CN1686423A - Medicinal composition containing scutellaria glucoside and bupleurum and its preparation method - Google Patents
Medicinal composition containing scutellaria glucoside and bupleurum and its preparation method Download PDFInfo
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- CN1686423A CN1686423A CN 200510067854 CN200510067854A CN1686423A CN 1686423 A CN1686423 A CN 1686423A CN 200510067854 CN200510067854 CN 200510067854 CN 200510067854 A CN200510067854 A CN 200510067854A CN 1686423 A CN1686423 A CN 1686423A
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- 239000000203 mixture Substances 0.000 title claims description 19
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- 229930182478 glucoside Natural products 0.000 title 1
- 150000008131 glucosides Chemical class 0.000 title 1
- 239000003814 drug Substances 0.000 claims abstract description 29
- 239000000284 extract Substances 0.000 claims abstract description 15
- 238000000034 method Methods 0.000 claims abstract description 15
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- 239000008194 pharmaceutical composition Substances 0.000 claims description 29
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- IKIIZLYTISPENI-ZFORQUDYSA-N baicalin Chemical compound O1[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1OC(C(=C1O)O)=CC2=C1C(=O)C=C(C=1C=CC=CC=1)O2 IKIIZLYTISPENI-ZFORQUDYSA-N 0.000 claims description 25
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- BHQCQFFYRZLCQQ-UHFFFAOYSA-N (3alpha,5alpha,7alpha,12alpha)-3,7,12-trihydroxy-cholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 BHQCQFFYRZLCQQ-UHFFFAOYSA-N 0.000 description 1
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- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical compound C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 description 1
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- KXGVEGMKQFWNSR-UHFFFAOYSA-N deoxycholic acid Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 KXGVEGMKQFWNSR-UHFFFAOYSA-N 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
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- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
An orally taken Chinese medicine for treating influenze and upper respiratory tract infection features that it contains proportionally scutelloside, the extract of bupleurum root, artificial bezoar and medicinal carrier. Its preparing process is also disclosed.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly, relate to and a kind ofly be used for the treatment of influenza or go up the heating that sense causes, the pharmaceutical preparation of symptoms such as pain.
Background technology
The heating that influenza or last sense cause, pain etc. are many diseases that caused by pathogenic bacteria poison or bacterial infection.This disease is human commonly encountered diseases, frequently-occurring disease, how because resistance of human body reduces, is subjected to due to pathogenic bacteria poison or the bacterial infection,
At present the medicine of this class disease of treatment is many, but it is few to form the influenza that preparation for treating virus causes with Chinese medicine.。
The heating that current treatment influenza or last sense cause, there are the following problems in the pharmaceutical preparation of symptoms such as pain:
1. the chemicals side effect is bigger, draws symptoms such as drowsiness, tired, weak, dizzy and xerostomia after some common drug patient takes.That have even cause serious adverse effects such as leukopenia.
2. influenza or go up that sense is many to be caused by viral infection, but the medicine of the viral infection of Chinese medicine preparation treatment at present is few, often is symptomatic treatment.
3. the virus of Chinese medicine preparation treatment at present causes influenza or goes up the heating that sense causes, the pain effect is slower.Baikal skullcap root has heat clearing and damp drying, the effect of eliminating fire and detoxication, bupleurum Chinese also has the analgesic effect of delivering, both are share preparation be used for the treatment of the anemopyretic cold medicine, existing in the prior art report, a kind of Chinese medicine oral liquid by Radix Scutellariae and Radix Bupleuri preparation is for example disclosed among the CN1049600C, but this oral liquid is by almost the Radix Scutellariae and the Radix Bupleuri of equivalent obtain fully through the decocting boiling, macromolecular compound such as contained water soluble ingredient tannin is more in the gained oral liquid, form precipitation easily, cause the oral liquid instability, be difficult to long preservation, therefore, needs add antiseptic such as sodium benzoate; And because this oral liquid boils by decocting and obtains, and active constituent content is low, reach required drug effect, patient need take in a large number, has increased toxic and side effects, and is difficult to be accepted by patient.
