CN100333785C - Preparation for eliminating thrombus and promoting lactation, and its preparation method - Google Patents
Preparation for eliminating thrombus and promoting lactation, and its preparation method Download PDFInfo
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Abstract
The present invention relates to medicine for eliminating thrombus and promoting channels and a preparation method thereof. The medicine is characterized in that hemlock parsley, milkvetch root, red sage root, notoginseng, cassia twig, water plantain, sophora flower, curcuma root, common aucklandia root, hawthorn fruit and borneol are used as raw material, and the methods of aqueous extraction and alcohol deposition, ethanol extraction, supercritical extraction, macroporous resin adsorption, etc. are respectively used to prepare any preparation of pharmaceutics. The effective components of medicinal material can be sufficiently extracted by using the method of the present invention so that the dose of the medicine can be reduced, and the medicine can be conveniently used by patients. On the other hand, solid powder prepared by the method of the present invention has high stability. Thus, the problem of particularly easy water absorption of the traditionally prepared medicine powder of capsules for eliminating thrombus and promoting channels can be solved.
Description
Technical field
The present invention relates to the medicine of the eliminating thrombus and removing obstruction in channels of a kind of blood circulation promoting and blood stasis dispelling, promoting the flow of QI in the collateral by warming the meridian, more particularly, it be a kind of be meidcine ' Xiaoshuan Tongluo ' of making of raw material and preparation method thereof with Chinese herbal medicine such as Rhizoma Chuanxiong, the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, Ramulus Cinnamomi, Rhizoma Alismatis.
Background technology
The eliminating thrombus and removing obstruction in channels preparation mainly contains effects such as blood circulation promoting living silt, promoting the flow of QI in the collateral by warming the meridian, is applicable to that blood fat increases, the dull mind that cerebral thrombosis causes, and tongue is former to harden, and speech is puckery late, asophia, hands and feet coolness, activity pain.Traditional XIAOSHUAN TONGLUO JIAONANG major part medical material adopts water extraction to extract medical material, and another part medical material then is directly to be used as medicine after pulverizing, so the medicated powder moisture absorption very easily, and dose is big, is unfavorable for that the patient uses.
Summary of the invention
The objective of the invention is to overcome the shortcoming of known eliminating thrombus and removing obstruction in channels medicine, the eliminating thrombus and removing obstruction in channels that a kind of patient of convenience uses and dose is little medicine is provided.
Raw material and weight proportion thereof that medicine of the present invention is used are as follows:
Rhizoma Chuanxiong 9-18, Radix Astragali 10-25, Radix Salviae Miltiorrhizae 6-15, Radix Notoginseng 4-10, Ramulus Cinnamomi 4-10, Rhizoma Alismatis 4-9, Flos Sophorae 2-4, Radix Curcumae 4-9, Radix Aucklandiae 2-4, Fructus Crataegi 4-9, Borneolum Syntheticum 0.2-0.5.
This has the used raw material preferred weight proportioning of medicine:
Rhizoma Chuanxiong 10-14, Radix Astragali 15-21, Radix Salviae Miltiorrhizae 8-10, Radix Notoginseng 5-7.5, Ramulus Cinnamomi 5-7, Rhizoma Alismatis 5-7, Flos Sophorae 2-4, Radix Curcumae 5-7, Radix Aucklandiae 2-4, Fructus Crataegi 5-7, Borneolum Syntheticum 0.2-0.3.
The raw material optimum weight proportioning that thing of the present invention is used:
Rhizoma Chuanxiong 12, the Radix Astragali 18, Radix Salviae Miltiorrhizae 9, Radix Notoginseng 6, Ramulus Cinnamomi 6, Rhizoma Alismatis 6, Flos Sophorae 3, Radix Curcumae 6, the Radix Aucklandiae 3, Fructus Crataegi 6, Borneolum Syntheticum 0.25.
Preparation of pharmaceutical formulations method of the present invention may further comprise the steps:
(1) Radix Astragali, extracting in water 1-5 time, each amount of water is 4-20 times of institute's extractions Radix Astragali dose, extraction time is 0.5-10 hour, filtration, merging filtrate is concentrated, is dried to driedly, and it is standby to be ground into fine powder;
(2) Rhizoma Chuanxiong, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae add water and carry 1-5 time, each amount of water be the Rhizoma Chuanxiong, Ramulus Cinnamomi and the Radix Salviae Miltiorrhizae crude drug amount 4-25 that are extracted doubly, each extraction time is 0.5-5 hour, filter, merging filtrate also is concentrated into the fluid extract of relative density 1.05-1.25, adds the 1-30 10-99.5% ethanol doubly of the fluid extract total amount of extracting while hot, abundant stirring, left standstill 5-96 hour, get supernatant, reclaim ethanol, be dried to dried, be ground into fine powder, standby;
(3) Rhizoma Alismatis adds 10-99.5% ethanol extraction 1-5 time, each alcohol adding amount be the Rhizoma Alismatis crude drug amount extracted 3-25 doubly, each extraction time is 0.5-5 hour, filters, merging filtrate reclaims ethanol and also is concentrated into fluid extract (water content is below 12%), and is standby;
(4) Fructus Crataegi, Flos Sophorae add 10-99.5% ethanol extraction 1-5 time, each alcohol adding amount be the Fructus Crataegi of being extracted, Flos Sophorae crude drug amount 3-25 doubly, each extraction time is 0.5-5 hour, filter, merging filtrate reclaims ethanol and is concentrated into relative density 1.01-1.25 liquid or extractum, adds mineral acid 10-10000ml while hot, 40-100 ℃ is incubated 10-600 minute, leave standstill, abandoning supernatant, precipitation adds and is washed to PH2-7, be dried to driedly, it is standby to be ground into fine powder;
(5) Radix Notoginseng is pulverized, add the 10-99.5% ethanol extraction respectively 1-5 time, each alcohol adding amount be the Radix Notoginseng crude drug amount extracted 3-25 doubly, each extraction time is 0.5-5 hour, filter, merging filtrate reclaims ethanol to relative density 1.01-1.30 liquid, adopt absorption with macroporous adsorbent resin, with resin with extract medical material total amount 0.5-20: the ratio upper prop of 1-10,2-30 times of water gaging eluting with pseudo-ginseng weight discards water elution liquid, renew 2-30 10-99 doubly with pseudo-ginseng weight, 5% ethanol elution, collect ethanol elution, reclaim ethanol, be dried to dried, be ground into fine powder, standby;
(6) Radix Curcumae, Radix Aucklandiae powder are broken into coarse powder, extracted volatile oil in steam distillation 1-15 hour, or employing supercritical extraction, extract pressure 2-30MPa, temperature 0-100 ℃, extraction ratio 1-8%, get above extract respectively, doubly measure cyclodextrin with the 2-30 of extract and carry out enclose, lyophilization or 35-50 ℃ is dried to dried, standby;
(7) with gained dry powder and fluid extract among the step 1-6 and Borneolum Syntheticum mix homogeneously, add any or multiple blended medicinal diluent, base unit weight is dry powder and fluid extract weight 0.1-1.5 a times, mix thoroughly, be ground into fine powder or make the granule of 0.2-3mm, make various pharmaceutical preparatioies after making pharmaceutical preparation or coating then.
