CN101612353A - A kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof - Google Patents
A kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of XINNAOKANG soft capsule and preparation method thereof.This XINNAOKANG soft capsule preparation method is that except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 100 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix, drying is crushed to 150 orders, sieves, and adds the Cor Cervi powder, and mixing with the ratio adding fine drug powder of vegetable oil according to 2: 1, adds 3% Cera Flava mix homogeneously again, makes soft capsule.Clinical trial proves that this soft capsule all has significance to improve than the curative effect and the bioavailability of original capsule agent.
Description
Technical field
The present invention relates to a kind of Chinese medicine for the treatment of cardiovascular and cerebrovascular disease, particularly, the present invention relates to a kind of Chinese medicine composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof.
Background technology
Along with the raising of social life level and the aging of population, the sickness rate of cardiovascular disease presents the trend of rapid rising.Especially coronary heart disease, the healthy of middle-aged and elderly people in the serious threat of angina pectoris and cerebral arteriosclerosis, and is affected the orthobiosis of many middle-aged and elderly people, also brought many miseries to family simultaneously.
Because this class disease incidence crowd is wide, the course of disease is long, cure rate is low, the medicine that is used for the treatment of this type of disease now is a lot, and its therapeutic effect also is uneven, and the most of side effect of Western medicine is more, and price is higher, so select a kind of having no side effect, determined curative effect, the medicine that price is suitable offers the patient very important meaning.By relatively finding, XINNAOKANG JIAONANG is the relatively more significant medicine of a kind of curative effect, its standard derives from the 13 of ministry standard " XINNAOKANG JIAONANG ", form by ten Six-element crude drug such as Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Puerariae, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Pheretima, Radix Curcumae, Radix Polygalae (processed with honey), Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae (stir-fry), Cor Cervi powder, Radix Glycyrrhizaes, preparation method is, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into fine powder, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes decoct with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, and filtrate is condensed into cream.Add above-mentioned fine powder, mix, drying is pulverized, and sieves, and adds the Cor Cervi powder, and mixing incapsulates, promptly.But its preparation technology also is unfavorable for the abundant extraction stripping of active ingredient and the saving of the energy, and the capsule that makes and be unfavorable for effective ingredient quick dissolving and absorption in vivo, bioavailability is not high, can not reach cardiovascular and cerebrovascular disease medication requirement fast and efficiently.Become the technical problem that this area need solve so how to improve the quality of this medicament and increase production efficiency, provide a kind of and can give full play to this curative effect of medication, the reasonable dosage form that can take effect fast has very important meaning.
Summary of the invention
For quality and the increase production efficiency of improving the XINNAOKANG JIAONANG agent, improve the curative effect of product.The invention provides following technical proposals:
The XINNAOKANG soft capsule preparation is to be prepared from according to following steps:
Step 1: weighting raw materials Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g;
Step 2: ten Six-element crude drug in the step 1, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into fine powder, sieve, and be standby;
Step 3: all the other Radix Salviae Miltiorrhizaes, Radix Paeoniae Rubra, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Puerariae, Pheretima 6 flavors, with dynamic continuous countercurrent extraction method using extracting in water, filter, filtrate is condensed into thick paste;
Step 3: all the other Radix Salviae Miltiorrhizaes, Radix Paeoniae Rubra, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Puerariae, Pheretima 6 flavors, with dynamic continuous countercurrent extraction method using extracting in water, filter, filtrate is condensed into thick paste;
Step 4: with adding step 2 gained fine powder in the step 3 gained thick paste, mix, drying is pulverized, and sieves, and adds the Cor Cervi powder again, and mixing adds fine drug powder in the disperse medium, adds an amount of suspensoid mix homogeneously again, is pressed into soft capsule.
Add 4～6 times of water gagings when extracting with dynamic continuous countercurrent extraction method using in the above-mentioned steps 3 and extracted 1～3 hour, extracting solution filters, and relative density was 1.20～1.35 thick paste when filtrate was concentrated into 50 ℃.
The granularity of above-mentioned steps 1 Chinese medicine fine powder is 80～120 orders, and the smashing fineness of step 4 Chinese medicine is 100～200 orders.
Disperse medium can be PEG400 or vegetable oil in the above-mentioned steps 4; Suspending agent can be 1%～5% PEG4000 or 6000, Cera Flava, aluminum monostearate or ethyl cellulose.