Directly carry out combined preparation medicine, particularly solid preparation, yet there are no report with baicalin and Radix Bupleuri extract.The artificial Calculus Bovis is mainly contained cholic acid, bilirubin, has heat-clearing and toxic substances removing, the effect of enhancing immunity, and the medicine with baicalin, Radix Bupleuri and artificial Calculus Bovis's combined preparation does not appear in the newspapers yet.
Summary of the invention
The purpose of this invention is to provide a kind of virus that is used for the treatment of causes influenza or goes up the heating that sense causes; the Chinese medicine preparation of pain; this pharmaceutical composition is an effective ingredient with radix scutellariae extract or baicalin, Radix Bupleuri; randomly also contain the artificial Calculus Bovis as effective ingredient; wherein; baicalin is 1～4 part by weight, and Radix Bupleuri (raw material) is 5～50 parts,, the artificial Calculus Bovis is 0～5 part.Promptly; pharmaceutical composition provided by the invention can be that active component prepares by baicalin and Radix Bupleuri extract, in order to bring into play drug effect better, also can add the artificial Calculus Bovis in said medicine; prepare by baicalin the pharmaceutical composition that Radix Bupleuri extract and artificial Calculus Bovis form.
Preferably, contain 1～2 part of baicalin by weight in the pharmaceutical composition provided by the invention, by Radix Bupleuri extract and 1～2 part of artificial Calculus Bovis of 10～20 parts of Radix Bupleuri preparations.
More preferably, in a specific embodiments of the present invention, aforementioned pharmaceutical compositions contains 9 weight portion baicalins, 100 weight portion Radix Bupleuri (raw material) and 10 weight portion artificial Calculus Boviss.
Radix Bupleuri of the present invention can be by the preparation of following method: with 50%～80% ethanol lixiviate one or many, relative density was 1.15～1,25 when filtrate was concentrated into 50 ℃ of heat surveys with Radix Bupleuri.For example Radix Bupleuri (being preferably the Radix Bupleuri decoction pieces that cooks) is pulverized and is added 3～6 times of amounts and (please illustrate by weight or by volume?) 50%～80% ethanol lixiviate of (being preferably 5 times of amounts), wherein ethanol is preferably 60% ethanol water; Randomly 2) filter, lixiviate is once extremely repeatedly again to add 3～6 times of amounts (being preferably 4 times of amounts) 50%～80% ethanol (being preferably 60% ethanol water) in medicinal residues; 3) merge extractive liquid,, relative density is 1.15～1.25 when being evaporated to 50 ℃ of heat surveys, preferably being concentrated into relative density is 1.20～1.25, obtains Radix Bupleuri extractum.
Pharmaceutical composition of the present invention can be prepared to various dosage forms, can be oral formulations, also can be non-oral formulation.Wherein oral formulations can be an oral solid formulation, also can be oral liquid, and oral solid formulation can be capsule, tablet, granule, dispersible tablet, effervescent tablet, chewable tablet, soft capsule or pill; Oral liquid can be oral liquid, mixture or syrup etc.For example in an embodiment preferred of the present invention, pharmaceutical composition of the present invention is a capsule, and in another preferred such scheme, pharmaceutical composition of the present invention is a tablet.Non-oral formulation can be an injection, preparation capable of permeating skin, or spray etc., optimizing injection.Injection can be an infusion solutions, primary infusion, and little liquid drugs injection also can be a lyophilized injectable powder.
It should be understood by one skilled in the art that needs, in pharmaceutical composition of the present invention, often need to add again an amount of pharmaceutical carrier according to preparation.The kind of pharmaceutical carrier and consumption without limits, those of ordinary skills can freely select as required.For example pharmaceutical carrier can be starch (corn starch, potato starch etc.), Pulvis Talci, lactose, sucrose, calcium stearate, sodium stearate, glycerol, ethylene glycol or the like (can also give an example).Wherein be preferably starch.
In addition, in the pharmaceutical composition of the present invention, can also add an amount of additive as required.For example (can also give an example) such as correctives, spice, solubilizing agents.
