The specific embodiment
The specific embodiment one: the present embodiment 'Sheng Mai ' drop pills concentrates thick paste or dry powder and 1~8 part of substrate by 1 part of principal agent by ratio of weight and the number of copies and makes; Wherein concentrated thick paste of principal agent or dry powder are made by 1 part of Radix Ginseng Rubra, 2 parts of Radix Ophiopogonis and 1 part of Fructus Schisandrae Chinensis by ratio of weight and the number of copies.
The content of present embodiment substrate can satisfy the quick acting of 'Sheng Mai ' drop pills principal agent, can too much not increase dosage because of the content of substrate again.
The present embodiment principal agent concentrates thick paste or dry powder selects for use Radix Ginseng Rubra to make, and will be processed into respectively with a collection of bright ginseng to make 'Sheng Mai ' drop pills behind Radix Ginseng and the Radix Ginseng Rubra and compare test:
(1) contrast test of bringing out property of PIT rats with myocardial ischemia ST section deviation value:
This experiment divides 4 groups to be carried out, every group of 10 Winstar rats, and medicine adopts administration by gavage to take by be distilled water dissolution with equal proportion after.The 1st group of rat do not taken medicine; The 2nd group of rat taken the Radix Ginseng Rubra 'Sheng Mai ' drop pills; The 3rd group of rat taken SHENGSHAISHEN SHENGMAI DIWAN; The 4th group of rat taken FUFANG DANSHEN DIWAN; The 2nd~4 group of rat every day is by every kg body weight administration 4g; Took medicine 7 days, behind last administration 0.5h, the pentobarbital sodium of 4 groups of whole injections 3% of rat carries out light anaesthesia, faces upward the fixing normal two road ECG (electrocardiogram) of survey in position then, press rat body weight sublingual vein clump injection PIT 0.001mL/g afterwards, write down the two road ECG (electrocardiogram) of 5min again.It is as shown in table 1 that each organizes rat ST section deviation value.
Table 1
Group |
ST section deviation value (mv) |
1 |
0.06±0.01 |
2 |
0.02±0.01 |
3 |
0.03±0.02 |
4 |
0.03±0.01 |
Compare with the 1st group for the 2nd group: P<0.01; Compare with the 1st group for the 4th group: P<0.05.
(2) contrast test of rat blood serum LDH, CPK, SOD, MDA level:
This experiment divides 4 groups to be carried out, every group of 10 Winstar rats, and medicine adopts the administration by gavage administration by be distilled water dissolution with equal proportion after.The 1st group of rat gives the distilled water of equal volume; The 2nd group of rat taken the Radix Ginseng Rubra 'Sheng Mai ' drop pills; The 3rd group of rat taken SHENGSHAISHEN SHENGMAI DIWAN; The 4th group of rat taken FUFANG DANSHEN DIWAN; The 2nd~4 group of rat every day is by every kg body weight administration 4g; Took medicine 7 days, behind last administration 0.5h, the pentobarbital sodium of 4 groups of whole injections 3% of rat carries out light anaesthesia, presses rat body weight sublingual vein clump injection PIT 0.001mL/g then, and heart extracting blood behind the injection PIT3h detects LDH, CPK, SOD and MDA value.It is as shown in table 2 that each organizes rat LDH, CPK, SOD and MDA value.
Table 2
Group |
CPK(U/L) |
LDH(U/L) |
SOD(RU/L) |
MDA(μmol/mL) |
1 |
1021.8±326.5 |
1173.5±246.1 |
159.33±18.09 |
15.72±1.37 |
2 |
689.3±288.7 |
705.3±296.4 |
398.87±17.21 |
10.65±1.46 |
3 |
842.5±378.1 |
803.2±297.3 |
279.32±14.02 |
12.73±1.97 |
4 |
827.6±278.5 |
698.6±363.1 |
288.50±17.23 |
12.22±2.34 |
Compare with the 1st group for the 2nd group: P<0.01; Compare with the 3rd group for the 2nd group: P<0.05.
