CN102406785B - Guyuling tablet pharmaceutical composition and preparation method thereof - Google Patents

Guyuling tablet pharmaceutical composition and preparation method thereof Download PDF

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CN102406785B
CN102406785B CN 201010290297 CN201010290297A CN102406785B CN 102406785 B CN102406785 B CN 102406785B CN 201010290297 CN201010290297 CN 201010290297 CN 201010290297 A CN201010290297 A CN 201010290297A CN 102406785 B CN102406785 B CN 102406785B
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CN102406785A (en
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王巍
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JILIN LIHUA DRUG CO Ltd
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Abstract

The invention relates to a Guyuling tablet pharmaceutical composition and a preparation method thereof. Evening primrose oil which has a synergetic effect with the original Guyuling prescription is added based on the original Guyuling prescription, thus enhancing the medical effects of the pharmaceutical composition on alleviating pain, strengthening bone and treating osteoporosis. According to the invention, traditional Chinese medicinal materials are pulverized to form ultramicro powder by an ultramicrotechnique, so that the dissolution rates of active ingredients of crude drugs are increased, the pharmaceutical composition has a short disintegration time, full dissolution and high bioavailability, and the curative effect of the pharmaceutical composition is enhanced.

Description

Bone heal clever tablet medicine compositions and preparation method
Technical field
The present invention is the improvement to existing " bone is spirit more " pharmaceutical formulation, further is to disclose a kind of bone clever tablet medicine compositions that heals, and the preparation of drug combination method also is provided simultaneously, belongs to traditional Chinese medical science pharmaceutical technology field.
Background technology
The national standard for traditional Chinese medicines compilation orthopedics department fascicle of publishing in 2002 is recorded in " bone the is spirit more " pharmaceutical preparation that the present invention relates to, and function cures mainly and is " bone and muscle strengthening is used for osteoporosis for blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain ".Its prescription and technology are as follows: Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Rehmanniae Preparata 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, starch 20g, magnesium stearate 1g
1. above Radix Notoginseng, Sanguis Draxonis routine are ground into fine powder;
2. Olibanum, Myrrha are ground into fine powder, with above-mentioned two flavor facing-ups;
Pyritum, Borax respectively routine be ground into fine powder, behind the two facing-up again with above-mentioned mixed-powder facing-up;
4. ten flavor medical material routines such as all the other Flos Carthamis are ground into fine powder, mixing, and again with above-mentioned fine powder facing-up, mixing;
5. starch, magnesium stearate add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.
But, because " bone is spirit more " tablet is a starch, the tablet difficult forming, and the common industrial pulverizer pulverizing of former process using, granularity big (being generally 150 ~ 300 μ m), the effective ingredient dissolution of medicine is low, bioavailability is poor, thus the bad curative effect that influenced of drug absorption.
Summary of the invention
The invention discloses a kind of bone clever tablet medicine compositions that heals,, further improve blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, bone and muscle strengthening, the osteoporosis medical function of medicine the improvement of existing " bone is spirit more " pharmaceutical formulation.
The present invention also provides the preparation technology of this medicine, has solved to overcome the deficiencies in the prior art.
The bone of the present invention clever tablet medicine compositions that heals, by following medicine by weight mark than making:
Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 5 ~ 20g, poloxamer 188 1 ~ 8g, pregelatinized Starch 10 ~ 30g, Radix Oenotherae erythrosepalae oil 2 ~ 4g, magnesium stearate 1g.
Best prescription proportioning of the present invention is:
Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 10g, poloxamer 188 4g, pregelatinized Starch 20g, Radix Oenotherae erythrosepalae oil 3g, magnesium stearate 1g.
Preparation of drug combination method of the present invention may further comprise the steps:
Take by weighing each raw material by following weight:
1. above Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5 ~ 15 μ m fine powders;
2. Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1 preparation;
3. the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5 ~ 15 μ m fine powders, behind the two facing-up again with step 2 mixed-powder facing-up;
4. nine flavor medical material superfine powder such as all the other Flos Carthamis are broken into 5 ~ 15 μ m fine powders, mixing, and again with step 3 fine powder facing-up, mixing;
5. after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.
In prescription of the present invention, Rhizoma Drynariae, Radix Dipsaci, Cortex Acanthopancis bone and muscle strengthening, liver and kidney tonifying are monarch, Radix Notoginseng, Sanguis Draxonis, Flos Carthami, Radix Et Rhizoma Rhei restore menstrual flow and invigorate blood circulation, analgesic therapy is minister, Olibanum, Myrrha, Pyritum, Borax detumescence and promoting granulation, reunion of fractured tendons and bones are assistant, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Radix Paeoniae Rubra, the Radix Paeoniae Alba, Radix Oenotherae erythrosepalae oil are combined into mutually and make, all medicines share, treating both the principal and the secondary aspects of a disease at the same time.
The pharmaceutic adjuvant that the present invention uses, polyvinylpyrrolidone, poloxamer 188, pregelatinized Starch, except that having functions such as filler, binding agent, disintegrating agent, other has the medicine active ingredient dissolution of raising and sorbefacient function.
To hydrophobic drug, polyvinylpyrrolidone can make the even moistening of medicine, makes drug particles surface possess hydrophilic property, helps increasing the dissolution of medicine.
