CN100427117C - Chinese proprietary medicine - Google Patents

Chinese proprietary medicine Download PDF

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CN100427117C
CN100427117C CNB2005100409086A CN200510040908A CN100427117C CN 100427117 C CN100427117 C CN 100427117C CN B2005100409086 A CNB2005100409086 A CN B2005100409086A CN 200510040908 A CN200510040908 A CN 200510040908A CN 100427117 C CN100427117 C CN 100427117C
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cyclodextrin
shuanghuanlian
chinese medicine
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CN1720969A (en
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任勇
董祥玉
殷志敏
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Nanjing Normal University
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Nanjing Normal University
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Abstract

The present invention relates to a cyclodextrin molecular composition of traditional Chinese medicine Shuanghuanglian, which comprises traditional Chinese medicine Shuanghuanglian and cyclodextrin, wherein the traditional Chinese medicine Shuanghuanglian is the dry powder of medicinal materials or crude extracts of medicinal materials; the mass ratio of the dry powder of medicinal materials of the traditional Chinese medicine Shuanghuanglian to beta-cyclodextrin is from 1: 6 to 1: 3, and the mass ratio of the traditional Chinese medicine Shuanghuanglian to the cyclodextrin is from 1: 10 to 1: 3; the cyclodextrin is beta-cyclodextrin or a hydroxypropyl-beta-cyclodextrin derivative of the beta-cyclodextrin, or SBE-beta-cyclodextrin. The present invention has an optimized scheme that a mixture with multiple effective ingredients containing no cyclodextrin is obtained via the de-inclusion of inclusion compounds. The present invention also provides a preparation method for the composition. In the present invention, the beta-cyclodextrin is combined with a specific structure and medicinal ingredients to form a supermolecular inclusion compound in a molecular recognition mode; inclusion ingredients can be easily separated from non-inclusion ingredients, and therefore, the purpose of extracting active ingredients can be achieved, which is obviously different from a traditional chromatographic technique and a principle method for solution distribution and extraction.

Description

The cyclodextrin supermolecular composition of Chinese medicine SHUANGHUANLIAN
Technical field
The present invention relates to a kind of herbal mixture extract, be specifically related to a kind of cyclodextrin supermolecular composition of Chinese medicine SHUANGHUANLIAN, and this preparation of compositions method.
Background technology
SHUANGHUANLIAN is the herbal mixture of Flos Lonicerae, Radix Scutellariae, Fructus Forsythiae compatibility, and China's pharmacopeia (version in 2000) preparation mainly contains dosage forms such as oral liquid, granule, suppository, injection at present.SHUANGHUANLIAN has heat-clearing and toxic substances removing, declares the function effect of wind heat clearly, and the clinical affection due to external wind and heat that is used for evil is defended at lung, dominance of heat in the interior, and card is seen heating, the cold or aversion to cold not of micro evil wind, cough tachypnea, the yellow skin of coughing up phlegm, the red and swollen pain of pharynx; Acute upper respiratory tract infection, acute bronchitis, acute tonsillitis, light-duty pneumonia are seen above-mentioned patient.A large amount of pharmacological researches prove, SHUANGHUANLIAN has many pharmacologically actives such as antiinflammatory, antibiotic, antiviral, antiendotoxin.At present 'Shuang Hualian ' adopts traditional water extract-alcohol precipitation method effective component extracting, thus the formulation products of preparation form complicated, content is on the low side, causes that the preparation dose is big, difficult quality control, product quality and pharmacodynamic stability are not high.
Cyclodextrin effect research, clathrate preparation and each preparation about the SHUANGHUANLIAN compound recipe do not appear in the newspapers as yet to the lethal experimental study of antiendotoxin mice.
Summary of the invention
The invention belongs to a kind of novel extractive technique method of the modernization of Chinese medicine.System adopts beta-schardinger dextrin-and SHUANGHUANLIAN effective ingredient to form supermolecule (clathrate) through the molecular recognition process, thereby obtain stable multicomponent enclose compositions, reach the purpose of purification active ingredient of Chinese herbs, raising pharmaceutical ingredient content with simple technical process.Novel Chinese patent medicine with initiative good effect, quality controllable, easy, the taking convenience of preparation.
