twice, and each 0.5-3 hour, it was 1 hour that Best Times decocts, and collecting decoction filters, and being evaporated to relative density is 1.00-1.50, and optimum density is 1.20 (50 ℃), and is standby;
4. ' 2 ' and ' 3 ' concentrated solution merges, add the ethanol precipitate with ethanol, concentration of alcohol is 75-90%, and best concentration of alcohol is 80%, get supernatant, it is 1.00-1.50 that recovery ethanol is evaporated to relative density, and optimum density is the clear paste of 1.18 (50 ℃), drying, pulverize, cross the 80-160 mesh sieve, the best results of sieving is 100 mesh sieves, and is standby;
5. Radix Notoginseng, Olibanum, Borneolum Syntheticum are pulverized, and cross the 80-160 mesh sieve, and the best results of sieving is 100 mesh sieves, and is standby;
6. get above each fine powder that makes, mix homogeneously, add volatile oil, obtain active component, through soft capsule preparation technology as the glycerol (the best is 5%), Polyethylene Glycol (this technology best be PEG400) or vegetable oil or the Cera Flava mix homogeneously that add 3%-6%, last encapsulating machine is made soft capsule, promptly.
Method two:
1. take by weighing Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g according to huoxue zhitong powder, huoxue zhitong san prescription ratio, standby;
2. Radix Angelicae Sinensis extracts volatile oil, collects standby;
3. Pyritum is decocted first, and medicinal residues and Eupolyphaga Seu Steleophaga, Pyritum decoct twice, each 1-3 hour, it is 1 hour that Best Times decocts, collecting decoction filters, and being evaporated to relative density is 1.00-1.50, optimum density is 1.20 (50 ℃), drying is pulverized, and crosses the 80-160 mesh sieve, the best results of sieving is 100 mesh sieves, and is standby;
4. Radix Notoginseng, Olibanum reclaim extracting solution with 50-75% ethanol extraction twice, reclaim ethanol, and being evaporated to relative density is 1.00-1.50, optimum density is the clear paste of 1.18 (50 ℃), and drying is pulverized, cross the 80-120 mesh sieve, the best results of sieving is 100 mesh sieves, and is standby;
5. Borneolum Syntheticum is pulverized, and crosses the 80-160 mesh sieve, and the best results of sieving is 100 mesh sieves, and is standby;
6. get above each fine powder that makes, mix homogeneously, add volatile oil, obtain active component, through soft capsule preparation technology as the glycerol (the best is 5%), Polyethylene Glycol (this technology best be PEG400) or vegetable oil or the Cera Flava mix homogeneously that add 3%-6%, last encapsulating machine is made soft capsule, promptly.
Method three:
1. take by weighing Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g according to huoxue zhitong powder, huoxue zhitong san prescription ratio, standby;
2. Radix Angelicae Sinensis extracts volatile oil, collects standby;
3. Pyritum is decocted first, and medicinal residues and Pyritum decoct twice, each 1-3 hour, it is 1 hour that Best Times decocts, collecting decoction filters, and being evaporated to relative density is 1.00-1.50, optimum density is 1.20 (50 ℃), drying is pulverized, and crosses the 80-160 mesh sieve, the best results of sieving is 100 mesh sieves, and is standby;
4. Radix Notoginseng, Olibanum reclaim extracting solution with 50-75% ethanol extraction twice, reclaim ethanol, and being evaporated to relative density is 1.00-1.50, optimum density is the clear paste of 1.18 (50 ℃), and drying is pulverized, cross the 80-120 mesh sieve, the best results of sieving is 100 mesh sieves, and is standby;
5. Borneolum Syntheticum is pulverized, and crosses the 80-120 mesh sieve, and the best results of sieving is 100 mesh sieves, and is standby;
6. Eupolyphaga Seu Steleophaga adds 5-10 times of water gaging, optimum water is 8 times, decocted 0.5-1.5 hour, Best Times is 0.5 hour, treat that temperature is reduced to 25-50 ℃ after, optimum temperature is 40 ℃, (10-11 ten thousand units/g), composite optium concentration is 0.4%, constantly stirs to add the neutral protease of 0.2%-0.4% at twice, each enzymolysis 1-4 hour, be warming up to 80-95 ℃ again, filter, be evaporated to relative density and be about 1.10-1.5, the best is the clear paste of 1.30 (50 ℃), drying under reduced pressure is pulverized, and crosses the 80-160 mesh sieve, the best is sieved and is 100 orders, and is standby;
7. get above each fine powder that makes, mix homogeneously adds volatile oil, adds glycerol (the best is 5%), Polyethylene Glycol (this technology is best to be PEG400) or vegetable oil or the Cera Flava mix homogeneously of 3%-6%, and last encapsulating machine is made soft capsule, promptly.