The hydrophilic of nonionic surfactant poloxamer itself can increase the wettability of medicine, and the high dispersion of medicine, can improve the dissolution in vitro of medicine.
Pregelatinized Starch can increase that some is water insoluble substantially and the water solublity of the material of pharmacologically active is arranged, and also has the medicine of promotion peptizaiton in addition.Pregelatinized Starch also has adsorption, is adsorbed on also to reduce interfacial surface tension on many interfaces to a certain extent, accelerates the absorption of medicine.
The present invention is with the good effect that " bone is spirit more " medicine is compared: add Radix Oenotherae erythrosepalae oil in " bone is spirit more " pharmaceutical formulation, with the collaborative compatibility of other each medicine, play the merit of blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, bone and muscle strengthening altogether, also increase the osteoporotic pharmacy effect of treatment simultaneously, and can urge the effect that fat-soluble medicine absorbs; Simultaneously an amount of Radix Oenotherae erythrosepalae oil also has the effect of lubricant, and tablet is had lubricated, fluidizer and anti-adhesion effect, helps the function that medicine is shaped and promotes drug absorption.Adopt ultramicrotechnique that the part Chinese crude drug is carried out superfine powder and be broken into 5 ~ 15 μ m fine powders, improved the dissolution of crude drug active ingredient, the molten diffusing time of medicine is short, and stripping is abundant, and the bioavailability height has strengthened the curative effect of medicine.
Clever sheet and the former technical recipe bone clever ginsenoside's absorbing state test of healing of healing of new process formula bone
Result of the test shows, adopts superfine grinding and " polyvinylpyrrolidone-poloxamer-pregelatinized Starch-Radix Oenotherae erythrosepalae oil " adjuvant system, can obviously increase ginsenoside Rb1 in the back rabbit blood sample of taking medicine, Rg1, Re concentration.
1 instrument and reagent
Instrument and reagent day island proper Tianjin LC-10AP chromatograph of liquid, the CLASS-VP chromatographic work station.
The bone clever sheet (former technology) of healing, the bone of the present invention clever sheet of healing, standard substance ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1, acetonitrile (chromatographically pure), methanol (analytical pure).
2 methods and result
2 hours ginsenoside Rg1 of 60 ℃ of drying under reduced pressure, ginsenoside Re and ginsenoside Rb1's reference substance are an amount of 2.1 the preparation of reference substance solution is learnt from else's experience, and adding methanol dilution, to be mixed with the ginsenoside Rg1 be 0.72mgml -1, Re is 0.63mgml -1And Rb1 is 0.47mgml -1Reference substance solution.The blank blood sample mixing of reference substance 1ml and rabbit 2ml, standby after the degerming.
2.2 chromatographic condition and system suitability test chromatographic column:
HypersiL-ODS (250mm * 4.6mm, 5 μ m); Mobile phase: acetonitrile-water (20: 80); Flow velocity: 0.8mLmin -1; Column temperature: 30 ℃; Detect wavelength: 203nm; Sample size: 20.0 μ l.
Reference substance solution and need testing solution are analyzed, and tested component separating degree meets the requirements.
System suitability the results are shown in Table 1:
Table 1 system suitability test result
Title Retention time/min Theoretical cam curve Adjacent two peak separating degrees
The ginsenoside Re 61.53 7025 1.7
The ginsenoside Rg1 34.27 7200 1.9
The ginsenoside Rb1 38.55 7545 1.6
2.3 20 rabbit fasting of method 24 hours.2 is the blank group, irritates stomach with normal saline; 3 is the original formulation group, irritates stomach with heal clever sheet of first wife's quadrate bone; 15 is the new technology group, irritates stomach with heal clever sheet of bone of the present invention.Two kinds of tablets face before irritating stomach and are made into 12mgml -1Suspension, with 1.5mgg -1Dosage irritate stomach, administration 3 times, each 6 hours at interval, the last time after the administration 7,8,9,10,11,12 hours blood drawing 5ml, blood sample was placed after 3 hours, centrifugal 20 minutes of 3500rpm.Add 3ml methanol mixing after drawing 2ml serum, 37 ℃ were extracted centrifugal 20 minutes of 3500rpm 1 hour in the constant temperature jolting extractor), to get supernatant and be settled in the 5ml volumetric flask, degerming is got 20.0 μ l sample introductions and is measured.
2.4 Rg1, Re absworption peak the ginsenoside Rb1 do not appear, in the blank group of result (1).(2) the clever sheet group administration of healing of former technology bone just occur to absorb after 10 hours.(3) absorbing appears after 7 hours in the bone of the present invention clever sheet group administration of healing.(4) former technology bone clever sheet group and the bone of the present invention clever sheet group administration ginsenoside Rb1 in the serum after 10 hours of healing of healing, Rg1, the relative percentage peak area of Re (comparing) with the reference substance absworption peak of every rabbit, the result shows the bone of the present invention ginsenoside Rb1 in the clever sheet group laboratory animal serum of healing, Rg1, Re concentration greatly improves, and is remarkable difference, the results are shown in Table 2.
Table 2 administration ginsenoside Rb1 in the serum after 10 hours, Rg1, the relative peak area of Re (100%)
Figure DEST_PATH_IMAGE001
The heal clinical efficacy comparative study of clever sheet of clever sheet and former method bone of healing of new combination formula technology bone:
Order ground is by clinical trial, contrast new process formula bone the heal clinical efficacy difference of clever sheet of clever sheet and former technical recipe bone that heals.
Method adopts the randomized, double-blind method that 27 routine fracture patient patients are divided into bone clever sheet I number group (embodiment 2 new combination formula technologies) 14 examples and the bone clever sheet II that heals that heals and number organizes (former technology preparation) 13 examples, carries out clinical observation.
1 clinical data
1.1 case is selected