Another object of the present invention provides the preparation method of aforementioned pharmaceutical compositions, and this method comprises 1) Radix Bupleuri is pulverized and is added 50%～80% ethanol lixiviate one or many of 3～6 times of amounts; Relative density is 1.15～1.25 when 2) extracting solution being evaporated to 50 ℃ of heat surveys, obtains Radix Bupleuri extractum; 3) with 2) gained extractum randomly mixes with the artificial Calculus Bovis, and drying is pulverized; 4) add baicalin and also randomly add an amount of pharmaceutical carrier, mix homogeneously, drying is granulated; 5) make required preparation as required.
In another concrete such scheme, the inventive method comprises 1) 50%～80% ethanol lixiviate of Radix Bupleuri being pulverized and adding 3～6 times of amounts; 2) filter twice of the lixiviate again of 3～6 times of amounts of medicinal residues reuse, 50%～80% ethanol; 3) merge extractive liquid,, relative density is 1.15～1.25 when being evaporated to 50 ℃ of heat surveys, is preferably 1.20～1.25, obtains Radix Bupleuri extractum; 4) with 3) gained extractum randomly mixes with the artificial Calculus Bovis, and drying is pulverized; 5) add Radix Scutellariae and also randomly add an amount of pharmaceutical carrier, mix homogeneously, drying is granulated; 6) make required preparation as required.
Preferably, used ethanol is 60% ethanol step 1) and 2 in the inventive method).More preferably, in the step 1) used ethanol be the 60% ethanol lixiviate of 5 times of amounts once, step 2) for measuring 60% ethanol lixiviate twice with 4 times.
Be appreciated that when the preparation Radix Bupleuri extractum, the ethanol water of the ethanol respective concentration that is added during lixiviate, its addition is in weight/volume, that is and, for 1 weight portion Radix Bupleuri medical material, the alcoholic solution that adds the respective volume multiple extracts.Particularly, if the weight of the Radix Bupleuri medical material that is extracted is 500 grams, then adds 4 times of amount 60% ethanol and be meant adding 2000mL60% ethanol water.
The baicalin that uses among the present invention can extract by known method with baikal skullcap root and prepare, and also can buy to obtain, and baicalin is a pale yellow powder, bitter in the mouth, purity be 85% or more than, preferred 90% or more than, more preferably wherein content of baicalin is 95%.Umbelliferae bupleurum (Bupleurum chinenseDC) also is a Chinese medicine, can use its herb, but preferably extracts Radix Bupleuri extract with its dry root.The artificial Calculus Bovis can buy from 25 tame enterprises such as bass Europe, Shanghai pharmaceutcal corporation, Ltds, is yellow loose powder, and bitter in the mouth is little sweet.
Radix Bupleuri adopts the ethanol extraction, and extracting with the saponin is Main Ingredients and Appearance alcohol soluble substance, has significantly reduced wherein compositions such as water solublity tannin, has improved curative effect, has reduced dose, makes things convenient for patient to take, and has improved stability of drug simultaneously, is beneficial to long term storage.
Most preferably, the invention provides a kind of capsulae anticoryzae (being also referred to as bilingual capsule), selected following composition of raw materials for use by baicalin, Radix Bupleuri and artificial Calculus Bovis's preparation:
Baicalin 45～135g, Radix Bupleuri 500～1500g, artificial Calculus Bovis 50～150g and starch 35～105g.
The consumption of above-mentioned each medicine components has been represented the proportionate relationship between them, can carry out expansion at double as required or dwindle in actual production, and this all belongs in protection scope of the present invention, can both show the pharmacological effect of its expection.Above-mentioned flavour of a drug be according to folk remedy in conjunction with clinical experience, the pharmacological experimental data of science in addition, comprehensive Design is formed, can bring into play pharmacological action separately, can play mutual synergism again, the pharmacology action effect is increased, can guarantee that again medicine does not change in storage.This product is through the clinical experiment result, and treatment virus causes influenza or go up the heating that sense causes, effective percentage such as pain reach 95%, is currently to cause influenza or go up the heating that sense causes, the better medicine of pain with Chinese medicine preparation treatment virus.This product is not only taken stopgap measures, and also effect a permanent cure, and effect is very fast.And as a comparison, the described oral liquid that the present inventor prepares by disclosed method among the CN1049600C is (because this oral liquid is ratified without Drug Administration, can not be used for clinical trial, therefore can't obtain clinical testing data), after placing for 1 week, room temperature just begins precipitation.Pharmaceutical composition of the present invention, significant change, steady quality do not take place in efficacy component in two years of storage.Every test item is all up to specification.