The described Radix Astragali, Rhizoma Alismatis, Radix Curcumae also can adopt the water extract-alcohol precipitation method of step (2) to extract.
Described Radix Notoginseng, Radix Curcumae, Radix Salviae Miltiorrhizae, the Radix Aucklandiae, Chinese scholartree stilbene, Fructus Crataegi also can adopt the ethanol extraction method of step (3) to extract.
Described Radix Salviae Miltiorrhizae also can adopt the macroporous resin adsorption method of step (5) to extract.
Described Rhizoma Chuanxiong, Ramulus Cinnamomi also can adopt the steam distillation method of step (6) or supercritical extraction method to extract.
The described mineral acid of step (4) comprises any acid of hydrochloric acid, sulphuric acid, nitric acid.
The described macroporous adsorbent resin of step (5) is selected from any macroporous resin that comprises AB-8 type, D101 type, HP-20 type, described AB-8 type resin and D101 type resin are Cangzhou precious grace chemical industry company limited production, and described HP-20 type resin is produced for Mitsubishi chemical company.
The described inclusion method of step (6) comprises saturated water solution method, supercritical ultrasonics technology, polishing, freeze-drying or spray drying method.
The described medicinal diluent of step (7) comprise starch, dextrin, Icing Sugar, mannitol and comprise the oxide of aluminum, magnesium, calcium or the antiacid material of hydroxide in one or more blended medicinal diluents.
The described pharmaceutical preparation of step (7) can be made into said any dosage form on the pharmaceutics, comprises tablet, capsule, granule, pill, powder, membrane, microcapsule, drop pill, aerosol, unguentum syrup, oral agents, mixture.
Medicine taking dose every day 2.0-2.3g of the present invention.
Advantage of the present invention and effect:
Medicine of the present invention can be used for treating blood fat and increases, and dull mind, the body of the tongue that cerebral thrombosis causes hardened, diseases such as speech is puckery late, asophia, hands and feet coolness, activity pain; The present invention is owing to adopt different extracting method to comprise water extract-alcohol precipitation, ethanol extraction to various Chinese herbal medicine, method such as supercritical extraction, macroporous resin adsorption, fully extract the active ingredient in the medicine, remove the non-medicinal impurity of part simultaneously, therefore the pharmaceutical preparation of making is under equal drug effect situation, its dose (2.0-2.3g/ day) be traditional XIAOSHUAN TONGLUO JIAONANG preparation dose (6.7g/ day) 1/3, in addition, the pressed powder good stability that method of the present invention is made, its critical relative humidity raises 5%.
The specific embodiment
Example 1
This example is that preparation eliminating thrombus and removing obstruction in channels tablet medicine concrete steps of the present invention are as follows:
(1) in the 180g Radix Astragali, adds and extract 3 times, add water 1800g at every turn, extracted 2 hours, filter, merges three times filtrate, concentrated, drying, be ground into fine powder.
(2) get 120g Rhizoma Chuanxiong, 60g Ramulus Cinnamomi, the mixing of 90g Radix Salviae Miltiorrhizae, extracting in water three times adds 2700g water at every turn, extracted 2 hours, filter, merge three times filtrate, being concentrated into relative density then is 1.25 fluid extracts, 10 times 99.5% ethanol that adds the fluid extract total amount while hot, fully stir, left standstill 24 hours, get supernatant, reclaim ethanol, dry, be ground into fine powder.