Above-mentioned steps 4 Chinese medicine powders and the blended ratio of disperse medium are 1～8: 1～8.
The step of compacting soft capsule grain is molding 2～4 hours in the drum-type make-up machine in the above-mentioned steps 4, condition of molding is 25～30 ℃ of temperature, relative humidity 15～25%, wash ball, put to dry in the air in the dish that dries in the air and put dry 15～30 hours then with 90～99% ethanol then, 20～30 ℃ of drying conditions, humidity 15～25%.
XINNAOKANG soft capsule preparation method is preferably:
Get Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 100 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 150 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 2: 1, adds 3% Cera Flava mix homogeneously again, molding is 3 hours in the drum-type make-up machine, and condition of molding is 27 ℃ of temperature, relative humidity 20%, wash ball, put to dry in the air in the dish that dries in the air and put dry 24 hours then with 95% ethanol then, 26 ℃ of drying conditions, humidity 20% promptly gets soft capsule.
The XINNAOKANG soft capsule preparation that we invented has not only overcome the shortcoming of hard capsule, medicine is present in the disperse medium with the suspendible shape, its enhanced dissolution rate, bioavailability improve, better efficacy, and soft capsule is easy to swallow and outward appearance is beautiful, more easy for patients to accept.By pharmacodynamics test and clinical trial, prove that it is evident in efficacy, instant effect, the cure rate height can effectively be treated coronary heart disease, and angina pectoris and cerebral arteriosclerosis have significant difference with its curative effect of XINNAOKANG JIAONANG comparison.
The specific embodiment
The process test research of [test example 1] medicine of the present invention
1, the selection of extraction process by water
We use the influence of different water extracting methods to the medicine effective component content by measuring paeoniflorin content in the water extract to investigate, and concrete grammar is as follows:
We take by weighing totally 6 parts of 6 flavor medical materials such as Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Radix Polygoni Multiflori, Fructus Lycii, Radix Puerariae, Pheretima in proportion, are divided into 2 groups, and first group of employing decocts with water three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time; Second group is adopted dynamic continuous countercurrent extraction method using, adds 4 times of water gagings, decocts 2 hours.By investigating paeoniflorin content in the dry extract, to determine the advance of selected technology.The results are shown in following table:
Table 1: Different Extraction Method dry extract paeoniflorin content
As can be seen from the above table, dynamically the paeoniflorin content of Continuous Countercurrent Extraction group boils group apparently higher than decocting.Dynamically Continuous Countercurrent Extraction is to utilize the biphase Concentraton gradient of solid-liquid poor, step by step effective ingredient in the spice is diffused to the relatively low cover of initial concentration and carries in the solution, reaches the purpose that shifts solvent components in the material to greatest extent.The application of this process for extracting makes the active ingredient extraction rate of medicine improve greatly, has not only improved the curative effect of medicine, and saves the energy, extraction efficiency height.
2, the investigation of medicine smashing fineness and adding disperse medium ratio
When filling solid drugs in the soft capsule, drug powder requires to pass through sieve No. five, and mix homogeneously.Among the present invention with the medicinal mixture pulverize separately to different fineness, get equivalent and add different disperse medium mix homogeneously.Determine the fineness that medicine is pulverized by the uniformity of investigating the soft capsule liquid after 2 hours.The results are shown in following table:
Table 2: medicine smashing fineness and the investigation result who adds the disperse medium mixing homogeneity
By last table as can be seen, grinding particle size is when 80～120 orders, and the capsule liquid uniformity is bad, and the layering and precipitating phenomenon can appear in medicine.Grinding particle size in 120～150 order capsule liquid stability better lamination do not occur at the appointed time; The medicine smashing fineness is more than 150 orders, and when mixing with disperse medium, not only energy consumption increases, and the medicine proportion of goods damageds when pulverizing, dust pollution increases, and is 120～150 orders so select grinding particle size.