Traumatic fracture 27 routine patients are divided into 2 groups at random.Bone No. 1, clever sheet group 14 examples that heal, male 7 examples, women 7 examples, the mean age 46.8 ± 11.3, Fracture of femur 5 examples wherein, chi is scratched bone 6 examples of fracturing, Patella fracture 2 examples, clavicular fracture 1 example.Bone clever sheet II number group 13 examples that heal, male 6 examples, women 7 examples, the mean age 47.7 ± 12.1, Fracture of femur 5 examples wherein, chi is scratched bone 5 examples of fracturing, Patella fracture 2 examples, clavicular fracture 1 example.Processing is learned at 2 groups of sexes, age, fracture and injury positions by statistics, there was no significant difference, and P>0.05 has comparability.
1.2 Therapeutic Method
2 groups of usage by specifications require usage and dosage identical, are 3 times on the 1st, and each 5,4 weeks were 1 course of treatment
1.3 observation item
Safety observation and adverse events are observed: general health check-up; Blood, urine, just routine examination; The heart, liver, kidney function test.Health giving quality observation: relevant sign inspection; Vertical percussion test and functional examination; The X ray examination.
1.4 curative effect determinate standard
General curative effect criterion clinical recovery: sign disappears, and X-ray film shows that fracture line is fuzzy, has the seriality callus formation;
Produce effects: sign is obviously improved, limb activity can, X-ray film shows that fracture line is fuzzy or a large amount of callus formation is arranged;
Effectively: sign is improved more obvious, but the limbs gentle activity, and X-ray film shows that fracture line is fuzzy or the moderate callus formation is arranged;
Invalid: sign is improved not obvious, and limb activity is poor, and X-ray film shows that fracture line exists, and does not see callus or rarely seen a small amount of formation.
2 results
In the treatment group, produce effects 13 examples, effective 1 example, total effective rate is 100%; In the matched group, produce effects 5 examples, effective 5 examples, invalid 3 examples, total effective rate is 76.9%; The X2 check divides as a result, and P<0.05, two a group comparing difference has statistical significance.In the therapeutic process, untoward reaction does not all take place in treatment group and matched group.
Contrast bone the heal clinical efficacy of clever sheet II number group of clever sheet I number group and bone of healing, the bone clever sheet I number group that heals is better than the bone clever sheet II number group that heals.
The specific embodiment
Embodiment 1.
Take by weighing each raw material by following weight: Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 5g, poloxamer 188 4g, pregelatinized Starch 10g, Radix Oenotherae erythrosepalae oil 1g, magnesium stearate 1g.
Preparation technology is as follows:
1. above Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5 ~ 15 μ m fine powders;
2. Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1 preparation;
3. the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5 ~ 15 μ m fine powders, behind the two facing-up again with step 2 mixed-powder facing-up;
4. nine flavor medical material superfine powder such as all the other Flos Carthamis are broken into 5 ~ 15 μ m fine powders, mixing, and again with step 3 fine powder facing-up, mixing;
5. after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.
Embodiment 2
Amount takes by weighing each raw material: Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 10g, poloxamer 188 4g, pregelatinized Starch 20g, Radix Oenotherae erythrosepalae oil 1g, magnesium stearate 1g.
1. above Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5 ~ 15 μ m fine powders;
2. Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1 preparation;
3. the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5 ~ 15 μ m fine powders, behind the two facing-up again with step 2 mixed-powder facing-up;
4. nine flavor medical material superfine powder such as all the other Flos Carthamis are broken into 5 ~ 15 μ m fine powders, mixing, and again with step 3 fine powder facing-up, mixing;
5. after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.
Embodiment 3
Take by weighing each raw material by following weight: Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 20g, poloxamer 188 8g, pregelatinized Starch 30g, Radix Oenotherae erythrosepalae oil 2g, magnesium stearate 1g.
1. above Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5 ~ 15 μ m fine powders;
2. Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1 preparation;
3. the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5 ~ 15 μ m fine powders, behind the two facing-up again with step 2 mixed-powder facing-up;
4. nine flavor medical material superfine powder such as all the other Flos Carthamis are broken into 5 ~ 15 μ m fine powders, mixing, and again with step 3 fine powder facing-up, mixing;
5. after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.
Embodiment 4
Take by weighing each raw material by following weight: Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 20g, poloxamer 188 8g, pregelatinized Starch 10g, Radix Oenotherae erythrosepalae oil 4g, magnesium stearate 1g.
1. above Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5 ~ 15 μ m fine powders;
2. Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1 preparation;
3. the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5 ~ 15 μ m fine powders, behind the two facing-up again with step 2 mixed-powder facing-up;
4. nine flavor medical material superfine powder such as all the other Flos Carthamis are broken into 5 ~ 15 μ m fine powders, mixing, and again with step 3 fine powder facing-up, mixing;
5. after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.
Embodiment 5
Take by weighing each raw material by following weight:
Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (system) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (forging) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 25g, poloxamer 188 3g, pregelatinized Starch 15g, Radix Oenotherae erythrosepalae oil 3g, magnesium stearate 1g.
1. above Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5 ~ 15 μ m fine powders;
2. Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1 preparation;
3. the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5 ~ 15 μ m fine powders, behind the two facing-up again with step 2 mixed-powder facing-up;
4. nine flavor medical material superfine powder such as all the other Flos Carthamis are broken into 5 ~ 15 μ m fine powders, mixing, and again with step 3 fine powder facing-up, mixing;
5. after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6. be pressed into 1000, the bag film-coat is made finished tablet, promptly.