(3) get the 60g Rhizoma Alismatis, add 60% ethanol extraction three times, add 60% ethanol 600g at every turn, extracted 1 hour at every turn, filter, merge three times filtrate, reclaim ethanol, be concentrated into fluid extract (water content is below 12%);
(4) get 60g Fructus Crataegi and 30g Flos Sophorae and mix, 99.5% ethanol extraction three times adds 99.5% amount of alcohol 1800g at every turn, the each extraction 2 hours filters merging filtrate, reclaim ethanol, being concentrated into relative density is 1.20 liquid, adds 1000ml hydrochloric acid while hot, be incubated 1.5 hours, left standstill 48 hours, abandoning supernatant, it is 3 that the precipitation adding is washed to pH value, dry then, be ground into fine powder;
(5) get the 60g Radix Notoginseng and add 99.5% ethanol extraction 3 times, each alcohol adding amount is 600g, and extraction time is 1 hour, filter, merging filtrate reclaims ethanol, be concentrated into relative density to 1.05 liquid, it is encased on the filling D101 type macroporous resin absorption post, and its resin is 10: 3 with the ratio of medical material total amount, uses the water elution of 10 times of amounts of medical material weight, discard water lotion, 10 times 99.5% ethanol elution of reuse medical material weight is collected ethanol and reclaimed, and is dry then, be ground into fine powder;
(6) the 60g Radix Curcumae and the 30g Radix Aucklandiae are pulverized, mix, use steam distillation 5 hours, extract volatile oil, use the 900g cyclodextrin then, under 40 ± 5 ℃, be dried to dried to using the polishing enclose;
(7) with step (1) to step (6) gained dry powder and fluid extract and 2.5g Borneolum Syntheticum mix homogeneously, add starch 2.5g, mix thoroughly, be ground into fine powder, make tablet then.
Example 2
This example is a preparation XIAOSHUAN TONGLUO JIAONANG agent medicine of the present invention.
The raw material consumption of medicine of the present invention: Rhizoma Chuanxiong 200g, Radix Astragali 360g, Radix Salviae Miltiorrhizae 280 g, Radix Notoginseng 160g, Ramulus Cinnamomi 160g, Rhizoma Alismatis 140g, Flos Sophorae 40g, Radix Curcumae 80g, Radix Aucklandiae 60g, Fructus Crataegi 100g, Borneolum Syntheticum 6g.
Preparation method is just made capsule at last with example 1.
Example 3
This example is the animal experiment of the medicine that makes by the inventive method.
Test material
Be subjected to reagent thing eliminating thrombus and removing obstruction in channels of the present invention to make with extra care capsule (XSTLJZ), clinical consumption is 3/time, every day 3 times.Specification: 0.45g/ grain, 3.59g crude drug/grain.Be that clinical consumption is 32.3g crude drug/day.Positive control drug XIAOSHUAN TONGLUO JIAONANG (XSTL), be that water extraction extracts, can buy on the market, be that Northeast Asia, Jilin Pharmaceutical limited company provides authentication code: the accurate word Z10940067 of traditional Chinese medicines number, lot number: 20030505, clinical consumption is 6/time, every day 3 times, specification: the 0.37g/ grain, it is standby to be subjected to the reagent thing all to be made into the desired concn suspension with distilled water.
Animal subject Kunming kind white mice, the Wistar rat, the qualified laboratory animal of one-level is bought by the Shenyang Medical College Experimental Animal Center, the quality certification number: SCXK (the Liao Dynasty) 2003-0016; Japan large ear rabbit, people's animal feeding factory before flood buys the quality certification number by Shenyang: SCXK (the Liao Dynasty) 2003-0011.Pellet is provided by people's animal feed factory before Shenyang City's Yuhong District.The quality certification number: No. 001, (the Liao Dynasty) searching.
22-25 ℃ of experimental situation laboratory temperature, humidity 45-60%.
The reagent sodica calx, calcium hydroxide factory of Beipiao City's mineral office, lot number: 000609; Cholesterol, Beijing extensive and profound in meaning star biotechnology responsibility company limited, lot number: 20031016; Sodium cholate, China Medicine (Group) Shanghai Chemical Reagent Co.,, import packing, lot number: F20030428; Propylthiouracil, Shanghai Fosun Zhaohui Pharmaceutical Co., Ltd., lot number: 020220; Tween 80, the Dalian elegant molecular sieve agent company limited of planting, lot number: 021218; Propylene glycol, the sincere bright chemical reagent work in Shenyang City, lot number: 20030313; The triglyceride test kit, the safe clinical reagent company limited of Beijing northization, lot number: 030516; The cholesterol reagent box, the safe clinical reagent company limited of Beijing northization, lot number: 031008; The low density lipoprotein, LDL test kit, Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd., lot number: 030218; ADP (5 '-adenosine diphosphate disodium salt), Shanghai uncle bio tech ltd difficult to understand, lot number: 20010302; Thrombin, Changchun Haiwang Bio-pharmaceuticals Pharmaceutical Co, lot number: 20030601; The adrenalin hydrochloride injection, Tianjin gold credit aminoacid company limited, lot number: 0311041; The ivens orchid, Fluka company, import packing; Sodium sulfate, Shenyang chemical reagent factory, lot number: 20021010; Acetone, Shenyang chemical reagent factory, lot number: 20020214; Prothrombin time test kit (PT), registration certificate number: No. the 3040111st, state's pencil tool (examination) word 2002; Thrombin time test test kit (TT), registration certificate number: No. the 3040117th, state's pencil tool (examination) word 2002; APTT test kit (APTT), registration certificate number: No. the 3040114th, state's pencil tool (examination) word 2002; Fibrinogen content is measured test kit (FIB), registration certificate number: state's pencil tool (examination) word 2002 the 3040116th; Pentobarbital sodium, SERVA import packing, the chemical plant is known in last sea-run, lot number: 921019; Sodium hydrogen phosphate: Shenyang City's reagent one factory's lot number: 820601; Sodium dihydrogen phosphate: Shenyang City's reagent one factory's lot number: 830516.