3, the screening experiment of soft capsule shell proportioning raw materials ratio
We select gelatin, glycerol, the water of different proportion to make softgel shell, the capsule liquid that method for optimizing is mixed with is pressed into soft capsule with the softgel shell of different proportionings, by investigating softgel shell elasticity, hygroscopicity, disintegration time, determine the ratio of gelatin, glycerol, water, the results are shown in following table:
Table 3: the soft capsule shell proportioning is investigated the result
| Gelatin: glycerol: water | Elasticity | Hygroscopicity | Disintegration time |
| ??????1∶0.3∶0.9 | Harder | Moisture absorption | 56 minutes |
| ??????1∶0.4∶1.2 | Moderate | Non-hygroscopic | 34 minutes |
| ??????1∶0.5∶1.4 | Softer | Non-hygroscopic | 21 minutes |
| ??????1∶0.6∶1.5 | Soft | Non-hygroscopic | 18 minutes |
From last table result as can be seen, the proportioning of gelatin, glycerol, water is 1: 0.4: 1.2 o'clock, and the every index of the soft capsule shell that makes is all good.
3, with the qualification rate of making soft capsule and respectively test gained qualified products human body to take the blood drug level of back 2h serve as to investigate foundation, adopt orthogonal test that disperse medium, suspending agent, medicine and disperse medium ratio are studied, concrete grammar is as follows:
Get 9 parts of medicine crude drugs of the present invention, extract medicine, pulverizing, preparation softgel shell according to above-mentioned optimization test method, according to orthogonal table L
9(3
4) arrange test, the preparation soft capsule is investigated the blood drug level that the qualification rate that makes soft capsule and human body take back 2h (to test the blood drug level that 1 gained soft capsule records when the 2h is reference numerical value, calculates and respectively organizes blood drug level and its ratio), the results are shown in following table:
The preferred factor level table of table 4.
Table 5. factor screening orthogonal experiment data table
Table 6. soft capsule qualification rate analysis of variance table
The variance analysis of table 7 soft capsule blood drug level ratio
Show that by extreme difference R value size in the table 5 each factor effect primary and secondary is A＞C＞B; Intuitive analysis is with A
1B
1C
2Be optimised process; Shown by table 6,7 The results of analysis of variance: the influence of A, C factor has the significance meaning, and the influence of B factor does not have the significance meaning.That is: disperse medium is a vegetable oil, and the ratio of medicine and disperse medium is 1: 2, and when suspending agent was 3% Cera Flava, obtained soft capsule yield rate is the highest, and was best in bioavailability.
The pharmacodynamics test research of [test example 2] medicine of the present invention
Supply the reagent thing: according to the prepared soft capsule of the present invention [embodiment 1].
The positive control medicine: XINNAOKANG JIAONANG, produce lot number 06052001 by the Beijing Yadong Biology Pharmacy Co., Ltd
170 of animal Wistar rats, male and female have concurrently.Available from Institute of Genetics, Academia Sinica's Experimental Animal Center, the quality certification number: DB07/034.2-93
Thrombosis instrument, VZS-723 spectrophotometer, PAT-4A type platelet aggregation instrument, R80 blood viscosity instrument in the instrument experiment gonosome.
Method and result
(1) medicine of the present invention Chinese People's Anti-Japanese Military and Political College Mus carotid artery thrombosis experiment
40 of Wistar male rats, body weight (232 ± 21) g.Be divided into 4 groups at random, the heavy dose of group of medicine promptly of the present invention 0.56g/kg, small dose group 0.38g/kg, positive control drug XINNAOKANG JIAONANG group 0.38g/kg and blank group, 10 every group.Gastric infusion.Every day 1 time, successive administration 5 days.The administration volume is 2ml/200g.Matched group gives isometric normal saline.1.5h begins experiment after the last administration.Rat is through 2.5% pentobarbital sodium intraperitoneal anesthesia, separate right carotid, adopting electrical injuries carotid artery intima method to place electrode on tremulous pulse carries out electricity irritation (2mA, 7min), record begins to thrombus formation time (above 50min in 50min) from electricity irritation.The result sees table 8 for details
Table 8 medicine of the present invention is to the thrombotic influence of rat carotid artery
Compare * P＜0.05, * * P＜0.01 with matched group; Compare △＜0.05 with XINNAOKANG JIAONANG
The result shows: the large and small dosage of medicine of the present invention all can obviously prolong the formation of mice body arteria carotis interna thrombosis.The medicine of the present invention of same dose is compared with XINNAOKANG JIAONANG has significant difference; Medicine escalated dose of the present invention suppresses thrombus formation time and prolongs.