Cyclodextrin (particularly beta-schardinger dextrin-) and derivant thereof are fast-developing in recent years novel medicinal materials, at aspects such as improving pharmaceutical preparation performance, raising drug bioavailability great research and using value are arranged.Utilize the special performance of the molecular recognition of beta-schardinger dextrin-and medicine, the carrying out that we are successful the active component of single medicinal material Rhizoma Polygoni Cuspidati extract (CN), but the Chinese medicine compound extraction of active ingredients Separation Research that is applied to complicated component has not yet to see bibliographical information.
The present invention adopts cyclodextrin, and (for example β-CD) carries out mutual immixture with SHUANGHUANLIAN compound recipe medical material under specific condition, cyclodextrin and multiple composition are by molecular recognition mode supermolecular, the result of molecular recognition makes cyclodextrin only form stable supermolecule (clathrate) with wherein part composition, thereby SHUANGHUANLIAN effective ingredient extraction separation from the composition of numerous complexity is come out, the product of gained is the pharmaceutical composition that contains the various active composition, said composition has kept the activity of SHUANGHUANLIAN, the composition kind obtains simplifying, be the light yellow solid powder, quality is about the commonsense method extract of 1/4 amount.
The SHUANGHUANLIAN Chinese crude drug is mixed with a certain proportion of cyclodextrin respectively, or under given conditions,, obtain clathrate through separation, purification process with water, alcohol extract or water extract-alcohol precipitation extractum and the cyclodextrin mixed processing of medical material.This clathrate contains the compositions of the different chemical compound compositions of about kind more than 10, and content and form stablely has strong antiendotoxin, antibiotic, antiinflammatory and other activity.The clathrate that adopts this method to obtain can be directly used in the preparation Chinese medicine preparation, but also is used for other preparations behind the enclose (removal cyclodextrin).
Concrete scheme of the present invention is as follows.
The cyclodextrin supermolecular composition of Chinese medicine SHUANGHUANLIAN, its composition comprises Chinese medicine SHUANGHUANLIAN and cyclodextrin, and described Chinese medicine SHUANGHUANLIAN is medical material dry powder or its crude extract, and the mass ratio of Chinese medicine SHUANGHUANLIAN medical material dry powder and cyclodextrin is 1: 6~1: 3; The mass ratio of Chinese medicine SHUANGHUANLIAN crude extract and cyclodextrin is 1: 10~1: 3.
Described supermolecular composition is by the SHUANGHUANLIAN mixing active ingredients thing that do not contain cyclodextrin of clathrate through obtaining behind the remove enclose; The step of described " clathrate is through remove enclose " is:
The supermolecular of SHUANGHUANLIAN medical material: with the SHUANGHUANLIAN pulverizing medicinal materials, sieve medicated powder, standby;
Medicated powder refluxes with nontoxic or low toxicity organic solvent, filters, and steaming removes organic solvent and obtains crude extract;
The water of cyclodextrin with 1~30 times is mixed, make into suspended substance or solution, add the medical material powder of mass ratio 1/6~1/3 amount or the crude extract of 1/10~1/3 amount, mix, stir, filter, washing or extraction, steaming desolventize, are drying to obtain light solid enclose compositions.
The composition of the Chinese medicine SHUANGHUANLIAN in the above scheme and the ratio of each medical material wherein can adopt the prescription on the state-promulgated pharmacopoeia (version in 2000).Ratio wherein is Chinese medicine SHUANGHUANLIAN compositions to be done as a whole, makes comparisons with cyclodextrin.
Described cyclodextrin is beta-schardinger dextrin-or or derivatives thereof HP-or sulfobutyl ether-beta-schardinger dextrin-.The present invention recommends to adopt beta-schardinger dextrin-.
Said composition is with the aqueous solution of cyclodextrin or suspended substance, adds medical material powder or 1/10~1/3 crude extract of measuring that mass ratio 1/6~1/3 is measured, and through mixing, stirring, separation, drying obtain; Wherein said crude extract is that the medical material powder of Chinese medicine SHUANGHUANLIAN is carried the dark solid thing that ethanol precipitation obtains with common organic solvent extraction method or water.