Pharmaceutical composition of the present invention is to be that raw material extracts the baicalin obtain with the natural plant Radix Scutellariae; Radix Bupleuri is that the raw material extraction obtains extractum and the artificial Calculus Bovis forms.This medicine has the function of heat-clearing and toxic substances removing.Be used for the treatment of influenza or go up the heating that sense causes, diseases such as pain.The reasonable compatibility of pharmaceutical composition of the present invention has reached special medical effect, and it is that each single composition institute is inaccessiable.
Product clinical testing data of the present invention and method
Test method:
1, randomized controlled clinical trial
2, select outpatient service and inpatient totally 200 examples, be divided into treatment group and matched group at random, each 100 example.
3, contrast medicinal GANMAO QINGRE JIAONANG, two cream packing.
4, three times on the oral one, one time 3, during taking this medicine, withdraw any medicine relevant with this disease.
5,3 days is a course of treatment, observes a course of treatment altogether.Before the treatment, body temperature, symptom variation are observed in the treatment back in the treatment.
6, completely learn method, group data is done X 2 test, measurement data is made the inspection level data and is done Ridit check.
Clinical testing data
1, each center test case situation
Each center case of table 1-1 distributes
| Center 01 02 03 04 05 adds up to | Go into to organize case load | Case load comes off | Reject case load | Finish case load | ||||||||||||
| The A group | The B group | The C group | Add up to | The A group | The B group | The C group | Add up to | The A group | The B group | The C group | Add up to | The A group | The B group | The C group | Add up to | |
| ??24 ??24 ??24 ??24 ??24 ??120 | ??24 ??24 ??24 ??24 ??24 ??120 | ??24 ??24 ??24 ??24 ??24 ??120 | ??72 ??72 ??72 ??72 ??72 ??360 | ??0 ??3 ??0 ??0 ??0 ??3 | ??1 ??5 ??0 ??0 ??2 ??8 | ??1 ??4 ??0 ??0 ??2 ??7 | ??2 ??12 ??0 ??0 ??4 ??18 | ??1 ??0 ??0 ??0 ??0 ??1 | ??2 ??0 ??0 ??0 ??0 ??2 | ??0 ??0 ??0 ??0 ??0 ??0 | ??3 ??0 ??0 ??0 ??0 ??3 | ??23 ??21 ??24 ??24 ??24 ??116 | ??21 ??19 ??24 ??24 ??22 ??110 | ??23 ??20 ??24 ??24 ??22 ??113 | ??67 ??60 ??72 ??72 ??68 ??339 | |
Annotate: Huaxi Hospital Attached to Sichuan Univ 01, attached first hospital 02 of Hunan University of Traditional Chinese Medicine, attached second hospital 03 of Hunan University of Traditional Chinese Medicine, attached first hospital 04 of Guiyang College of Traditional Chinese Medicine, Hainan Province institute of traditional Chinese medicine 05.