(2) medicine of the present invention is to the influence of rat cerebral tissue's capillary permeability
50 of Wistar rats, body weight (215 ± 26) g, male and female half and half.Be divided into 5 groups at random, the heavy dose of group of medicine promptly of the present invention 0.75g/kg, small dose group 0.375g/kg, positive control medicine XINNAOKANG JIAONANG group 0.375g/kg, cerebral ischemic model group and sham operated rats, 10 every group.Gastric infusion.Every day 1 time, successive administration 5 days.The administration volume is 2ml/200g.Sham operated rats and cerebral ischemic model group give isopyknic normal saline.1.5h begins experiment after the last administration.Animal is with 25% urethane (1g/kg) intraperitoneal anesthesia.The cervical region median incision separates bilateral carotid, and threading is standby.Ischemia model group and each drug study group then before the ligation bilateral carotid 5min by tail vein injection azovan blue 50mg/kg.Sham operated rats is identical with each experimental group with model group wants seeking time tail vein injection azovan blue 50mg/kg, but not ligation bilateral carotid.Behind the ligation 3h, broken end is got brain and is weighed, and is soaked in formamide solution respectively in (4ml/ brain), incubation 72h in 45 ℃ of calorstats, treat that the azovan blue pigment all leaches in the cerebral tissue, get and contain the azovan blue pigment solution and carry out colorimetric, measure the OD value in VZS-723 spectrophotometer 620nm place.The result sees table 9 for details
Table 9 medicine of the present invention is to the influence of rat cerebral tissue's capillary permeability
Compare * P＜0.05, * * P＜0.01 with sham operated rats; Compare △ P＜0.05, △ △ P＜0.01 with model group;
Compare zero P＜0.01 with positive controls
The result shows: medicine of the present invention can obviously improve the capillary permeability that cerebral ischemia causes, compares with the matched group XINNAOKANG JIAONANG, has significant difference.Dosage strengthens capillary permeability is strengthened.
(3) medicine of the present invention is to the influence of rat platelet aggregation function
40 of Wistar rats, body weight (228 ± 19) g, male and female half and half.Be divided into 4 groups at random, the heavy dose of group of medicine promptly of the present invention 0.75g/kg, small dose group 0.375g/kg, positive control drug XINNAOKANG JIAONANG group 0.375g/kg and blank group, 10 every group.Gastric infusion.Every day 1 time, successive administration 5 days.The administration volume is 2ml/200g.Matched group gives isometric normal saline.1.5h begins experiment after the last administration.From jugular vein get blood 2.5ml put into add 3.8% sodium citrate in vitro (with the ratio of blood be 1: 9), seal mixing.With the centrifugal 10min of 1000r/min, isolate platelet rich plasma (PRP); With the centrifugal 30min of 3000r/min, isolate platelet poor plasma (PPP), the inductive platelet aggregation of ADP is measured, and calculated maximum agglutination rate, gathering suppression ratio and 5min depolymerization rate.The result sees table 10 for details
Table 10 medicine of the present invention is to the influence of rat platelet aggregation function
| Group | Dosage (g/kg) | Maximum agglutination rate (%) | 5min aggregation rate (%) |
| The blank group | ??- | ??64.57±10.89 | ??51.38±9.04 |
| XINNAOKANG JIAONANG | ??0.38 | ??50.73±15.69 | ??39.72±17.38* |
| Medicine of the present invention (little) | ??0.38 | ??43.58±12.04 | ??33.58±15.09*△ |
| Medicine of the present invention (greatly) | ??0.56 | ??41.14±15.46 | ??30.46±20.28** ??△ |
Compare * P＜0.05, * * P＜0.01 with the blank group; Compare △ P＜0.01 with XINNAOKANG JIAONANG.
The result shows: medicine of the present invention has the obvious suppression effect to the inductive rat platelet aggregation of ADP, compares with the control drug XINNAOKANG JIAONANG to have significant difference, and escalated dose strengthens hematoblastic inhibitory action.