More than the medical material pulverized in three kinds of preparation methoies, can routine be ground into the 80-160 purpose fine powder of looking over so as to check, also can adopt super fine to be ground into 200-300 purpose fine powder.
More than the extraction of the contained volatile oil of Radix Angelicae Sinensis in three kinds of preparation methoies, can steam distillation, extraction such as supercritical extraction.
More than in three kinds of preparation methoies the drying of concentrated solution can adopt methods such as drying under reduced pressure, spray drying or vacuum drying.
The method for preparing soft capsule can adopt following steps:
1. the preparation of soft capsule rubber: get glycerol, water adds food coloring, grinds with colloid mill, make mix homogeneously, in the inputization glue jar, heating, add gelatin and stir, be heated to uniform temperature, insulation a period of time, evacuation stirs a period of time, till jar interior no bubble, cross 60 order filter clothes, insulation promptly gets the be complementary rubber solution of color of soft capsule and food coloring, and is standby;
2. compression moulding: start encapsulating machine, after preparing qualified rubber, carry out ball readjustment examination with liquid paraffin earlier, after treating that loading amount difference is qualified, the suspension of medicine and adjuvant is put into the liquid reservoir at machine top, elder generation's closing liquid paraffin inlet valve, open the medicine inlet valve again, the soft capsule that contains medicine is promptly suppressed and is finished, the soft capsule that elder generation extrudes, by " under an appendix I of Chinese pharmacopoeia version in 2000 the L item regulation of soft capsule content uniformity to soft capsule content carry out content uniformity claim fixed, qualified back start continuous production.The soft capsule that suppresses falls into the drum-type drying machine of making net bottom with thin copper wire, and molding in 10-12 hour does not stop to roll;
3. dry: as the soft capsule of forming to be loaded onto drying cart place in the hothouse that dehydrating unit is housed, regulate temperature, humidity, allow the interior moisture content of rubber slowly evaporate, and gently stir soft capsule every now and then, to prevent the adhesion of soft capsule pill, dry a period of time;
4. deoil, granulate, finished product: the soft capsule that drying is good is put into coating pan with the gauze of cleaning and is rolled, the gauze that rolls can absorb and clean the PEG400 and the liquid paraffin on soft capsule surface, qualified soft capsule cleans once with ethanol, to clean PEG400 and the liquid paraffin of soft capsule appearance remnants, qualified soft capsule, dry in dry sieve, check, packing promptly get the soft capsule finished product.
The dosage form of soft capsule of the present invention has following beneficial effect:
1. adopt each of above three kinds of preparation methoies, the promoting blood circulation and stopping pain soft capsule that makes is avoided the shortcoming of powder and hard capsule, and it is rapid to have a disintegrate, the bioavailability height, and good stability, good looking appearance, easy to carry, advantages such as taking convenience.
Promoting blood circulation and stopping pain soft capsule of the present invention is a natural medicine, has the effect of promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain, is mainly used in the treatment traumatic injury, swelling and pain due to blood stasis, by clinical verification, and can be applied to fracture, lumbago and skelalgia, scapulohumeral periarthritis, arthritis, deep swelling and pain due to blood stasis, cardio-cerebrovascular diseases.
Formulated new quality standard simultaneously, the quality standard of powder and hard capsule is changed and improved, respectively Radix Angelicae Sinensis, Radix Notoginseng, Borneolum Syntheticum have been carried out the qualitative investigation of TLC, chromatoplate is with CMC-Na silica gel G plate, all obtain satisfied result, and with this discriminating project as this product.Select for use ferulic acid in the Radix Angelicae Sinensis as quantitative target, adopt the HPLC method, carried out precision test, repeatability test, solvent stability test and application of sample recovery test respectively, method of proof is feasible, as the quantitative approach of preparation.
By the promoting blood circulation and stopping pain soft capsule that above preparation technology, moulding process and quality standard are produced, the product that becomes high in technological content, steady quality and be easy to control.