Instrument: ISP II type semi-automatic biochemical analyzer, Dutch Rittal GmbH; The full-automatic blood flow of the FASCO-3010A survey instrument that accelerates, Weiduo Bioengineering Institute of Chongqing University; LG-PABER platelet aggregation thrombin factorial analysis instrument, Beijing generation Supreme Being company;
Test method and result
1, the refining capsular mice normal pressure hypoxia endurance test of eliminating thrombus and removing obstruction in channels (the Qi Chen chief editor. herbal pharmacology research methodology Beijing: People's Health Publisher 1993.333)
Get body weight 18～22g healthy mice, male and female half and half are divided five groups at random by body weight, blank group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 1 dosage gastric infusion, the blank group is given the equivalent distilled water, administration volume 0.8ml/20g body weight, successive administration 3 days was put into the airtight wide mouthed bottle of the 250ml that the 10g sodica calx is housed in advance respectively with mice in 30 minutes after the last administration, was placed with circular filter paper on the sodica calx, bottleneck is coated with vaseline, seal after putting into mice, from putting into the time to respiratory arrest, t checks the significance of each group difference with stopwatch record mice.The results are shown in Table 1.
Table 1 eliminating thrombus and removing obstruction in channels is made with extra care capsule mice normal pressure hypoxia endurance test
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Time-to-live (branch) |
| The blank group | 10 | 44.7±3.80 | |
| The low group of XSTLJZ | 10 | 4.20 | 46.0±3.83 |
| Organize among the XSTLJZ | 10 | 8.40 | 49.1±8.01 * |
| The high group of XSTLJZ | 10 | 16.80 | 54.6±15.53 ** |
| The XSTL group | 10 | 1.73 # | 58.2±8.88 ** |
With blank group ratio
*P＜0.05
*P＜0.01
Dosage unit is g/kg
By table 1 as seen, the refining middle and high dosage group of capsule of eliminating thrombus and removing obstruction in channels can increase the time-to-live of mice normal pressure anoxia enduring, compares with the blank group, and its difference has statistical significance.Show that the refining capsule of eliminating thrombus and removing obstruction in channels can improve mouse brain and organize hypoxia-bearing capability, prolong the mice time-to-live.
The 2. refining capsular mice broken end ischemia of eliminating thrombus and removing obstruction in channels test (ten thousand Jinzhou etc. Chinese Pharmacological circular 1994.10 (1))
Get body weight 18～228 healthy mices, male and female half and half are divided five groups at random by body weight, blank group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 2 dosage gastric infusion, the blank group is given the equivalent distilled water, administration volume 0.8ml/20g body weight, successive administration 3 days, after the last administration 30 minutes, mice is 2mm place broken end rapidly behind ear, causes acute cerebral ischemia, with frequency of respiration and breathing persistent period before the death of stopwatch record mouse brain, t checks the significance of each group difference.The results are shown in Table 2.
The test of the refining capsular mice broken end ischemia of table 2 eliminating thrombus and removing obstruction in channels
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Frequency of respiration (inferior) | Persistent period (second) |
| The blank group | 10 | - | 4.80±2.30 | 9.88±1.77 |
| The low group of XSTLJZ | 10 | 4.20 | 8.10±3.73 * | 15.19±4.71 ** |
| Organize among the XSTLJZ | 10 | 8.40 | 9.20±3.65 * | 16.42±5.67 ** |
| The high group of XSTLJZ | 10 | 16.80 | 10.00±3.59 ** | 19.87±4.91 *** |
| The XSTL group | 10 | 1.73 # | 9.10±2.81 * | 18.09±3.86 *** |
With blank group ratio
*P＜0.05
*P＜0.01
* *P＜0.001
Dosage unit is g/kg
By table 2 as seen, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels can increase the frequency of respiration of the preceding mice of brain death, prolongs the mouse breathing persistent period, compares with the blank group, and its difference has statistical significance.Show that the refining capsule of eliminating thrombus and removing obstruction in channels has the effect that improves the chmice acute cerebral ischemia.
3, the refining capsular compound thrombosis derivant of eliminating thrombus and removing obstruction in channels cause the multiple cerebral thrombosis test of rat (Du Qun etc. Traditional Chinese Medicine University Of Guangzhou's journal 1999.16 (1) 38)
Get body weight 250～350g healthy rat, male and female half and half are divided into six groups at random by body weight, blank group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 3 dosage gastric infusion, the blank group is given the equivalent distilled water, administration volume 1ml/100g body weight, successive administration 5 days, after the last administration 30 minutes, the anesthesia of rats by intraperitoneal injection 45mg/kg pentobarbital sodium, operation separates right common carotid artery, (1.25mmol/LADP: 12.5 μ/ml thrombin: 0.1ml/100g 1mg/ml epinephrine=100: 200: 5), the blank group is injected normal saline to inject the thrombosis derivant through scalp acupuncture.After 5 minutes, inject the blue 0.5ml/100g of 0.5% ivens, after 5 minutes, broken end was got two cerebral hemispheres and is weighed rapidly, is cut into fragment, places homogenizer, added 0.5%Na
2SO
43ml and acetone 7ml, make homogenate, sealing, place more than 60 minutes, centrifugal 10 minutes of 3000r/min gets supernatant, return to zero with normal saline, in 620nm place colorimetric, represent the order of severity of content and the cerebral thrombosis of ivens orchid with the heavy ratio of trap and brain, t checks the significance of each group difference.The results are shown in Table 3.
The refining compound thrombosis derivant of capsule of table 3 eliminating thrombus and removing obstruction in channels causes the multiple cerebral thrombosis test of rat
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | The OD/ brain is heavy |
| The blank group | 10 | - | 0.021±0.010 |
| Model control group | 10 | - | 0.044±0.016 △△△ |
| The low group of XSTLJZ | 10 | 2.91 | 0.037 ±0.013 |
| Organize among the XSTLJZ | 10 | 5.82 | 0.028±0.009 * |
| The high group of XSTLJZ | 10 | 11.64 | 0.022±0.009 ** |
| The XSTL group | 10 | 1.20 # | 0.027±0.009 ** |
With blank group ratio
△ △ △P＜0.001 and model control group ratio
*P＜0.01
*P＜0.01
Dosage unit is g/kg.