(4) the inductive rat platelet aggregation of ADP there is obvious inhibitory action
Medicine of the present invention influences 40 of Wistar male rats, body weight (231 ± 25) g to the rat blood viscosity.Be divided into 4 groups at random, 10 every group.Gastric infusion.Every day 1 time, successive administration 5 days.The administration volume is 2ml/200g.Matched group gives isometric normal saline.1.5h measures blood viscosity from the jugular vein 2ml (anticoagulant) that takes a blood sample with R80 blood viscosity instrument after the last administration.The result sees table 11 for details
Table 11 medicine of the present invention is to the influence of rat blood viscosity
| Group | Dosage (g/ kg) | The whole blood viscosity height is cut | Whole blood viscosity is low cuts | The blood plasma viscosity | Erythrocyte aggregation index | Packed cell volume |
| The blank group | ??- | ??4.93± ??1.24 | ??18.60±2.74 | ??2.30± ??0.16 | ??4.48±0.41 | ??58.33± ??2.71 |
| XINNAOKANG JIAONANG | ??0.38 | ??3.98± ??0.56* | ??16.82±2.78 ??* | ??1.73± ??0.13* | ??3.91±0.37 ??* | ??48.88± ??1.75* |
| Medicine of the present invention (little) | ??0.38 | ??3.96± ??0.76*△ | ??14.79± ??3.13*△ | ??1.20± ??0.14*△ | ??3.31±0.39 ??*△ | ??43.12± ??1.95*△ |
| Medicine of the present invention (greatly) | ??0.56 | ??3.01± ??0.59**△ | ??13.58± ??2.36**△ | ??1.11± ??0.14**△ | ??3.25± ??0.16**△ | ??41.64± ??1.78**△ |
Compare * P＜0.05, * * P＜0.01 with the blank group; Compare △ P＜0.05 with XINNAOKANG JIAONANG
The result shows: medicine of the present invention can significantly reduce rat whole blood viscosity, blood plasma viscosity, packed cell volume and erythrocyte aggregation index, has compared significant difference with the control drug XINNAOKANG JIAONANG, and escalated dose reduces every index and increases.
The clinical observation on the therapeutic effect test of [test example 3] soft capsule treatment cardiovascular and cerebrovascular disease of the present invention
The observation of curative effect of clinical practice XINNAOKANG soft capsule is observed angina pectoris and cerebral arteriosclerosis card patient 540 examples, wherein treatment group (according to the soft capsule of embodiment 1 preparation) 300 examples, matched group (XINNAOKANG JIAONANG) 180 examples, non-controlled trial group 60 examples.
(1) to the improvement of angina pectoris and cerebral arteriosclerosis card
Table 12: respectively organize angina pectoris and cerebral arteriosclerosis card curative effect before and after the treatment relatively
| Group | ??N | Before the treatment | After the treatment | Disappear (routine number) |
| The treatment group | ?120 | ??115 | ??11 | ??104**△ |
| Matched group | ?60 | ??55 | ??29 | ??26* |
| Non-control experiment group | ?60 | ??58 | ??41 | ??17 |
Compare * P＜0.05, * * P＜0.01 with non-control experiment group; Compare △ P＜0.05 with matched group
This product and XINNAOKANG JIAONANG relatively have obvious effect to angina pectoris and cerebral arteriosclerosis card as seen from table.
(2) different pathological clinical efficacy in period relatively
Table 13: different stadium total effectses relatively
* treatment group and matched group be P＜0.05 relatively
Show by last table no matter acute stage is still recovered in early days, treatment group curative effect all is better than matched group.
Observe conclusion
By clinical test results as can be seen, medicine of the present invention is to treatment coronary heart disease, angina pectoris and cerebral arteriosclerosis have significant curative effect, and clinical effectiveness is significantly higher than capsule, illustrate that this novel pharmaceutical formulation given full play to the curative effect of this pharmaceutical composition, the medicine of not only a kind of efficient, safety is arranged, price is suitable for the treatment cardiovascular and cerebrovascular disease provides, and the medicine that further proves the treatment by Chinese herbs cardiovascular and cerebrovascular disease can make its curative effect that huge raising takes place under the application of reasonable dosage form.
Following examples all can realize the routine described effect of above test
[embodiment 1] gets Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 100 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 150 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 2: 1, adds 3% Cera Flava mix homogeneously again, molding is 3 hours in the drum-type make-up machine, and condition of molding is 27 ℃ of temperature, relative humidity 20%, wash ball, put to dry in the air in the dish that dries in the air and put dry 24 hours then with 95% ethanol then, 26 ℃ of drying conditions, humidity 20% promptly gets soft capsule.