(3) contrast test of mice anoxia enduring:
This experiment divides 3 groups to carry out, and 15 every group, body weight are the mice of 20 ± 2g, and medicine adopts the administration by gavage administration by be distilled water dissolution with equal proportion after.The 1st group of mice gives the distilled water of equal volume; The 2nd group of mice taken the Radix Ginseng Rubra 'Sheng Mai ' drop pills; The 3rd group of mice taken SHENGSHAISHEN SHENGMAI DIWAN; The the 2nd and 3 group of mice every day is by every kg body weight administration 4g; Took medicine 8 days, behind last administration 1h, except that the 1st group,, behind the injection 15min 3 groups of mices are put into the 250mL port grinding bottle that fills sodica calx respectively all by every kilogram of lumbar injection 20mg of mice body weight, 0.1% isoproterenol, airtight port grinding bottle, the record mice time-to-live.It is as shown in table 3 that each organizes the mice time-to-live.
Table 3
Group |
Time-to-live (min) |
1 |
19.2±1.7 |
2 |
33.1±2.3 |
3 |
25.6±1.8 |
Compare with the 3rd group for the 2nd group: P<0.05.
3 parts of contrast test data show that under same dose Radix Ginseng Rubra side's 'Sheng Mai ' drop pills resists myocardial ischemia and the ability that improves anoxia enduring obviously is better than Radix Ginseng side's 'Sheng Mai ' drop pills.
Table 4 is present embodiment 'Sheng Mai ' drop pills treatment viral myocarditis, coronary heart disease, angina pectoris, arrhythmia, shortness of breath and palpitation, uncomfortable in chestly has a pain and the clinical experiment report of chronic heart failure.
Usage and dosage: every day three times, each 3g~4g, sublingual administration.
Patient to 30 17~76 years old age of example treats, effectively (state of an illness alleviation, doing well,improving) rate is higher than 99%, treatment viral myocarditis, coronary heart disease, angina pectoris, arrhythmia, shortness of breath and palpitation, uncomfortable in chest have a pain and the effect of chronic heart failure as shown in table 1, wherein the diagnosis that regular hospital provides is accepted and believed in state of an illness diagnosis.
Table 4
Number |
Age |
Sex |
Disease or symptom |
Therapeutic effect |
1 |
17 |
The man |
Viral myocarditis |
Effectively |
2 |
60 |
The woman |
Viral myocarditis |
Effectively |
3 |
46 |
The man |
Viral myocarditis |
Effectively |
4 |
35 |
The man |
Viral myocarditis |
Effectively |
5 |
56 |
The woman |
Viral myocarditis |
Effectively |
6 |
27 |
The man |
Viral myocarditis |
Effectively |
7 |
33 |
The man |
Viral myocarditis |
Effectively |
8 |
46 |
The woman |
Coronary heart disease |
Effectively |
9 |
39 |
The man |
Coronary heart disease |
Effectively |
10 |
62 |
The man |
Coronary heart disease |
Effectively |
11 |
76 |
The man |
Coronary heart disease |
Effectively |
12 |
64 |
The woman |
Angina pectoris |
Effectively |
13 |
72 |
The woman |
Angina pectoris |
Effectively |
14 |
43 |
The man |
Angina pectoris |
Effectively |
15 |
53 |
The woman |
Angina pectoris |
Effectively |
16 |
31 |
The woman |
Arrhythmia |
Effectively |
17 |
29 |
The man |
Arrhythmia |
Effectively |
18 |
49 |
The man |
Arrhythmia |
Effectively |
19 |
37 |
The woman |
Arrhythmia |
Effectively |
20 |
50 |
The man |
Arrhythmia |
Effectively |
21 |
68 |
The woman |
Shortness of breath and palpitation |
Effectively |
22 |
67 |
The man |
Shortness of breath and palpitation |
Effectively |
23 |
50 |
The man |
Shortness of breath and palpitation |
Effectively |
24 |
36 |
The woman |
Uncomfortable in chestly have a pain |
Effectively |
25 |
53 |
The woman |
Uncomfortable in chestly have a pain |
Effectively |
26 |
42 |
The man |
Uncomfortable in chestly have a pain |
Effectively |
27 |
67 |
The man |
Chronic heart failure |
Effectively |
28 |
76 |
The man |
Chronic heart failure |
Effectively |
29 |
69 |
The woman |
Chronic heart failure |
Effectively |
30 |
61 |
The man |
Chronic heart failure |
Effectively |
The specific embodiment two: the difference of the present embodiment and the specific embodiment one is: substrate is one or more compositions in Polyethylene Glycol, polyoxyethylene stearate 40 esters, stearic acid, sodium stearate, glycerin gelatine, poloxamer, the Lac.Other is identical with the specific embodiment one.