Above compositions is an enclose state combination thing, can be used as raw material and makes peroral dosage forms such as tablet, capsule, also can enclose after (non-enclose state combination thing) prepare other preparations, when making various dosage form, add various adjuvants by the pharmaceutical preparation prior art.
Need to prove: described " mixture that do not conform to plurality of active ingredients that cyclodextrin arranged of clathrate " through obtaining behind the remove enclose, with the compositions of not carrying out before the cyclodextrin inclusion compound is different: cyclodextrin combines formation supermolecule (clathrate) with constituent specific in molecular recognition mode and the SHUANGHUANLIAN compound recipe medical material, easy and the non-enclose component separating of enclose composition, thereby reach the purpose of extracting active component, these are significantly different with solution distribution extraction principle method with traditional chromatographic technique.The present invention carries out enclose enclose more earlier to medicine, is the key operation of technology and be not unnecessary step.
The preparation method of the cyclodextrin supermolecular composition of described Chinese medicine SHUANGHUANLIAN, step is as follows:
The supermolecular of SHUANGHUANLIAN medical material: the ratio of will writing out a prescription SHUANGHUANLIAN pulverizing medicinal materials gets the medical material powder, and is standby; Perhaps,
The medicinal material coarse powder that pulverizing obtains adds the solvent refluxing of ethanol or ethyl acetate, butanols or these solvent, filters, and steams to desolventize to obtain crude extract, and is standby; Perhaps,
Medicinal material coarse powder that pulverizing obtains adds pure water and refluxes, and filters, and steams to dewater to the medicated porridge shape, adds ethanol, standing over night, filter solution, steam to desolventize and obtain crude extract, standby.
The water of cyclodextrin with 1~30 times is mixed, make into suspended substance or solution, add the medical material powder of mass ratio 1/6~1/3 amount or the crude extract of 1/10~1/3 amount, mix, stir, filter, precipitation, washing or extraction, steaming desolventize, are drying to obtain light yellow solid clathrate (enclose state combination thing).
When adopting non-enclose state combination thing, increase following steps:
With above-mentioned enclose state combination thing ethanol, heating remove enclose and obtain yellow solid compositions (non-enclose state combination thing).
Above preparation method more optimize and more specifically step be:
The supermolecular of SHUANGHUANLIAN medical material:
According to usual method with pulverizing medicinal materials, sieve the medical material powder, standby; Perhaps,
Medicated powder repeats 3 times according to common organic solvent extraction method with ethanol or ethyl acetate, butanols or mixed solvent: measure solvents for 10 times for the first time; Measure solvents for 8 times for the second time; Measure solvents for 5 times for the second time, merging filtrate, steaming removes organic solvent and obtains crude extract; Perhaps,
The medicinal material coarse powder that pulverizing obtains is extracted according to common water extract-alcohol precipitation method and obtained crude extract, and is standby.
Beta-schardinger dextrin-is mixed with 3~20 times of amount pure water, make into suspended substance or solution, add the medical material powder of mass ratio 1/6~1/3 amount or the crude extract of 1/10~1/3 amount, fully mix, stirred 5~24 hours, filter, precipitation, washing or extraction, steaming desolventize, are drying to obtain light yellow solid clathrate (enclose state combination thing).Further that clathrate and low amounts of water is moistening and reconcile into pasty state, progressively add 15 times of amount ethanol under the heating condition, heated and stirred refluxed 2 hours, cooling, filtered, the residual solids thing adds 10 times of amount ethanol extractions once again, merging filtrate steam desolventize solids.The solids that obtains with 10 times of amount ethanol heated and stirred, cools off, filters again, steams to desolventize promptly to get yellow solid compositions (non-enclose state combination thing).Per 100 gram SHUANGHUANLIAN medical materials can be handled and obtain the yellow non-enclose state combination thing of about 3.23~3.6 grams, and quality is about 25% amount of the crude extract of solvent method extraction.