[embodiment 2] get Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 100 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 150 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 3: 2, adds 3% Cera Flava mix homogeneously again, molding is 3 hours in the drum-type make-up machine, and condition of molding is 27 ℃ of temperature, relative humidity 20%, wash ball, put to dry in the air in the dish that dries in the air and put dry 24 hours then with 95% ethanol then, 26 ℃ of drying conditions, humidity 20% promptly gets soft capsule.
[embodiment 3] get Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 100 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 150 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 2: 2, adds 3% Cera Flava mix homogeneously again, molding is 3 hours in the drum-type make-up machine, and condition of molding is 27 ℃ of temperature, relative humidity 20%, wash ball, put to dry in the air in the dish that dries in the air and put dry 24 hours then with 95% ethanol then, 26 ℃ of drying conditions, humidity 20% promptly gets soft capsule.
[embodiment 4] get Radix Salviae Miltiorrhizae 60g, Radix Paeoniae Rubra 45g, Radix Polygoni Multiflori Preparata 45g, Fructus Lycii 45g, Radix Puerariae 45g, Rhizoma Chuanxiong 45g, Flos Carthami 30g, Rhizoma Alismatis 45g, Radix Achyranthis Bidentatae 45g, Pheretima 45g, Radix Curcumae 4.5g, Radix Polygalae (processed with honey) 45g, Rhizoma Anemones Altaicae 45g, Semen Ziziphi Spinosae (stir-fry) 30g, Cor Cervi powder 45g, Radix Glycyrrhizae 30g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 80 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 6 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.35 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 100 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 2: 1, adds 5% Cera Flava mix homogeneously again, molding is 4 hours in the drum-type make-up machine, and condition of molding is 25 ℃ of temperature, relative humidity 15%, wash ball, put to dry in the air in the dish that dries in the air and put dry 20 hours then with 90% ethanol then, 30 ℃ of drying conditions, humidity 25% promptly gets soft capsule.
[embodiment 5] get Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 120 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 3 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 200 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 2: 1, adds 1% Cera Flava mix homogeneously again, molding is 2 hours in the drum-type make-up machine, and condition of molding is 30 ℃ of temperature, relative humidity 25%, wash ball, put to dry in the air in the dish that dries in the air and put dry 30 hours then with 99% ethanol then, 20 ℃ of drying conditions, humidity 15% promptly gets soft capsule.
Claims (7)
1, a kind of XINNAOKANG soft capsule preparation is characterized in that this soft capsule is prepared from according to following steps:
Step 1: weighting raw materials Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g;
Step 2: ten Six-element crude drug in the step 1, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into fine powder, sieve, and be standby;
Step 3: all the other Radix Salviae Miltiorrhizaes, Radix Paeoniae Rubra, Radix Polygoni Multiflori Preparata, Fructus Lycii, Radix Puerariae, Pheretima 6 flavors, with dynamic continuous countercurrent extraction method using extracting in water, filter, filtrate is condensed into thick paste;
Step 4: with adding step 2 gained fine powder in the step 3 gained thick paste, mix, drying is pulverized, and sieves, and adds the Cor Cervi powder again, and mixing adds fine drug powder in the disperse medium, adds an amount of suspensoid mix homogeneously again, is pressed into soft capsule.
2, according to the described soft capsule preparation of claim 1, add 4～6 times of water gagings when it is characterized in that in the step 3 extracting and extracted 1～3 hour with dynamic continuous countercurrent extraction method using, extracting solution filters, and relative density was 1.20～1.35 thick paste when filtrate was concentrated into 50 ℃.
3, according to the described soft capsule preparation of claim 1, the granularity that it is characterized in that step 1 Chinese medicine fine powder is 80～120 orders, and the smashing fineness of step 4 Chinese medicine is 100～200 orders.
4,, it is characterized in that disperse medium can be PEG400 or vegetable oil in the step 4 according to the described soft capsule preparation of claim 1; Suspending agent can be 1%～5% PEG4000 or 6000, Cera Flava, aluminum monostearate or ethyl cellulose.
5,, it is characterized in that the blended ratio of step 4 Chinese medicine powder and disperse medium is 1～8: 1～8 according to the described soft capsule preparation of claim 1.
6, according to the described soft capsule preparation of claim 1, the step that it is characterized in that suppressing the soft capsule grain is molding 2～4 hours in the drum-type make-up machine, condition of molding is 25～30 ℃ of temperature, relative humidity 15～25%, wash ball, put to dry in the air in the dish that dries in the air and put dry 15～30 hours then with 90～99% ethanol then, 20～30 ℃ of drying conditions, humidity 15～25%.