Promoting blood circulation and stopping pain soft capsule of the present invention experimental results show that its beneficial effect through following pharmacological toxicology:
1. maximum tolerated dose is 18g/kg, is equivalent to 831 times of the clinical consumption per day of 60kg people.
2. observe and repeat to give the promoting blood circulation and stopping pain soft capsule continuously, the at first symptom of Chu Xianing and the order of severity, the target organ of toxicity and recovery thereof and development the toxic reaction that rat produced.Rat continuous irrigation stomach gives promoting blood circulation and stopping pain soft capsule one month, observe body weight, the behavioral activity of rat, finish the back in administration and measure hematological indices, the blood parameters of rat and compare, simultaneously the rat main organs coefficient of comparative control group and administration group and carry out histopathologic slide's check.The phase of administration does not as a result see that rat behavior activity, the mental status are unusual to some extent, the equal steady growth of body weight; Each administration group hematology, blood parameters and matched group are not more also seen to be had obviously unusually; The pathological examination result does not show that the high dose group rat has internal organs generation pathological change yet.Do not observe rat and repeat to give the toxic reaction behind the promoting blood circulation and stopping pain soft capsule and the target organ of toxicity continuously.
3. promoting blood circulation and stopping pain soft capsule of the present invention has antiinflammatory action, can significantly suppress the granulomatous growth of mouse experiment, the early stage telangiectasis of inflammation, permeability increase, inflammatory material are oozed out and tissue edema, the antagonism of highly significant is arranged, effect is better than huoxue zhitong powder, huoxue zhitong san, the results are shown in Table 1-3.
The influence of table 1 promoting blood circulation and stopping pain soft capsule xylol induced mice auricle edema rate (
, n=11)
| Group | Dosage (g/kg) | Left side ear-auris dextra weight (mg) | Swelling rate (%) |
| Blank group prednisone group huoxue zhitong powder, huoxue zhitong san Huoxuezhitong Soft Capsule Huoxuezhitong Soft Capsule Huoxuezhitong Soft Capsule | Isometric(al) 0.0075 1.46 1.46 0.48 0.16 | 15.22±1.61 8.74±2.16 ** 13.6±2.91 10.4±2.00 ** 11.61±2.63 ** 15.75±4.69 | 96.42±17.77 53.39±11.71 ** 79.80±10.19 * 61.73±14.82 ** 70.26±16.14 ** 82.55±23.95 |
Annotate: compare with the normal saline group
*P＜0.05,
*P＜0.01; Compare with small dose group
ΔP＜0.05 (down together).
Table 2 promoting blood circulation and stopping pain soft capsule to the granulomatous influence of mouse experiment (
, n=11)
| Group | Dosage (g/kg) | Granuloma weight (mg) | Suppression ratio (%) |
| Blank group prednisone group huoxue zhitong powder, huoxue zhitong san promoting blood circulation and stopping pain soft capsule | Isometric(al) 0.0075 1.46 1.46 | 20.89±4.73 6.88±2.04 ** 14.82±4.24 * 7.67±2.39 ** | 100 33.0 71.0 36.7 |
| Promoting blood circulation and stopping pain soft capsule promoting blood circulation and stopping pain soft capsule | 0.48 0.16 | 8.08±2.00 ** 12.00±3.69 ** | 38.7 57.4 |
Table 3 promoting blood circulation and stopping pain soft capsule to the influence of mouse peritoneal capillary permeability (
, n=11)
| Group | Dosage (g/kg) | The blue amount of ivens (μ g/ml) |
| Blank group prednisone group huoxue zhitong powder, huoxue zhitong san Huoxuezhitong Soft Capsule Huoxuezhitong Soft Capsule Huoxuezhitong Soft Capsule | Isometric(al) 0.0075 1.46 1.46 0.48 0.16 | 1.68±0.29 1.12±0.16 ** 1.32±0.43 * 1.17±0.42 ** 1.18±0.63 * 1.63±0.41 |
4. the promoting blood circulation and stopping pain soft capsule can improve the pain threshold of electricity irritation afterbody mice, the results are shown in Table 4.