Advantage of the present invention:
Drug component is simplified and stable content: the particular chemical composition in beta-schardinger dextrin-and the Chinese crude drug forms supermolecule (clathrate), and the chemical constituent quantity that enclose obtains is constant, and each composition relative amount is basicly stable.Make the definite ingredients, quality controllable of compositions of gained.Multi-wavelength HPLC finger printing check analysis shows, chemical constituent that the yellow solid compositions that processing obtains through enclose contains and crude extract comparable group are divided obviously minimizing, what reduce mainly is water-soluble component, and liposoluble constituent obtains keeping and enrichment (accompanying drawing 1; Accompanying drawing 2).The sample quality of many batches of preparations is stable, the chemical constituent favorable reproducibility.
Be easy to preparation processing: the composition product form of gained of the present invention has 2 kinds, and one is enclose state combination thing (clathrate), is light yellow solid, can directly prepare oral formulations; Another is non-enclose state combination thing (a non-enclose state combination thing), is yellow solid, can be used for preparing oral or non-oral formulation.
Supermolecular composition is active strong: in-vitro antibacterial test, the interior antiinflammatory of mice body are tested and antagonism mice endotoxin causes death, and result of the test shows, the compositions of gained of the present invention has identical pharmacologically active with commercially available SHUANGHUANGLIAN KOUFUYE, active close with crude drug dosage; But the activity of unit mass extract, supermolecular composition are about 1/4 of SHUANGHUANGLIAN KOUFUYE dosage, obviously are better than commercially available SHUANGHUANGLIAN KOUFUYE.In addition, contrast test proves, the supermolecular composition that is prepared respectively by each single medicinal material of prescription does not have activity or actively significantly reduces.The in-vitro antibacterial result of the test sees Table 1, and the supermolecular composition antibacterial activity is good.
Table 1 in-vitro antibacterial least concentration (unit: the mg crude drug/ml)
Figure C20051004090800091
Antiinflammatory evidence in the mice body of dosage 20g/kg (crude drug/body weight), composition sample and SHUANGHUANGLIAN KOUFUYE have close antiinflammatory action, see Table 2,
Antiinflammatory result of the test (n=10, P<0.05) in the mice body
Figure C20051004090800092
With compositions test specimen and SHUANGHUANGLIAN KOUFUYE 40g/kg (crude drug/body weight) dosage and the 12mg/kg dosage dexamethasone positive, the deadly result of the test of antagonism mice endotoxin sees Table 3, and the compositions activity is better than active SHUANGHUANGLIAN KOUFUYE.
The deadly result of the test of table 3 antagonism mice endotoxin
Figure C20051004090800093
Operation principle and work process:
Wherein clathrate, clathrate preparation are the keys of the technology of the present invention.
The enclose principle:
Beta-schardinger dextrin-is the outer heptatomic ring shape glucan structure that hydrophobic cavity is arranged in hydrophilic, hydrophobic molecule that spatial volume is less or hydrophobic group are easy to enter the beta-schardinger dextrin-hydrophobic cavity, except that space factor, the interactions such as intermolecular Van der Waals force, hydrophobic interaction, hydrogen bond and charge effect of micromolecule and beta-schardinger dextrin-are also depended in the formation of enclose, the existence of intermolecular " the suitable and interaction in space " is the fundamental of clathration, and multiple effect forms the process of stablizing clathrate down and is called molecular recognition again.Molecular recognition makes intermolecular assembling become the stable supermolecule of structural energy (clathrate).The specific molecular of Chinese medicine SHUANGHUANLIAN can form stable supermolecule (clathrate) with beta-schardinger dextrin-, clathrate with other not the enclose molecule have different physical characteristics, thereby, adopt the supermolecule technical method of molecular recognition the component of SHUANGHUANLIAN can be divided into enclose and non-enclose two big class components, thereby reach the purpose of purification SHUANGHUANLIAN effective ingredient.
By pharmacological testing, can carry out the screening active ingredients of component to enclose and non-enclose two big class components.Result of the test of the present invention, the clathrate that SHUANGHUANLIAN and beta-schardinger dextrin-form partly is the active part of SHUANGHUANLIAN, but not the enclose part does not have activity substantially.