By table 3 as seen, the content of model control group rat brain ivens orchid increases, and with blank group ratio, its difference has statistical significance, represents that compound thrombosis derivant causes the multiple cerebral thrombosis model of rat moulding success.The content of the refining middle and high dosage group of the capsule rat brain ivens orchid of eliminating thrombus and removing obstruction in channels reduces, and with the model control group ratio, its difference has statistical significance, shows that the refining capsule of eliminating thrombus and removing obstruction in channels has the effect that stops compound thrombosis derivant to cause the multiple cerebral thrombosis of rat.
4, the refining capsule of eliminating thrombus and removing obstruction in channels to high blood lipid model rat serum cholesterol, triglyceride, high density lipoprotein, the hemorheological influence of low-density lipoprotein Pseudobulbus Bletillae (Rhizoma Bletillae) (the Li Yikui chief editor. herbal pharmacology experimental methodology Beijing: People's Health Publisher 1993.P 320).
Get body weight 150～180g healthy rat, all male, be divided into six groups at random by body weight, blank group, model control group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Blank group hello normal diet every day, all the other are respectively organized every morning filling hello high lipoprotein emulsion (10ml/kg) and make high blood lipid model, every afternoon is except that blank group and model control group, all the other each groups are pressed table 4 dosage gastric infusion, the blank group is given the equivalent distilled water, administration volume 1ml/100g body weight, behind the successive administration 15 days, each organizes the equal fasting of rat 12 hours, after all animals anesthesia at once carotid artery get blood, press the method for test kit description, ISP II type semi-automatic biochemical analyzer is measured serum cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, LDL; The full-automatic blood flow of FASCO-3010A accelerates and surveys instrument mensuration hemorheological indexes, and t checks the significance of each group difference.The results are shown in Table 4, table 5.
The refining capsule of table 4 eliminating thrombus and removing obstruction in channels is to the influence of high blood lipid model rat serum cholesterol, triglyceride, high density lipoprotein, low density lipoprotein, LDL
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Cholesterol (mmol/L) | Triglyceride (mmol/L) | High density lipoprotein (mmol/L) | Low density lipoprotein, LDL (mmol/L) |
| The blank group | 10 | - | 1.32±0.38 | 0.60±0.18 | 1.22±0.31 | 1.22±0.45 |
| Model control group | 10 | - | 5.58±2.31 △△ △ | 1.12±0.41 △△ △ | 0.73±0.20 △△ △ | 4.30±2.29 △△△ |
| The low group of XSTLJZ | 10 | 2.91 | 3.44±1.56 * | 0.69±0.23 ** | 0.86±0.29 | 3.39±1.75 |
| Organize among the XSTLJZ | 10 | 5.82 | 3.28±2.32 * | 0.64±0.28 ** | 1.03±0.30 * | 2.06±1.14 * |
| The high group of XSTLJZ | 10 | 11.64 | 3.00±1.18 ** | 0.62±0.19 ** | 1.15±0.21 *** | 1.68±1.51 ** |
| The XSTL group | 10 | 1.20 # | 3.48±1.91 * | 0.71 ±0.33 * | 1.11±0.25 ** | 2.22±1.73 * |
With blank group ratio
△ △ △P＜0.001 and model control group ratio
*P＜0.01
*P＜0.01
* *P＜0.001
Dosage unit is g/kg
By table 4 as seen, model control group rat blood serum cholesterol, triglyceride, low density lipoprotein, LDL raise, and high density lipoprotein reduces, and with blank group ratio, its difference has statistical significance, expression high blood lipid model rat moulding success.Eliminating thrombus and removing obstruction in channels is made with extra care the basic, normal, high dosage group of capsule rat blood serum cholesterol, triglyceride reduces, the refining middle and high dosage group of the capsule rat blood serum low density lipoprotein, LDL of eliminating thrombus and removing obstruction in channels reduces, high density lipoprotein raises, with the model control group ratio, its difference has statistical significance, shows that the refining capsule of eliminating thrombus and removing obstruction in channels has the effect of tangible reduction high blood lipid model rat fat.