The specific embodiment three: the difference of the present embodiment and the specific embodiment one is: substrate is Polyethylene Glycol, polyoxyethylene stearate 40 esters, stearic acid, sodium stearate, glycerin gelatine, poloxamer or Lac.Other is identical with the specific embodiment one.
The substrate that present embodiment is used has the function of surfactant, ingredient in the principal agent can be scattered in the substrate with molecule, colloid or microcrystalline state, increased the surface area of ingredient, again because substrate is hydroaropic substance, medicine had wetting action, so more accelerated the speed of 'Sheng Mai ' drop pills dissolving, absorption, improved bioavailability.
The specific embodiment four: the difference of the present embodiment and the specific embodiment one is: substrate is Polyethylene Glycol.Other is identical with the specific embodiment one
The specific embodiment five: present embodiment and the specific embodiment two, three or fours' difference is: Polyethylene Glycol is a Polyethylene Glycol
2000, Polyethylene Glycol
4000, Polyethylene Glycol
6000, Polyethylene Glycol
8000, Polyethylene Glycol
10000Or Polyethylene Glycol
200000Other is identical with the specific embodiment two, three or four.
The specific embodiment six: the difference of the present embodiment and the specific embodiment one is: substrate is Polyethylene Glycol
6000Other is identical with the specific embodiment one.
The specific embodiment seven: the difference of the present embodiment and the specific embodiment one is: 'Sheng Mai ' drop pills concentrates thick paste or dry powder and 2~7 parts of substrate by 1 part of principal agent by ratio of weight and the number of copies and makes.Other is identical with the specific embodiment one.
The specific embodiment eight: the difference of the present embodiment and the specific embodiment one is: 'Sheng Mai ' drop pills concentrates thick paste or dry powder and 3~6 parts of substrate by 1 part of principal agent by ratio of weight and the number of copies and makes.Other is identical with the specific embodiment one.
The specific embodiment nine: the difference of the present embodiment and the specific embodiment one is: substrate is made up of Polyethylene Glycol, stearic acid and glycerin gelatine.Other is identical with the specific embodiment one.
The specific embodiment ten: present embodiment is described in conjunction with Fig. 1, the present embodiment 'Sheng Mai ' drop pills is prepared according to the following steps: (one) Radix Ginseng Rubra, Radix Ophiopogonis, Fructus Schisandrae Chinensis pulverize separately mix the alcohol dipping 24h of reuse Radix Ginseng Rubra, Radix Ophiopogonis and 5~8 times of Fructus Schisandrae Chinensis mixing coarse powder gross weights, volumetric concentration>50% by 1: 2: 1 weight ratio after becoming coarse powder; (2), collect the percolate of 1.3~3.4 times of dipping ethanol volumes with the speed percolation of 3~5mL/min; (3) percolate being condensed into density under the condition of temperature<80 ℃, pressure<0.1MPa is that the thick paste or the spray drying of 1.20~1.40 (surveying in 60~65 ℃ of environment) made dry powder; (4) will concentrate thick paste by 1: 1~8 weight ratio or dry powder mixes with substrate; (5) with the mixture heated to 90 in the previous step~100 ℃, putting into preheat temperature after stirring and be 70~100 ℃, water dropper internal diameter is the drop pill machine of 2.5mm; (6) drip system: dripping the system temperature is 70~95 ℃, dripping speed is 60~90 droplets/minute, the distance of condensing agent liquid level is 5~15cm in water dropper and the condensing tube, and the upper temp of condensing agent remains 20~40 ℃ in the condensing tube, and the temperature of lower of condensing agent remains 0~15 ℃ in the condensing tube; (7) treat drop pill in condensing agent the molding after-filtration, remove condensing agent, the drying on drop pill surface again, promptly obtain 'Sheng Mai ' drop pills.