The electron spectrum experiment shows, with the conditional formation constant>3000M of the bonded SHUANGHUANLIAN active component of beta-schardinger dextrin-clathrate -1, but not the conditional formation constant<300M of enclose part -1Bigger stability constant shows that the enclose part can form clathrate with beta-schardinger dextrin-, can not be under the usual conditions by solvolysis, and solid heating does not down dissociate yet.Thereby can with other enclose molecular separation not.
At present existing numerous bibliographical informations are about the research of SHUANGHUANLIAN active component, adopt CAChe 6.1.1 computer software, analog computation the representative compounds of SHUANGHUANLIAN active component and beta-schardinger dextrin-form the energy variation of clathrate, see Table 4, the enclose of SHUANGHUANLIAN active component and beta-schardinger dextrin-has bigger stabilization energy, shows that these active component can both form stable clathrate with beta-schardinger dextrin-.
Table 4 SHUANGHUANLIAN active component/beta-cyclodextrin inclusion compound energy
The inventive point of innovation and creation:
Beta-schardinger dextrin-and the effect of SHUANGHUANLIAN compound recipe medical material, beta-schardinger dextrin-combines with specific constituent in the molecular recognition mode and forms supermolecule (clathrate), easy and the non-enclose component separating of enclose composition, thereby reach the purpose of extracting active component, these are significantly different with solution distribution extraction principle method with traditional chromatographic technique.
The compositions of SHUANGHUANLIAN compound recipe medical material supermolecular gained is the Chinese medicine multicomponent mixture, and its composition is the comprehensive function result of each single medicinal material in the compound recipe.
Supermolecular composition is formed stable content, impurity is few, and outward appearance is good, and preparation method is simple, kept former side activity.
Description of drawings
Fig. 1 is HPLC finger printing contrast figure: 1. crude extract 2. enclose compositionss 3. SHUANGHUANGLIAN KOUFUYE 4. enclose component (chromatographic condition: chromatographic column (Lichrospher C not 18, 4.6mm * 250mm, 5 μ m); Mobile phase: methanol-water gradient (0~6min, 1~11%CH 3OH; 6~8min, 11~23%CH 3OH; 8~26min, 23~50%CH 3OH; 26~50min, 50~100%CH 3OH; Behind the 60min, 100%CH 3OH); Flow velocity: 1.0ml/min; Column temperature: 25 ℃; Detect wavelength: 280nm; Range: 0.05AUFS; Sample size 20 μ L);
Fig. 2 is HPLC finger printing contrast figure: 1. crude extract 2. enclose compositionss 3. oral liquid SHUANGHUANLIAN 4. enclose component (chromatographic condition: chromatographic column (Lichrospher C not 18, 4.6mm * 250mm, 5 μ m); Mobile phase: methanol-water gradient (0~6min, 1~11%CH 3OH; 6~8min, 11~23%CH 3OH; 8~26min, 23~50%CH 3OH; 26~50min, 50~100%CH 3OH; Behind the 60min, 100%CH 3OH); Flow velocity: 1.0ml/min; Column temperature: 25 ℃; Detect wavelength: 254nm; Range: 0.05AUFS; Sample size 20 μ L);
The specific embodiment
Embodiment 1, enclose: by usual method Chinese medicine SHUANGHUANLIAN medical material is cleaned dried and crushed and get medicated powder.Beta-schardinger dextrin-is mixed with 20 times of amount pure water, make into suspended substance or solution, add medical material powder with respect to beta-schardinger dextrin-mass ratio 1/3 amount, fully mix the back soaked overnight, heat under 60 ℃ of conditions and stirred 24 hours, heat filtering, filtrate cooling, medicinal residues add 60 ℃ of extractions of water heating once with beta-schardinger dextrin-again, filter merging filtrate, cooling, filter, the gained solids is washed under 2 times, 60 ℃ and is drying to obtain light solids (enclose compositions).