Table 4 promoting blood circulation and stopping pain soft capsule to the influence (tail electrostimulation) of the mice threshold of pain (
, n=10)
| Group | Dosage g/kg | Number of animals (n) | Before the medicine | Pain threshold after the administration (V) | |||
| 30min | 60min | 90min | 120min | ||||
| Blank group huoxue zhitong powder, huoxue zhitong san promoting blood circulation and stopping pain soft capsule promoting blood circulation and stopping pain soft capsule promoting blood circulation and stopping pain soft capsule | 1.46 1.46 0.48 0.16 | 9 10 10 10 10 | 20.1±1.3 20.5±1.6 20.5±1.6 20.5±2.8 21±2.1 | 20±4.3 25±4.7 * 31.5±5.8 ** 28.5±5.3 ** 28±5.9 ** | 21.7±2.5 29±3.9 ** 29.5±2.8 ** 27±3.5 ** 27.5±4.2 ** | 20.6±1.7 20.5±1.6 25±4.1 27.5±6.4 * 25±4.7 | 21.1±2.2 22±2.6 21.5±2.4 22.5±3.5 21.5±2.4 |
Compare with normal group
*P＜0.05,
*P＜0.01.
5. promoting blood circulation and stopping pain soft capsule of the present invention can improve hemorheological property and microcirculation.Rat whole blood viscosity, plasma viscosity, platelet aggregation rate and external thrombus that percutaneous is injected adrenalin hydrochloride and ice-water bath modeling down form all obviously increase, and the promoting blood circulation and stopping pain soft capsule can obviously reduce whole blood viscosity, the plasma viscosity of " syndrome of blood stasis " rat model, and can suppress hematoblastic gathering and external thrombus formation.Effect is better than huoxue zhitong powder, huoxue zhitong san, the results are shown in Table 5-6.
Table 5 promoting blood circulation and stopping pain soft capsule is to the influence of " syndrome of blood stasis " rat whole blood and plasma viscosity
| Group | The dosage number | Animal | Whole blood viscosity | Plasma viscosity (1.0s-1) | (g/kg) (100.0s-1) | ||
| (200.0s -1) | 60.0s -1) | (5.0s -1) | |||||
| Blank model group Radix Salviae Miltiorrhizae group powder promoting blood circulation and stopping pain soft capsule | Isometric(al) isometric(al) 1.0 0.78 1.10 0.36 | 11 12 11 11 11 11 | 3.88±0.47 ** 5.00±0.68 4.36±0.48 * 4.91±0.48 4.61±0.34 4.62±0.39 | 4.77±0.42 ** 6.41±1.02 5.18±0.64 ** 5.85±0.54 5.59±0.54 * 5.46±0.43 * | 10.00±0.99 ** 13.63±2.16 *10.34±1.71 ** 12.20±1.75 10.92±1.35 ** 11.41±1.06 ** | 23.43±3.59 ** 35.61±5.68 24.61±5.51 ** 27.99±5.53 ** 26.81±4.48 ** 26.54±2.62 ** | 1.39±0.17 ** 1.83±0.20 1.52±0.20 ** 1.54±0.20 ** 1.62±0.17 * 1.57±0.15 ** |
| 0.12 | 11 | 4.93±0.49 | 5.88±0.56 | 12.48±1.54 | 29.88±4.99 * | 1.66±0.16 * |
Annotate: compare with model group
*P＜0.05,
*P＜0.01; Compare with small dose group
ΔP＜0.05,
The Δ ΔP＜0.01.
Table 6 promoting blood circulation and stopping pain soft capsule is to the influence of " syndrome of blood stasis " rat platelet aggregation rate
| Group | Dosage (g/kg) | Number of animals | 1min aggregation rate (%) | Maximum agglutination rate (%) | 5min aggregation rate (%) |
| Blank model group Radix Salviae Miltiorrhizae group powder promoting blood circulation and stopping pain soft capsule | Isometric(al) isometric(al) 1.0 0.78 1.10 0.36 0.12 | 11 12 11 11 11 11 11 | 19.22±8.99 ** 41.59±20.86 17.70±5.23 ** 30.78±12.98 18.58±10.9 ** 23.83±9.28 * 24.66±13.88 * | 28.42±11.14 * 50.25±25.32 22.99±11.82 ** 43.18±17.63 22.86±13.54 ** 29.63±13.02 * 30.11±16.90 * | 20.51±12.58 36.09±31.40 14.65±12.59 * 34.51±19.75 13.33±12.99* 18.68±15.80 13.14±11.55 * |
Annotate: compare with model group
*P＜0.05,
*P＜0.01; Compare with small dose group
ΔP＜0.05,
The Δ ΔP＜0.01.