Present embodiment drop pill 5 falls into the condensing tube that condensing agent 1 is housed, and it is 20~40 ℃ that upper coolant 2 can keep the first half temperature of condensing agent 1 in the condensing tube, and it is 0~15 ℃ that bottom liquid coolant 6 can keep the latter half temperature of condensing agent 1 in the condensing tube; Insulating layer 3 between upper coolant 2 and the bottom liquid coolant 6 and not heat conduction condensation tube wall 4 can reduce energy consumption effectively.Present embodiment is because of adopting the stagewise cooling, and air bubble content is few in the drop pill, and the drop pill dose is accurate, shapeliness.
The specific embodiment 11: the difference of the present embodiment and the specific embodiment ten is: the particle diameter of Radix Ginseng Rubra, Radix Ophiopogonis and Fructus Schisandrae Chinensis coarse powder is 0.2mm~2mm in the step ().Other step is identical with the specific embodiment ten.
The specific embodiment 12: present embodiment with the difference of the specific embodiment ten is: in the step () be 65%~80% alcohol dipping 24h with Radix Ginseng Rubra, Radix Ophiopogonis and 6 times of Fructus Schisandrae Chinensis mixing coarse powder gross weights, volumetric concentration.Other step is identical with the specific embodiment ten.
The specific embodiment 13: the difference of the present embodiment and the specific embodiment ten is: with the speed percolation of 4mL/min, collect the percolate of 1.5~3.2 times of dipping ethanol volumes in the step (two).Other step is identical with the specific embodiment ten.
The specific embodiment 14: the difference of the present embodiment and the specific embodiment ten is: step (three) is condensed into percolate density under the condition of temperature<70 ℃, pressure<0.01MPa be that 1.25~1.35 thick paste or spray drying are made dry powder.Other step is identical with the specific embodiment ten.
The specific embodiment 15: present embodiment with the difference of the specific embodiment ten is: step (four) will concentrate thick paste by 1: 2~7 weight ratio or dry powder mixes with substrate.Other step is identical with the specific embodiment ten.
The specific embodiment 16: the difference of the present embodiment and the specific embodiment ten is: it is 75~90 ℃ that step (six) is dripped the system temperature, dripping speed is 65~85 droplets/minute, the distance of condensing agent liquid level is 7~13cm in water dropper and the condensing tube, the upper temp of condensing agent remains 25~35 ℃ in the condensing tube, and the temperature of lower of condensing agent remains 5~10 ℃ in the condensing tube.Other step is identical with the specific embodiment ten.
The specific embodiment 17: the difference of the present embodiment and the specific embodiment ten is: the upper temp of condensing agent remains 20~25 ℃ in the middle condensing tube of step (six), and the temperature of lower of condensing agent remains 0~10 ℃ in the condensing tube.Other step is identical with the specific embodiment ten.
The specific embodiment 18: the difference of present embodiment and the specific embodiment ten or 16 is: the condensing agent in the step (six) is one or more compositions in methyl-silicone oil, liquid paraffin, the vegetable oil.Other step is identical with the specific embodiment ten or 16.