The refining capsule of table 5 eliminating thrombus and removing obstruction in channels is to the influence of high blood lipid model hemorheology of rat
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Whole blood viscosity (mPa.s) | ||
| Height is cut (200/s) | In cut (30/s) | Low cut (3/s) | |||
| The blank group | 10 | - | 4.192±0.696 | 5.158±0.895 | 9.849±0.937 |
| Model control group | 10 | - | 5.403±0.941 △△△ | 6.772±1.027 △△ △ | 11.739±0.909 △△△ |
| The low group of XSTLJZ | 10 | 2.91 | 5.078±0.976 | 6.430±1.147 | 11.500±0.763 |
| Organize among the XSTLJZ | 10 | 5.82 | 4.494 ±0.879 * | 5.661 ±0.640 ** | 10.891±0.874 * |
| The high group of XSTLJZ | 10 | 11.64 | 4.357±0.627 ** | 5.534±0.809 ** | 10.736±0.959 * |
| The XSTL group | 10 | 1.20 # | 4.456±0.643 * | 5.573±0.951 * | 10.801±0.989 * |
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Plasma viscosity (mPa.S) | Erythrocyte electrophoretic time (S) | Fibrinogen (G/L) |
| The blank group | 10 | - | 1.407±0.106 | 15.72±2.61 | 2.403±0.705 |
| Model control group | 10 | - | 1.611±0.091 △△△ | 20.62±3.53 △△ | 4.931±0.907 △△△ |
| The low group of XSTLJZ | 10 | 2.91 | 1.513±0.082 * | 17.92±2.98 | 4.577±0.938 |
| Organize among the XSTLJZ | 10 | 5.82 | 1.500 ±0.087 ** | 16.85 ±3.30 * | 3.913±0.866 * |
| The high group of XSTLJZ | 10 | 11.64 | 1.467±0.094 *** | 16.34±2.35 ** | 3.647±0.827 ** |
| The XSTL group | 10 | 1.20 # | 1.493±0.103 ** | 16.71±2.41 ** | 3.659±0.900 ** |
With blank group ratio
△ △P＜0.01
△ △ △P＜0.001
With the model control group ratio
*P＜0.01
*P＜0.01
* *P＜0.001
Dosage unit is g/kg
By table 5 as seen, the whole blood viscosity of model control group rat, plasma viscosity, erythrocyte electrophoretic time, Fibrinogen all have rising, and with blank group ratio, its difference has statistical significance, and it is reliable that expression this law is made rat high blood lipid model method.With the model control group ratio, eliminating thrombus and removing obstruction in channels is made with extra care Capsules group rat whole blood viscosity, plasma viscosity, erythrocyte electrophoretic time, Fibrinogen all reduction, its difference has statistical significance, shows the improve significantly effect of high blood lipid model rat blood rheological characteristic of the refining capsule of eliminating thrombus and removing obstruction in channels.
5, the refining capsular ligation rat postcava of eliminating thrombus and removing obstruction in channels cause thrombotest (Qin Junjia etc. Chinese Chinese medicine science and technology 1998.5 (3) 155)
Get body weight 260～330g healthy rat, all male, be divided into five groups at random by body weight, model control group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 6 dosage gastric infusion, and model control group is given equivalent distilled water, administration volume 1ml/100g body weight, successive administration 5 days, after the last administration 1 hour, each organized the anesthesia of rats by intraperitoneal injection 45mg/kg pentobarbital sodium, surgical ligation rat postcava is sewed up stomach wall 5 hours, makes rat postcava thrombus model, reopen the abdominal cavity after 5 hours, removal of thromboses is stained with the floating blood on the bolt surface of dehematizing with moistening filter paper, claims weight in wet base, put 60 ℃ of baking boxs more roasting 4 hours, the cooling back claims dry weight.T checks the significance of each group difference.The results are shown in Table 6.
The refining capsule of table 6 eliminating thrombus and removing obstruction in channels is to the thrombotic influence of rat postcava
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Thrombus weight (mg) | |
| Weight in wet base | Dry weight | |||
| Model control group | 10 | - | 33.8±26.73 | 13.9±12.56 |
| The low group of XSTLJZ | 10 | 2.91 | 14.0±12.73 * | 5.0±4.04 * |
| Organize among the XSTLJZ | 10 | 5.82 | 8.9±8.82 * | 4.0±4.22 * |
| The high group of XSTLJZ | 10 | 11.64 | 13.6±9.85 * | 5.1±3.48 * |
| The XSTL group | 10 | 1.20 | 14.0±10.11 * | 4.9±4.05 * |
With the model control group ratio
*P＜0.05
*P＜0.01
Dosage unit is g/kg
By table 6 as seen, compare with model control group, the refining capsule of eliminating thrombus and removing obstruction in channels can reduce the thrombus weight of postcava thrombus model rat, and its difference has statistical significance.Show that the refining capsule of eliminating thrombus and removing obstruction in channels has the thrombotic effect of antagonism rat postcava.
6, the refining capsular rat artery-vein bypass thrombotest of eliminating thrombus and removing obstruction in channels (the Qi Chen chief editor. herbal pharmacology research methodology Beijing: People's Health Publisher 1993.336)
Get body weight 300～350g healthy rat, all male, be divided into five groups at random by body weight, model control group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 7 dosage gastric infusion, model control group is given the equivalent distilled water, administration volume 1ml/100g body weight, successive administration 5 days, after the last administration 1 hour, each organized the anesthesia of rats by intraperitoneal injection 45mg/kg pentobarbital sodium, and it is fixing to lie on the back, separate left external jugular vein and right common carotid artery simultaneously, in polyethylene tube, put 4 of a long 6.5cm
#Surgical thread is full of the polyethylene tube of three sections connections with the heparin-saline of 50 μ/ml, then this Guan Yiduan is inserted left external jugular vein, and the other end inserts in the right common carotid artery, and open immediately bulldog clamp causes artery-vein bypass thrombus model.Accurate recording 15min, middle Herba Clinopodii takes out silk thread and weighs, and subtracting silk thread weight with gross weight is wet weight of thrombus, calculates the thrombosis suppression ratio.T checks the significance of each group difference.The results are shown in Table 7.
Table 7 disappears and examines the influence that the refining capsule of collateral dredging forms rat suppository
| Group | Number of animals (only) | Dosage (the g crude drug/kg) | Wet weight of thrombus (g) | Suppression ratio (%) |
| Model control group | 10 | - | 25.9±9.69 | |
| The low group of XSTLJZ | 10 | 2.91 | 17.4±7.06 * | 32.8 |
| Organize among the XSTLJZ | 10 | 5.82 | 14.5±10.60 * | 44.0 |
| The high group of XSTLJZ | 10 | 11.64 | 12.7±8.20 ** | 51.0 |
| The XSTL group | 10 | 1.20 | 14.8±9.7 * | 42.9 |
With blank group ratio
*P＜0.05
*P＜0.01
Dosage unit is g/kg
By table 7 as seen, compare with model control group, the refining capsule of eliminating thrombus and removing obstruction in channels can reduce the thrombus weight of artery-vein bypass thrombus model rat, and its difference has statistical significance.Show that the refining capsule of eliminating thrombus and removing obstruction in channels has the thrombotic effect of antagonism rat artery-vein bypass.