Claims (3)

1. a bone clever tablet medicine compositions that heals, make by following medicine:
Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (processed) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (calcined) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 5 ~ 20g, poloxamer 188 1 ~ 8g, pregelatinized Starch 10 ~ 30g, Radix Oenotherae erythrosepalae oil 2 ~ 4g, magnesium stearate 1g.
2. pharmaceutical composition according to claim 1 is characterized in that being made by following medicine:
Radix Notoginseng 60g, Sanguis Draxonis 60g, Flos Carthami 30g, Olibanum (processed) 20g, Radix Et Rhizoma Rhei 20g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 20g, Myrrha (processed) 20g, Radix Paeoniae Alba 20g, Radix Paeoniae Rubra 20g, Rhizoma Drynariae 20g, Radix Dipsaci 20g, Pyritum (calcined) 20g, Cortex Acanthopancis 20g, Borax 20g, polyvinylpyrrolidone K30 10g, poloxamer 188 4g, pregelatinized Starch 20g, Radix Oenotherae erythrosepalae oil 3g, magnesium stearate 1g.
3. the preparation method of claim 1 or 2 described medicines may further comprise the steps:
1) Radix Notoginseng, Sanguis Draxonis superfine powder are broken into 5~15 μ m fine powders;
2) Olibanum, Myrrha are ground into fine powder, with two flavor facing-ups of step 1) preparation;
3, the Pyritum routine is ground into fine powder, and the Borax superfine powder is broken into 5~15 μ m fine powders, behind the two facing-up again with step 2) the mixed-powder facing-up;
4) all the other nine flavor medical material superfine powder are broken into 5~15 μ m fine powders, and mixing is again with step 3) fine powder facing-up, mixing;
5) after poloxamer 188, polyvinylpyrrolidone K30 use an amount of 60~95% ethanol dispersing and dissolvings respectively, add facing-up in the above-mentioned Chinese crude drug fine powder, mixing in the lump with pregelatinized Starch, Radix Oenotherae erythrosepalae oil, magnesium stearate;
6) be pressed into 1000, the bag film-coat is made finished tablet, promptly.
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