Each center statistics case load of table 1-2
| The center | Meet the scheme collection | The intentional analysis collection | The safety collection | |||||||||
| The A group | The B group | The C group | Add up to | The A group | The B group | The C group | Add up to | The A group | The B group | The C group | Add up to | |
| ????01 ????02 ????03 ????04 ????05 | ????23 ????21 ????24 ????24 ????24 | ????21 ????49 ????24 ????24 ????22 | ????23 ????20 ????24 ????24 ????22 | ????67 ????60 ????72 ????72 ????68 | ????23 ????22 ????24 ????24 ????24 | ????22 ????21 ????24 ????24 ????22 | ????23 ????20 ????24 ????24 ????22 | ????68 ????63 ????72 ????72 ????68 | ????24 ????24 ????24 ????24 ????24 | ????24 ????24 ????24 ????24 ????24 | ????24 ????24 ????24 ????24 ????24 | ????72 ????72 ????72 ????72 ????72 |
| Add up to | ????116 | ??110 | ????113 | ????339 | ????117 | ????113 | ????113 | ????343 | ????120 | ????120 | ????120 | ????360 |
2, MAIN OUTCOME MEASURES result and analysis
Table 3-1 comprehensive therapeutic effect is analyzed
| Group | ??n | Recovery from illness | Produce effects | Effectively | Invalid | Total obvious effective rate | Total effective rate | ||||
| ??n | ??％ | ??n | ????％ | ????n | ????％ | ????n | ??％ | ||||
| A group B group C group | ??116 ??110 ??113 | ??50 ??46 ??29 | ??43.10 ??41.82 ??25.66 | ??50 ??50 ??53 | ??43.10 ??45.45 ??46.90 | ????13 ????11 ????30 | ????11.21 ????10.00 ????26.55 | ????3 ????3 ????1 | ??2.59 ??2.73 ??0.88 | ?86.20 ?87.27 ?72.59 | ?97.41 ?97.27 ?99.12 |
X
2＝12.911??P＝0.0016
Table 3-2 tcm symptom efficacy analysis
| Group | ??n | Recovery from illness | Produce effects | Effectively | Invalid | Total obvious effective rate | Total effective rate | ||||
| ??N | ?％ | ??n | ?％ | ????n | ????％ | ????n | ??％ | ||||
| The A group | ??116 | ????50 | ?46.55 | ??50 | ?43.10 | ????9 | ????7.76 | ????3 | ???2.59 | ?89.65 | ?97.41 |
| B group C group | ?110 ?113 | ?48 ?29 | ?43.64 ?25.66 | ?46 ?53 | ?41.82 ?46.90 | ????13 ????30 | ????11.00 ????26.55 | ????3 ????1 | ??2.73 ??0.88 | ??85.46 ??72.59 | ??97.27 ??99.12 |
X
2＝16.572??P＝0.0003
Mean body temperature relatively before and after the table 3-3 treatment
| Group | ??n | X ± S before the treatment | Treatment back x ± S | Difference x ± S | ????F | ????P |
| A group B group C group | ?? ??116 ? ? ??110 ? ? ??113 | ??37.85± ????0.41 ??37.88± ? ????0.38 ??37.95± ? ????0.43 | ??36.82± ? ????0.42 ??36.84± ? ????0.35 ??36.89± ? ????0.48 | ????1.031± ? ????????0.432 ????1.050± ? ????????0.424 ????1.028± ? ????????0.398 | ? ? ? ?? ??0.09 | ? ? ? ?? ??0.915 |
The cardinal symptom degree relatively before and after the table 3-4 treatment
| Symptom heating slight chill pharyngalgia | Group A group B group C group A group B group C group | ?n ? ?? ?116 ?110 ?113 ?116 ?110 ?113 | Before controlling | In controlling | After controlling | |||||||||
| Do not have 000000 | Light by 48 36 42 69 54 59 | In 52 57 49 37 41 44 | Weigh 16 17 22 10 15 10 | Do not have 69 58 61 18 21 17 | Light by 38 43 38 91 72 80 | In 99 13 7 17 14 | Weigh 001002 | Do not have 108 101 93 81 73 59 | Light by 55 18 34 37 49 | In 341104 | Weigh 001001 | |||
Heating slight chill: in the group: A group: Z1=8.547 P1=0.00; Z2=9.526 P2=0.00
B group: Z1=9.179 P1=0.00; Z2=9.288 P2=0.00
C group: Z1=9.559 P1=0.00; Z2=9.427 P2=0.00
Between group: Z1=1.324 P1=0.516
Z2＝7.479??P2＝0.024