Remove enclose: clathrate and low amounts of water are reconciled into paste, progressively add 15 times of amount ethanol under heating 70 ℃, refluxed then 2 hours, cooling, filter, the residual solids thing adds 10 times of amount ethanol extractions once again, merging filtrate, steam desolventize solids.
Making with extra care of remove enclose thing: the remove enclose thing solid crude product that obtains is cooled off, is filtered with 60 ℃ of insulated and stirred of 10 times of amount ethanol, and filtrate steaming removal solvent promptly gets the yellow solid compositions of non-enclose attitude.
Embodiment 2, and Chinese medicine SHUANGHUANLIAN medical material powder makes dark extract (crude extract) with common ethanol extraction method.1 part of crude extract is mixed with 10 parts of beta-schardinger dextrin-s and 30 parts of pure water, stirred 8 hours under 60 ℃ of conditions, cooling is filtered, and solids washes with water and is drying to obtain light solids (enclose compositions) under 2 times, 60 ℃.
Light color enclose compositions is passed through remove enclose, is made the yellow solid compositions of non-enclose attitude.
Embodiment 3, Chinese medicine SHUANGHUANLIAN medical material powder with common decoction and alcohol sedimentation technique extract crude extract.1 part of crude extract is mixed with 10 parts of beta-schardinger dextrin-s and 30 parts of pure water, stirred 8 hours under 60 ℃ of conditions, cooling is filtered, and solids washes with water and is drying to obtain light solids (compositions) under 2 times, 60 ℃.
Light color enclose compositions is passed through remove enclose, is made the yellow solid compositions of non-enclose attitude.
Embodiment 4, and is substantially the same manner as Example 1, but following change is arranged: the addition of medical material powder is: be the amount of mass ratio 1/6 with respect to beta-schardinger dextrin-; Cyclodextrin is to mix with 3 parts of pure water; Add under 60 ℃ of conditions of material post-heating and stirred 8 hours.
Embodiment 5, and is substantially the same manner as Example 2, but following change is arranged: with 1 part of crude extract and 3 parts of beta-schardinger dextrin-s and 10 parts of mixed clathrates that get of pure water.
Embodiment 6, and is substantially the same manner as Example 2, but mixes reflux, extract, with medicated powder 2 times with butanols, and post processing obtains crude extract.
Embodiment 7, and is substantially the same manner as Example 2, but mixes reflux, extract, with medicated powder 2 times with ethyl acetate, and post processing obtains crude extract.
Embodiment 8, and is substantially the same manner as Example 2, but the medicated powder that refluxes adopts the mixed solvent of ethanol and butanols.
Embodiment 9, and is substantially the same manner as Example 2, but the medicated powder that refluxes adopts the mixed solvent of ethanol and ethyl acetate.
Embodiment 10, and is substantially the same manner as Example 3, but with 1 part of crude extract and 5 parts of beta-schardinger dextrin-s and 15 parts of mixed clathrates that get of pure water.
Embodiment 11, and is substantially the same manner as Example 2, makes clathrate in 24 hours but stir under 60 ℃ of conditions.
Embodiment 12, and is substantially the same manner as Example 3, makes clathrate in 24 hours but stir under 60 ℃ of conditions.
Embodiment 13,14, and is basic identical with embodiment 1 or 2, but following change is arranged: the cyclodextrin that is adopted is a HP-; Cyclodextrin is to mix with 1 part of pure water
Embodiment 15,16, and is basic identical with embodiment 1 or 2, but following change is arranged: the cyclodextrin that is adopted is sulfobutyl ether-beta-schardinger dextrin-.
Embodiment 16,17, and is basic identical with embodiment 1 or 2, but following change is arranged: made enclose state combination thing, directly make peroral dosage forms such as tablet, capsule as raw material, and remove the enclose step.