6. the experiment of Mice Auricle microcirculation shows, promoting blood circulation and stopping pain soft capsule height, middle dosage have the caliber that increases diameter of normal mouse auricula arteriole, venule, accelerates the effect of microcirculation blood flow velocity.Effect is better than huoxue zhitong powder, huoxue zhitong san.
So the promoting blood circulation and stopping pain soft capsule by above preparation technology, moulding process and quality standard production has efficiently, the good product of safe without toxic side effect.
The specific embodiment:
Further specify the present invention by the following examples.
Embodiment 1
Prescription:
Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g.
Radix Angelicae Sinensis extracts volatile oil, the decocting liquid behind the extraction volatile oil, and being evaporated to relative density is 1.00-1.50, optimum density is 1.20 (50 ℃), and is standby;
Pyritum is decocted first, and medicinal residues and Eupolyphaga Seu Steleophaga, Pyritum decoct twice, and each 1 hour, collecting decoction filters, and is evaporated to relative density and is 1.20 (50 ℃), and was standby;
Above-mentioned concentrated solution merges, and adds the ethanol precipitate with ethanol, and concentration of alcohol is 80%, gets supernatant, reclaims ethanol and is evaporated to the clear paste that relative density is 1.18 (50 ℃), and drying is pulverized, and crosses 100 mesh sieves, and is standby;
Radix Notoginseng, Olibanum, Borneolum Syntheticum are pulverized, and cross 100 mesh sieves, and be standby;
Get above each fine powder that makes, mix homogeneously adds volatile oil, obtains active component, through soft capsule preparation technology as: add 5% glycerol, mix homogeneously, last encapsulating machine is made soft capsule, promptly.
Embodiment 2
Prescription:
Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g.
Radix Angelicae Sinensis extracts volatile oil, collects standby;
Pyritum is decocted first, and medicinal residues and Eupolyphaga Seu Steleophaga, Pyritum decoct twice, and each 1 hour, collecting decoction filtered, and being evaporated to relative density is 1.20 (50 ℃), and drying is pulverized, and 100 mesh sieves are standby;
Radix Notoginseng, Olibanum reclaim extracting solution with 75% ethanol extraction twice, reclaim ethanol, and being evaporated to relative density is the clear paste of 1.18 (50 ℃), and drying is pulverized, and crosses 100 mesh sieves, and is standby;
Borneolum Syntheticum is pulverized, and crosses 100 mesh sieves, and is standby;
Get above each fine powder that makes, mix homogeneously adds volatile oil, obtains active component, through soft capsule preparation technology as: it is even to add 5% glycerol, and last encapsulating machine is made soft capsule, promptly.
Embodiment 3
Prescription:
Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (system) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (forging) 120g.
Radix Angelicae Sinensis extracts volatile oil, collects standby;
Pyritum is decocted first, and medicinal residues and Pyritum decoct twice, and each 1 hour, collecting decoction filtered, and being evaporated to relative density is 1.20 (50 ℃), and drying is pulverized, and crosses 100 mesh sieves, and is standby;
Radix Notoginseng, Olibanum reclaim extracting solution with 50% ethanol extraction twice, reclaim ethanol, and being evaporated to relative density is the clear paste of 1.18 (50 ℃), and drying is pulverized, and crosses 100 mesh sieves, and is standby;
Borneolum Syntheticum is pulverized, and crosses 100 mesh sieves, and is standby;
Eupolyphaga Seu Steleophaga adds 8 times of water gagings, decocts 0.5 hour, treat that temperature is reduced to 40 ℃ after, add 0.4% neutral protease (10-11 ten thousand units/g) at twice, constantly stir, each enzymolysis 3 hours is warming up to 80-95 ℃ again, filter, be evaporated to relative density and be about the clear paste of 1.30 (50 ℃), drying under reduced pressure is pulverized, cross 100 mesh sieves, standby;
Get above each fine powder that makes, mix homogeneously adds volatile oil, adds 5% vegetable oil mix homogeneously, and last encapsulating machine is made soft capsule, promptly.