The refining capsule of eliminating thrombus and removing obstruction in channels to the influence of rabbit thrombin (Guo Shengdian etc. Chinese patent medicine 1997.19 (11) 37)
Get the healthy Japan large ear rabbit of body weight 2.1-2.9kg, male and female half and half are divided five groups at random by body weight, blank group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 8 dosage gastric infusion, the blank group is given the equivalent distilled water, administration volume 5ml/1.5kg body weight, successive administration 15 days, after the administration in the 15th day 1 hour, (anticoagulant: blood=1: 9), centrifugal 2500 changeed 15 minutes rabbit heart blood sampling 2ml, got blood plasma and tested four of thrombins by the method for test kit description: activated partial prothrombin time (APTT), Fibrinogen (FIB), prothrombin time (PT), thrombin time (TT).T checks the significance of each group difference.The results are shown in Table 8.
The refining capsule of table 8 eliminating thrombus and removing obstruction in channels is to the influence of rabbit thrombin
| Project | Group | Number of animals (only) | Dosage (g/kg) | Clotting time (s) | |
| (APTT) activated partial thromboplastin time | The blank group | 8 | - | 21.47±0.g7 | |
| The low group of XSTLJZ | 8 | 0.12 | 24.85±0.18 ** | ||
| Organize among the XSTLJZ | 8 | 0.24 | 26.35±0.90 ** | ||
| The high group of XSTLJZ | 8 | 0.48 | 28.41±0.80 ** | ||
| The XSTL group | 8 | 0.23# | 24.62±0.29 ** | ||
| (FIB) fibrinogen content | Group | Number of animals (only) | Dosage (g/kg) | Clotting time (s) | FIB(g/l) |
| The blank group | 8 | - | 11.81±0.58 | 2.54±0.17 | |
| The low group of XSTLJZ | 8 | 0.12 | 13.73±1.70 | 2.11±0.33 ** | |
| Organize among the XSTLJZ | 8 | 0.24 | 15.01±2.02 | 1.88±0.36 ** | |
| The high group of XSTLJZ | 8 | 0.48 | 15.25±1.67 | 1.76±0.22 ** | |
| The XSTL group | 8 | 0.23# | 14.84±1.12 | 1.86±0.17 ** | |
| (PT) prothrombin time | Group | Number of animals (only) | Dosage (g/kg) | Clotting time (s) | INR |
| The blank group | 8 | - | 5.95±0.42 ** | 0.29±0.03 | |
| The low group of XSTLJZ | 8 | 0.12 | 7.60±0.74 ** | 0.41±0.06 | |
| Organize among the XSTLJZ | 8 | 0.24 | 8.05±0.42 ** | 0.45±0.04 | |
| The high group of XSTLJZ | 8 | 0.48 | 8.54±0.79 ** | 0.50±0.07 | |
| The XSTL group | 8 | 0.23# | 8.25±0.73 ** | 0.48±0.06 | |
| (TT) thrombin time | Group | Number of animals (only) | Dosage (g/kg) | Clotting time (s) | |
| The blank group | 8 | - | 21.70±0.74 | ||
| The low group of XSTLJZ | 8 | 0.12 | 22.12±1.25 | ||
| Organize among the XSTLJZ | 8 | 0.24 | 22.60±1.57 | ||
| The high group of XSTLJZ | 8 | 0.48 | 23.02±0.90 | ||
| The XSTL group | 8 | 0.23# | 22.71±0.65 | ||
With blank group ratio
*P＜0.01
Dosage unit is g/kg
By table 8 as seen, with blank group ratio, the refining capsule of eliminating thrombus and removing obstruction in channels can prolong the rabbit clotting time, and its difference has statistical significance, shows that the refining capsule of inspection collateral dredging that disappears has blood coagulation resisting function.
8, the refining capsule of eliminating thrombus and removing obstruction in channels to the accumulative influence of the inductive rabbit platelet of ADP (Feng Suoan etc. Chinese herbal medicine 1997.28 (5) 291)
Get the healthy Japan large ear rabbit of body weight 2.1-2.9kg, male and female half and half are divided five groups at random by body weight, blank group, the refining basic, normal, high dosage group of capsule of eliminating thrombus and removing obstruction in channels and positive control drug XIAOSHUAN TONGLUO JIAONANG group.Each group is pressed table 8 dosage gastric infusion, the blank group is given the equivalent distilled water, administration volume 5ml/1.5kg body weight, successive administration 15 days, after the administration in the 15th day 1 hour, (anticoagulant: blood=1: 9), mixing seals rabbit heart blood sampling 3ml at once, 500 rev/mins centrifugal 5 minutes, get the ratio test glass that platelet rich plasma 300 μ l put into the band magnetic bead, residue blood mixing, 1000 rev/mins, centrifugal 8 minutes, get platelet poor plasma and put into the ratio test glass of 300 μ l, pick up counting from the platelet rich plasma taking-up, 20 minutes begin to test, test in 4 hours finishes, preheating 1 minute adds 10 μ lADP derivants, observes the platelet aggregation rate (preparation of ADP: use in 10 minutes, sodium hydrogen phosphate sodium dihydrogen phosphate preparation buffer (PH=7.4) 2mg/ml).T checks the significance of each group difference.The results are shown in Table 9.