Claims (6)

1, a kind of cyclodextrin supermolecular composition of Chinese medicine SHUANGHUANLIAN, its raw material is formed and is comprised Chinese medicine SHUANGHUANLIAN and cyclodextrin, described Chinese medicine SHUANGHUANLIAN is the crude extract of Chinese medicine SHUANGHUANLIAN medical material, and the mass ratio of Chinese medicine SHUANGHUANLIAN crude extract and cyclodextrin is 1: 101: 3;
Described supermolecular composition is by the SHUANGHUANLIAN mixing active ingredients thing that do not contain cyclodextrin of clathrate through obtaining behind the remove enclose; The step of described " clathrate is through remove enclose " is:
The supermolecular of SHUANGHUANLIAN medical material: with the SHUANGHUANLIAN pulverizing medicinal materials, sieve medicated powder, standby;
Medicated powder refluxes with nontoxic or low toxicity organic solvent, filters, and steaming removes organic solvent and obtains crude extract;
The water of cyclodextrin with 1~30 times is mixed, make into suspended substance or solution, add the medical material powder of mass ratio 1/6~1/3 amount or the crude extract of 1/10~1/3 amount, mix, stir, filter, washing or extraction, steaming desolventize, are drying to obtain light solid enclose compositions.
2, according to the cyclodextrin supermolecular composition of the described Chinese medicine SHUANGHUANLIAN of claim 1, it is characterized in that: described cyclodextrin is beta-schardinger dextrin-or derivatives thereof HP-or sulfobutyl ether-beta-schardinger dextrin-.
3, the preparation method of the cyclodextrin supermolecular composition of the described Chinese medicine SHUANGHUANLIAN of a kind of claim 1, step is as follows: the supermolecular of SHUANGHUANLIAN medical material: with the SHUANGHUANLIAN pulverizing medicinal materials, sieve medicated powder, standby;
Medicated powder refluxes with nontoxic or low toxicity organic solvent, filters, and steaming removes organic solvent and obtains crude extract;
The water of cyclodextrin with 1~30 times is mixed, make into suspended substance or solution, add the medical material powder of mass ratio 1/6~1/3 amount or the crude extract of 1/10~1/3 amount, mix, stir, filter, washing or extraction, steaming desolventize, are drying to obtain light solid enclose compositions.
4, according to the preparation method of the cyclodextrin supermolecular composition of the described Chinese medicine SHUANGHUANLIAN of claim 3, it is characterized in that the concrete operations of described each step are:
The supermolecular of SHUANGHUANLIAN medical material:
According to usual method with pulverizing medicinal materials, sieve medicated powder, standby; Perhaps,
Medicated powder is nontoxic or low toxicity organic solvent backflow with ethanol, ethyl acetate, butanols etc., filters, and steaming removes organic solvent and obtains crude extract; Perhaps,
Medicated powder refluxes with pure water, filters, and steams to dewater to the medicated porridge shape, adds ethanol, standing over night, filter solution, steam to desolventize and obtain crude extract, standby.
Beta-schardinger dextrin-is mixed with 3~20 times of amount pure water, make into suspended substance or solution, add the medical material powder of mass ratio 1/6~1/3 amount or the crude extract of 1/10~1/3 amount, fully mix, stirred 8~24 hours, filter, washing or extraction, steaming desolventize, are drying to obtain light solid composite.
According to the preparation method of the cyclodextrin supermolecular composition of the described Chinese medicine SHUANGHUANLIAN of claim 4, it is characterized in that 5, also increasing has following steps:
Described enclose state combination thing and low amounts of water are reconciled into pasty state, progressively add ethanol under the heating condition, reflux 2 hours, cooling, filtration, the residual solids thing adds 10 times of amount ethanol extractions once again, merging filtrate steam desolventize solids, the solids that obtains is again with 10 times of amount ethanol heated and stirred, cooling, filtration, steaming desolventizes and promptly gets the non-enclose compositions of yellow solid.
6, according to the preparation method of the cyclodextrin supermolecular composition of claim 3 or 4 or 5 described Chinese medicine SHUANGHUANLIAN, it is characterized in that,
Described nontoxic or low toxicity organic solvent is ethanol, ethyl acetate, butanols, or two or more mixture wherein.
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双黄连粉针剂研究. 杨静,姚春惠,黄熙春.黑龙江医药,第11卷第2期. 1998
双黄连粉针剂研究. 杨静,姚春惠,黄熙春.黑龙江医药,第11卷第2期. 1998 *

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