In the pharyngalgia group: A group: Z1=7.761 P1=0.00; Z2=9.305 P2=0.00
B group: Z1=8.239 P1=0.00; Z2=9.289 P2=0.00
C group: Z1=7.464 P1=0.00; Z2=9.139 P2=0.00
Between group: Z1=1.520 P1=0.468
Z2＝9.573?P2＝0.0083
Body of the tongue relatively before and after the table 3-5 treatment
| Group | ????n | Before controlling | After controlling | In the group | Between group | |||
| Normally | Red | Normally | Red | ????P * | ??X 2 | ????P | ||
| A group B group C group | ??116 ??110 ??113 | ????4 ????4 ????4 | ????112 ????106 ????109 | ????82 ????76 ????66 | ????34 ????34 ????47 | ????0.00 ????0.00 ????0.00 | ?4.512 | ????0.105 |
Tongue fur relatively before and after the table 3-6 treatment
| Group | ????n | Before controlling | After controlling | In the group | Between group | |||||
| Normally | The book Huang | Other | Normally | The book Huang | Other | ??P * | ??X2 | ??P | ||
| A group B group C group | ?116 ?110 ?113 | ?7 ?8 ?8 | ?109 ?102 ?105 | ?0 ?0 ?0 | ?80 ?77 ?75 | ?36 ?33 ?38 | ?0 ?0 ?0 | ?0.00 ?0.00 ?0.00 | ? ??0.362 | ? ??0.834 |
Pulse condition relatively before and after the table 3-7 treatment
| Group | ??n | Before controlling | After controlling | In the group | P between group * | |||
| Normally | Floating number | Normally | Floating number | ????X 2 | ????P | |||
| A group B group C group | ??116 ??110 ??113 | ????34 ????36 ????32 | ????82 ????74 ????81 | ????111 ????105 ????95 | ????5 ????5 ????18 | ? ? ????71.34 | ????0.00 ????0.00 ????0.00 | ? ???0.003 |
Virus detects relatively before and after the table 3-8 treatment
| Group | ??n | Before controlling | After controlling | In the group | Between group | ||||
| Negative (%) | Positive (%) | Negative (%) | Positive (%) | ?Z | ??P | ?X 2 | ?P | ||
| A group B group C group | ?93 ?89 ?94 | 65(69.89) 59(66.29) 64(68.82) | 28(30.11) 30(23.71) 29(68.82) | ??89(95.70) ??86(96.63) ??86(31.18) | 4(4.30) 3(3.37) 8(7.53) | ?4.899 ?5.196 ?4.690 | ??0.00 ??0.00 ??0.00 | ? ?1.807 | ? ?0.405 |
The onset time distribution of table 3-9-1 body temperature is (h) relatively
| Group | ??n | ???～12 | ???～24 | ???～48 | ???～72 | Not onset | ??X 2 | ????P |
| A group B group C group | ??116 ??110 ??113 | ????83 ????86 ????77 | ????16 ????13 ????18 | ????9 ????6 ????10 | ????1 ????1 ????1 | ????7 ????7 ????7 | ? ??1.445 | ? ??0.695 |
Table 3-9-2 mean body temperature onset time comparison (h)
| Group | ????n | ?? x±S | ????F | ????P |
| A group B group C group | ????109 ????105 ????107 | ??10.29±11.80 ??9.67±8.80 ??11.73±13.32 | ? ????0.90 | ? ????0.41 |
The analgesic time of table 3-10-1 distributes compares (h)
| Group | ??n | ??～12 | ??～24 | ??～48 | ??～72 | Not onset | ??X 2 | ???P |
| A group B group | ??116 ??110 | ??53 ??37 | ??20 ??20 | ??15 ??22 | ??7 ??14 | ????21 ????17 | ??9.32 | ???0.32 |
| The C group | ????113 | ????44 | ????19 | ????16 | ????8 | ????26 |
The analgesic time ratio of table 3-10-2 mean body temperature is (h)
| Group | ????n | ????? x±S | ????F | ????P |
| A group B group C group | ????106 ????95 ????90 | ????25.59±27.92 ????26.17±21.98 ????21.97±20.72 | ? ????0.84 | ? ????0.43 |
To sum up data shows, the present invention is feasible, effective, practical.
Embodiment
Provide the enforcement embodiments of the invention below, but be appreciated that these embodiment only are in order to further specify the present invention, and do not limit the present invention in any way.