The refining capsule of table 9 eliminating thrombus and removing obstruction in channels is to the accumulative influence of rabbit platelet
| Group | Number of animals (only) | Dosage (g/kg) | Platelet aggregation rate (%) |
| The blank group | 8 | - | 30.54+7.48 |
| The low group of XSTLJZ | 8 | 0.12 | 21.70+4.39 ** |
| Organize among the XSTLJZ | 8 | 0.24 | 19.20+5.35 ** |
| The high group of XSTLJZ | 8 | 0.48 | 1 8.62+5.20 ** |
| The XSTL group | 8 | 0.23 | 19.40+8.76 ** |
With blank group ratio
*P＜0.01
By table 9 as seen, with blank group ratio, the refining Capsules group of eliminating thrombus and removing obstruction in channels can reduce the rabbit platelet aggregation rate, and its difference has statistical significance, shows that the refining capsule of eliminating thrombus and removing obstruction in channels has the obvious suppression effect to the inductive platelet aggregation of ADP.
Above-mentioned table 1-table 9 data show, refining capsule of the present invention and xst1 contrast, its index is not less than xst1, but the dose that the refining capsule of actual dose the present invention is traditional XIAOSHUAN TONGLUO JIAONANG 1/3.
Claims (5)
1. the process for preparing medicine of an eliminating thrombus and removing obstruction in channels is characterized in that may further comprise the steps:
(1) Radix Astragali, extracting in water 1-5 time, each amount of water is 4-20 times of institute's extractions Radix Astragali dose, extraction time is 0.5-10 hour, filtration, merging filtrate is concentrated, is dried to driedly, and it is standby to be ground into fine powder;
(2) Rhizoma Chuanxiong, Ramulus Cinnamomi, Radix Salviae Miltiorrhizae extracting in water are 1-5 time, each amount of water be the Rhizoma Chuanxiong, Ramulus Cinnamomi and the Radix Salviae Miltiorrhizae crude drug amount 4-25 that are extracted doubly, each extraction time is 0.5-5 hour, filter, merging filtrate also is concentrated into the fluid extract of relative density 1.05-1.25, adds the 1-30 10-99.5% ethanol doubly of the fluid extract total amount of extracting while hot, abundant stirring, left standstill 5-96 hour, get supernatant, reclaim ethanol, be dried to dried, be ground into fine powder, standby;
(3) Rhizoma Alismatis adds 10-99.5% ethanol extraction 1-5 time, each alcohol adding amount be the Rhizoma Alismatis crude drug amount extracted 3-25 doubly, each extraction time is 0.5-5 hour, filters, merging filtrate reclaims ethanol and also is concentrated into the fluid extract of water content below 12%, and is standby;
(4) Fructus Crataegi, Flos Sophorae add 10-99.5% ethanol extraction 1-5 time, each alcohol adding amount be the Fructus Crataegi of being extracted, Flos Sophorae crude drug amount 3-25 doubly, each extraction time is 0.5-5 hour, filter, merging filtrate reclaims ethanol and is concentrated into relative density 1.01-1.25 liquid or extractum, adds mineral acid 10-10000ml while hot, 40-100 ℃ is incubated 10-600 minute, left standstill 5-96 hour, abandoning supernatant, precipitation adds and is washed to PH2-7, be dried to driedly, it is standby to be ground into fine powder;
(5) Radix Notoginseng is pulverized, add the 10-99.5% ethanol extraction 1-5 time, each alcohol adding amount be the Radix Notoginseng crude drug amount extracted 3-25 doubly, each extraction time is 0.5-5 hour, filter, merging filtrate reclaims ethanol to relative density 1.01-1.30 liquid, adopt absorption with macroporous adsorbent resin, with resin with extract medical material gross weight 0.5-20: the ratio upper prop of 1-10,2-30 times of water yield water elution discards water elution liquid, continuous 2-30 10-99,5% ethanol elution doubly with medical material weight, collect ethanol elution, reclaim ethanol, be dried to dried, be ground into fine powder, standby;
(6) Radix Curcumae, Radix Aucklandiae powder are broken into coarse powder, extracted volatile oil in steam distillation 1-15 hour, or employing supercritical extraction, extract pressure 2-30MPa, temperature 0-100 ℃, extraction ratio 1-8%, get above extract respectively, doubly measure cyclodextrin with the 2-30 of extract and carry out enclose, lyophilization or 35-50 ℃ is dried to dried, standby;
(7) with gained dry powder and fluid extract among the step 1-6 and Borneolum Syntheticum mix homogeneously, add any or multiple blended medicinal diluent, base unit weight is dry powder and fluid extract weight 0.1-1.5 a times, mix thoroughly, be ground into fine powder or make the granule of 0.2-3mm, make various pharmaceutical preparatioies after making pharmaceutical preparation or coating then.
2. in accordance with the method for claim 1, it is characterized in that the described mineral acid of step (4) comprises any acid of hydrochloric acid, sulphuric acid, nitric acid.
3. in accordance with the method for claim 1, it is characterized in that the described macroporous resin of step (5) comprises any resin in AB-8 type macroporous resin, D101 type macroporous resin, the HP-20 type macroporous resin.
4. in accordance with the method for claim 1, it is characterized in that the described inclusion method of step (6) comprises saturated water solution method, supercritical ultrasonics technology, polishing, freeze-drying or spray drying method.
5. in accordance with the method for claim 1, it is characterized in that the described medicinal diluent of step (7) comprise starch, dextrin, Icing Sugar, mannitol and comprise the oxide of aluminum, magnesium, calcium or the antiacid material of hydroxide in one or more blended medicinal diluents.
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| CN113230347A (en) * | 2021-06-01 | 2021-08-10 | 山东省千佛山医院 | Traditional Chinese medicine composition for treating cerebral thrombosis |
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