7, according to the described soft capsule preparation of claim 1, its preparation method is preferably:
Get Radix Salviae Miltiorrhizae 40g, Radix Paeoniae Rubra 30g, Radix Polygoni Multiflori Preparata 30g, Fructus Lycii 30g, Radix Puerariae 30g, Rhizoma Chuanxiong 30g, Flos Carthami 20g, Rhizoma Alismatis 30g, Radix Achyranthis Bidentatae 30g, Pheretima 30g, Radix Curcumae 3g, Radix Polygalae (processed with honey) 30g, Rhizoma Anemones Altaicae 30g, Semen Ziziphi Spinosae (stir-fry) 20g, Cor Cervi powder 30g, Radix Glycyrrhizae 20g, more than ten Six-elements, except that the Cor Cervi powder, Rhizoma Chuanxiong, Flos Carthami, Rhizoma Alismatis, Radix Achyranthis Bidentatae, Radix Curcumae, Radix Polygalae, Rhizoma Anemones Altaicae, Semen Ziziphi Spinosae, Radix Glycyrrhizae powder are broken into 100 purpose fine powders, sieve.6 flavors such as all the other Radix Salviae Miltiorrhizaes add 4 times of water gagings with dynamic continuous countercurrent extraction method using and extracted 2 hours, filter, and relative density was 1.30 thick paste when filtrate was concentrated into 50 ℃.Add above-mentioned fine powder, mix drying, be crushed to 150 orders, sieve, add the Cor Cervi powder, mixing with the ratio adding fine drug powder of vegetable oil according to 2: 1, adds 3% Cera Flava mix homogeneously again, molding is 3 hours in the drum-type make-up machine, and condition of molding is 27 ℃ of temperature, relative humidity 20%, wash ball, put to dry in the air in the dish that dries in the air and put dry 24 hours then with 95% ethanol then, 26 ℃ of drying conditions, humidity 20% promptly gets soft capsule.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000304A (en) * | 2010-11-29 | 2011-04-06 | 杨凌无为制药集团有限公司 | Method for preparing Xinnaokang capsules |
| CN105664044A (en) * | 2016-03-03 | 2016-06-15 | 吉林省通化博祥药业股份有限公司 | Traditional Chinese medicine combined extract with anti-depression effect as well as preparation method and application thereof |
| CN105749148A (en) * | 2016-03-03 | 2016-07-13 | 吉林省通化博祥药业股份有限公司 | Traditional Chinese medicine combined extract with antifatigue effect as well as preparation method and application thereof |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1362158A (en) * | 2001-01-02 | 2002-08-07 | 杨孟君 | Nano Xinkaokang Medicine and its preparation |
| CN1224439C (en) * | 2002-03-09 | 2005-10-26 | 杭州春江自动化研究所 | Dynamic circulating-stage continuous countercurrent extraction process |
| CN1714859A (en) * | 2004-06-30 | 2006-01-04 | 天津天士力制药股份有限公司 | Use of composition containing red-rooted salvia root in preparing medicine for treating anti-aspirin |
| CN1994509B (en) * | 2006-01-05 | 2011-07-27 | 发泰（天津）科技有限公司 | Continuous countercurrent extraction method using dynamic overflow and apparatus thereof |
| CN101138686A (en) * | 2007-07-23 | 2008-03-12 | 沈军 | Method for extracting active ingredient of natural product and uses thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102000304A (en) * | 2010-11-29 | 2011-04-06 | 杨凌无为制药集团有限公司 | Method for preparing Xinnaokang capsules |
| CN102000304B (en) * | 2010-11-29 | 2013-04-10 | 杨凌无为制药集团有限公司 | Method for preparing Xinnaokang capsules |
| CN105664044A (en) * | 2016-03-03 | 2016-06-15 | 吉林省通化博祥药业股份有限公司 | Traditional Chinese medicine combined extract with anti-depression effect as well as preparation method and application thereof |
| CN105749148A (en) * | 2016-03-03 | 2016-07-13 | 吉林省通化博祥药业股份有限公司 | Traditional Chinese medicine combined extract with antifatigue effect as well as preparation method and application thereof |
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