Embodiment:
Embodiment 1
(1) prescription: baicalin: 135g, Radix Bupleuri: 1500g, artificial Calculus Bovis: 150g, starch: 80g.
(2) technology: Radix Bupleuri is ground into coarse powder, puts in the diafiltration tube, adds 5 times of amount 60% ethanol and stirs, and extracting solution is emitted in room temperature lixiviate two days.4 times of amounts of medicinal residues reuse, 60% ethanol extraction secondary; each two days, merge extractive liquid,, distilling under reduced pressure gets Radix Bupleuri extractum (relative density 1.20～1.25; 50 ℃ of heat are surveyed) mix with the artificial Calculus Bovis; drying under reduced pressure is ground into fine powder, adds baicalin fine powder and appropriate amount of starch; granulate; drying, encapsulated, obtain 1500 capsules.
Embodiment 2
(1) prescription: baicalin: 50g, Radix Bupleuri: 250g, starch: 15g.
(2) technology: the Radix Bupleuri decoction pieces is ground into coarse powder, puts in the diafiltration tube, adds 5 times of amount 65% ethanol and stirs, and extracting solution is emitted in room temperature lixiviate two days.4 times of amounts of medicinal residues reuse, 65% ethanol extraction secondary, each two days, merge extractive liquid,, distilling under reduced pressure gets Radix Bupleuri extractum (relative density 1.20～1.25,50 ℃ of heat are surveyed), drying under reduced pressure is ground into fine powder, adds baicalin fine powder and appropriate amount of starch, granulate, drying, tabletting obtains 600 bilingual.
Embodiment 3
(1): prescription: baicalin: 50g, Radix Bupleuri: 2500g, artificial Calculus Bovis: 250g, starch: 120g.
(2): technology: the Radix Bupleuri decoction pieces is ground into coarse powder, puts in the diafiltration tube, add 6 times of amount 75% ethanol and stir, extracting solution is emitted in room temperature lixiviate two days.4 times of amounts of medicinal residues reuse, 75% ethanol extraction secondary, each two days, merge extractive liquid,, distilling under reduced pressure gets Radix Bupleuri extractum (relative density 1.20～1.25; 50 ℃ of heat are surveyed) mix with the artificial Calculus Bovis, drying under reduced pressure is ground into fine powder, adds Radix Scutellariae fine powder and appropriate amount of starch; granulate, drying, encapsulated.
Embodiment 4
(1) prescription: baicalin: 90g, Radix Bupleuri: 1000g, water for injection: surplus.
(2) technology: the Radix Bupleuri decoction pieces is ground into coarse powder, puts in the diafiltration tube, add 5 times of amount 65% ethanol and stir, extracting solution is emitted in room temperature lixiviate two days.4 times of amounts of medicinal residues reuse, 65% ethanol extraction secondary, each two days, merge extractive liquid,, distilling under reduced pressure gets Radix Bupleuri extractum (relative density 1.20～1.25,50 ℃ of heat are surveyed), drying under reduced pressure is ground into fine powder, add in the 200mL distilled water for injection, stir and make the extractum dissolving, placement is spent the night, filter, other gets baicalin and is dissolved in the 200mL distilled water for injection, stirs, filter, two kinds of filtrates are merged, add distilled water for injection to 1000mL, sterilization, fill, promptly.
Claims (14)
1. pharmaceutical composition, it is characterized in that this pharmaceutical composition contain by weight 1～4 part of baicalin, by Radix Bupleuri extract, 0～5 part of artificial Calculus Bovis of 5～50 parts of Radix Bupleuri preparations.
2. according to the pharmaceutical composition of claim 1, it is characterized in that this pharmaceutical composition also contains an amount of pharmaceutical carrier.
3. according to the pharmaceutical composition of claim 2, wherein pharmaceutical carrier is a starch.
4. according to the pharmaceutical composition of claim 3, wherein said composition contains 1～2 part of baicalin by weight, by Radix Bupleuri extract and 1～2 part of artificial Calculus Bovis of 10～20 parts of Radix Bupleuri preparations.