Claims (10)
1. promoting blood circulation and stopping pain soft capsule preparation, form by soft capsule shell and content, active constituents of medicine and pharmaceutic adjuvant that soft capsule content is made by Radix Angelicae Sinensis, Radix Notoginseng, Olibanum (processed), Borneolum Syntheticum, Eupolyphaga Seu Steleophaga, Pyritum (calcined) are formed, and described pharmaceutic adjuvant is selected from PEG400, glycerol, vegetable oil or Cera Flava.
2. soft capsule preparation according to claim 1, the active constituents of medicine in per 1000 soft capsules is made up of Radix Angelicae Sinensis 400g, Radix Notoginseng 80g, Olibanum (processed) 80g, Borneolum Syntheticum 20g, Eupolyphaga Seu Steleophaga 200g, Pyritum (calcined) 120g.
3. according to each described soft capsule preparation of claim 1-2, it is characterized in that active constituents of medicine is 1 with the ratio of the weight of pharmaceutic adjuvant: 0.5-1: 5.
4. the preparation method of the described soft capsule preparation Chinese medicine of claim 1 active component comprises Radix Angelicae Sinensis, Radix Notoginseng, Olibanum (processed), Borneolum Syntheticum, Eupolyphaga Seu Steleophaga, Pyritum (calcined) is extracted processing, it is characterized in that the process following steps:
A. Radix Angelicae Sinensis extracts volatile oil; Or the medicinal residues water behind the extraction volatile oil decocts;
B. Pyritum (calcined) decocts; Or the Pyritum (calcined) water decocts the back precipitate with ethanol;
C. Eupolyphaga Seu Steleophaga decocts; Or Eupolyphaga Seu Steleophaga decocts back adding protease hydrolyzed; Or the Eupolyphaga Seu Steleophaga water decocts the back precipitate with ethanol;
D. Radix Notoginseng, Olibanum (processed) are pulverized; Or Radix Notoginseng, Olibanum (processed) ethanol extraction;
E. Borneolum Syntheticum is pulverized; Or merge same operation in the above step.
5. the preparation method of the described soft capsule preparation Chinese medicine of claim 1 active component is characterized in that, the process following steps:
A. Radix Angelicae Sinensis extracts volatile oil;
B. the Radix Angelicae Sinensis medicinal residues water that extracts behind the volatile oil decocts; Pyritum (calcined) decocts; Eupolyphaga Seu Steleophaga decocts;
The decoction liquor that the c.b step obtains concentrates the back precipitate with ethanol;
D. Radix Notoginseng, Olibanum (processed), Borneolum Syntheticum are pulverized.
6. the preparation method of the described soft capsule preparation Chinese medicine of claim 1 active component is characterized in that, the process following steps:
A. Radix Angelicae Sinensis extracts volatile oil;
B. medicinal residues, Pyritum (calcined), the Eupolyphaga Seu Steleophaga behind the Radix Angelicae Sinensis extraction volatile oil decocts;
C. Radix Notoginseng, Olibanum (processed) ethanol extraction;
D. Borneolum Syntheticum is pulverized.
7. the preparation method of the described soft capsule preparation Chinese medicine of claim 1 active component is characterized in that,
The process following steps:
A. Radix Angelicae Sinensis extracts volatile oil;
B. medicinal residues, the Pyritum (calcined) behind the Radix Angelicae Sinensis extraction volatile oil decocts;
C. Eupolyphaga Seu Steleophaga decocts back adding protease hydrolyzed;
D. Radix Notoginseng, Olibanum (processed) ethanol extraction;
E. Borneolum Syntheticum is pulverized.
8. the preparation method of a promoting blood circulation and stopping pain soft capsule preparation comprises that the active constituents of medicine that each method of claim 4-7 is made mixes with pharmaceutic adjuvant.
9. preparation method according to claim 8, described pharmaceutic adjuvant is selected from PEG400, glycerol, vegetable oil or Cera Flava.
10. each described soft capsule preparation of claim 1-3 is used for preparing a kind of application with medicine that is used for the treatment of traumatic injury, swelling and pain due to blood stasis, fracture, lumbago and skelalgia, scapulohumeral periarthritis, arthritis, deep swelling and pain due to blood stasis or cardiovascular and cerebrovascular disease of promoting blood circulation to remove blood stasis, reducing swelling and alleviating pain effect.
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Non-Patent Citations (2)
| Title |
|---|
| 中华人民共和国药典 国家药典委员会，538，539，化学工业出版社 2000 * |
| 中药药剂学 349，上海科学计算出版社 2003 * |
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