5. according to the pharmaceutical composition of claim 4, wherein said composition contains 9 weight portion baicalins, by extract and 10 parts of weight artificial Calculus Boviss of 100 weight portion Radix Bupleuri preparation.
6. according to pharmaceutical composition any in the claim 1～5, wherein Radix Bupleuri extract prepares by following method: with 50%～80% ethanol lixiviate one or many, relative density was 1.15～1,25 when filtrate was concentrated into 50 ℃ of heat and surveys with Radix Bupleuri.
7. according to pharmaceutical composition any in the claim 1～6, wherein this pharmaceutical composition is solid orally ingestible, liquid oral medicine or injection.
8. according to the pharmaceutical composition of claim 7, wherein the Peroral solid dosage form solid preparation is capsule, tablet, granule or pill, dispersible tablet, effervescent tablet, chewable tablet or soft capsule.
9. according to the pharmaceutical composition of claim 7, wherein liquid oral medicine is mixture or oral liquid.
10. according to the pharmaceutical composition of claim 7, wherein injection is transfusion or little aqueous injection or lyophilized injectable powder.
11. prepare the method for the described pharmaceutical composition of claim 1, this method comprises 1) Radix Bupleuri pulverized and adds 50%～80% ethanol lixiviate one or many of 3～6 times of amounts; Relative density is 1.15～1.25 when 2) extracting solution being evaporated to 50 ℃ of heat surveys, obtains Radix Bupleuri extractum; 3) with 2) gained extractum randomly mixes with the artificial Calculus Bovis, and drying is pulverized; 4) add baicalin and also randomly add an amount of pharmaceutical carrier, mix homogeneously, drying is granulated; 5) make required preparation as required.
12. according to the method for claim 11, wherein used ethanol is 60% ethanol in the step 1).
13. according to the method for claim 11, wherein step 2) in to be concentrated into relative density be 1.20～1.25.
14. according to the method for claim 12, wherein step 1) is for measuring 60% ethanol lixiviate once, twice of 4 times of amounts of reuse, 60% ethanol lixiviate with 5 times.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100420456C (en) * | 2006-03-14 | 2008-09-24 | 北京国丹药物技术开发有限公司 | Compounded Radix Bupleuri enema preparation and preparing method |
| CN102641333A (en) * | 2012-04-11 | 2012-08-22 | 河南灵佑药业有限公司 | Sugar-free type Chaihuang granules and preparing method thereof |
| CN102106884B (en) * | 2009-12-25 | 2013-08-21 | 财团法人工业技术研究院 | Medicinal composition having immunity-regulating function |
| US8597693B2 (en) | 2010-07-01 | 2013-12-03 | Industrial Technology Research Institute | Pharmaceutical composition with immunomodulating function |
| CN106309522A (en) * | 2016-08-24 | 2017-01-11 | 扬子江药业集团上海海尼药业有限公司 | Chaifei Qingning capsule and preparing method thereof |
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2005
- 2005-04-28 CN CNB2005100678542A patent/CN100512796C/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100420456C (en) * | 2006-03-14 | 2008-09-24 | 北京国丹药物技术开发有限公司 | Compounded Radix Bupleuri enema preparation and preparing method |
| CN102106884B (en) * | 2009-12-25 | 2013-08-21 | 财团法人工业技术研究院 | Medicinal composition having immunity-regulating function |
| US8597693B2 (en) | 2010-07-01 | 2013-12-03 | Industrial Technology Research Institute | Pharmaceutical composition with immunomodulating function |
| CN102641333A (en) * | 2012-04-11 | 2012-08-22 | 河南灵佑药业有限公司 | Sugar-free type Chaihuang granules and preparing method thereof |
| CN106309522A (en) * | 2016-08-24 | 2017-01-11 | 扬子江药业集团上海海尼药业有限公司 | Chaifei Qingning capsule and preparing method thereof |
| CN106309522B (en) * | 2016-08-24 | 2017-07-28 | 扬子江药业集团上海海尼药业有限公司 | Clear Yiganning capsule of bavin a kind of reed mentioned in ancient books and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100512796C (en) | 2009-07-15 |
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