阅读说明：本技术 一种银杏叶组合物和制备方法 (A kind of compositions extracted from gingko biloba leaves and preparation method ) 是由 徐仁华 于 2019-09-09 设计创作，主要内容包括：本发明提供的一种银杏叶组合物和制备方法,包括如下原料：银杏叶提取物、微晶纤维素、乳糖、预胶化淀粉、交联羧甲基纤维素钠、二氧化硅和乙醇溶液,通过选择银杏叶提取物与上述辅料组合配合协同,使得制备的银杏叶组合物进入人体内后不同性质的成分可以溶解于同一反应体系内,增强各成分之间的协同作用,提高药效,同时上述银杏叶组合物还具有较理想的颗粒流动性、硬度、脆碎度和崩解时限,具有一定的稳定性。(A kind of compositions extracted from gingko biloba leaves provided by the invention and preparation method, including the following raw material: ginkgo biloba p.e, microcrystalline cellulose, lactose, pregelatinized starch, croscarmellose sodium, silica and ethanol solution, it is cooperateed with by selection ginkgo biloba p.e with the cooperation of above-mentioned auxiliary material combination, ingredient of different nature is dissolved in same reaction system after the compositions extracted from gingko biloba leaves of preparation is entered in human body, enhance the synergistic effect between each ingredient, improve drug effect, above-mentioned compositions extracted from gingko biloba leaves also has comparatively ideal mobility of particle simultaneously, hardness, friability and disintegration time limited, with certain stability.)

1. a kind of compositions extracted from gingko biloba leaves, which is characterized in that the raw material including following parts by weight: 40 parts of ginkgo biloba p.e, crystallite 70-90 parts of cellulose, 30-50 parts of lactose, 5-25 parts of pregelatinized starch, 2-6 parts of croscarmellose sodium, silica 0.5-1.5 parts and 15-25 parts of 95% ethanol solution of volumetric concentration.

2. compositions extracted from gingko biloba leaves according to claim 1, which is characterized in that the raw material including following parts by weight: ginkgo leaf 40 parts of extract, 80 parts of microcrystalline cellulose, 40 parts of lactose, 15 parts of pregelatinized starch, 4 parts of croscarmellose sodium, dioxy 20 parts of 1 part of SiClx and 95% ethanol solution of volumetric concentration.

3. compositions extracted from gingko biloba leaves according to claim 1 or 2, which is characterized in that the ginkgo biloba p.e is nanoscale Ginkgo biloba p.e, particle size range 100-300nm.

4. compositions extracted from gingko biloba leaves according to claim 1-3, which is characterized in that further include oily phase, 5-15 weight Part；The oil mutually includes at least one of ethyl linoleate, ethyl oleate, oleic acid, soybean oil, castor oil and olive oil.

5. compositions extracted from gingko biloba leaves according to claim 1-4, which is characterized in that further include the first auxiliary agent, 1-5 weight Measure part；First auxiliary agent includes at least one of polyethylene glycol and glycerol.

6. compositions extracted from gingko biloba leaves according to claim 1-5, which is characterized in that further include the second auxiliary agent, 5-25 Parts by weight；Second auxiliary agent includes at least one of phosphatide and lecithin.

7. a kind of method for preparing compositions extracted from gingko biloba leaves described in any one of claims 1-6, which is characterized in that including walking as follows It is rapid: to take ginkgo biloba p.e, microcrystalline cellulose, lactose and the pregelatinized starch of recipe quantity, sieving mixes, and adds the ethyl alcohol of recipe quantity Solution, stirring, sieving granulation is dry, and whole grain of being sieved is added the croscarmellose sodium and silica of recipe quantity, mixes It is even, clinically acceptable dosage form is made.

8. the preparation method of compositions extracted from gingko biloba leaves according to claim 7, which comprises the steps of: take place At least one of the ginkgo biloba p.e just measured and oily phase, the first auxiliary agent and second auxiliary agent mix, then addition recipe quantity Microcrystalline cellulose, lactose and pregelatinized starch, sieving mix, and add the ethanol solution of recipe quantity, stir, sieving granulation, dry, mistake Whole grain is sieved, the croscarmellose sodium and silica of recipe quantity is added, mixes, clinically acceptable dosage form is made.

9. the preparation method of compositions extracted from gingko biloba leaves according to claim 7 or 8, which is characterized in that further include that ginkgo leaf mentions The preparation method for taking object is included the following steps: that ginkgo leaf is taken to crush, is taken with the extraction of ethanol solution temperature, recycle ethyl alcohol, be concentrated, so After add water and stir, refrigerate, filtering, by the upper large pore resin absorption column of gained filtrate, respectively with water, volumetric concentration for 10-20% second Alcoholic solution, volumetric concentration are the elution of 65-75% ethanol solution, and collected volume concentration is the eluent of 65-75% ethyl alcohol, are depressurized dense Contracting.

10. the preparation method of compositions extracted from gingko biloba leaves according to claim 9, which is characterized in that the ginkgo biloba p.e Preparation method, include the following steps: that ginkgo leaf is taken to crush, with the volumetric concentration 65-75% ethanol solution temperature leaching of 3-9 times of weight It extracts at least 1 time, each 1-3h, recycles ethyl alcohol, concentration, then plus the water of 3-6 times of weight stirs, 2-6 DEG C of refrigeration 8-16h, mistake Filter, by the upper large pore resin absorption column of gained filtrate, respectively be 10-20% ethanol solution with water, volumetric concentration, volumetric concentration is The elution of 65-75% ethanol solution, collected volume concentration are the eluent of 65-75% ethyl alcohol, are concentrated under reduced pressure.

Technical field

The invention belongs to field of pharmaceutical preparations, and in particular to a kind of compositions extracted from gingko biloba leaves and preparation method.

Background technique

Ginkgo leaf is the dried leaf of Ginkgoaceae plant Ginkgo biloba Ginkgo bilobaL., and the still green Shi Caishou of autumn leaf is dry in time It is dry.Ginkgo biloba p.e and preparation are widely used in clinic, have expansion cardiovascular and cerebrovascular, improve microcirculation, antiplatelet activation The pharmacological actions such as the factor, anti-oxidant, antiviral and antibacterial anti-inflammatory.Clinically it is mainly used for senile dementia, hyperlipemia, coronary disease Disease, chronic bronchitis, post-traumatic brain syndrome, cerebral embolism, cerebral angiospasm, shaking plasy and lower limbs arteritis etc..

Main active substances are Ginkgolides and ginkgolides in ginkgo biloba p.e.It has proven convenient that Ginkgolides have There is the effects of expansion coronary vasodilator, improve blood vessel distal and Cerebrovascular disorders, reduce cholesterol, is anti-oxidant；Ginkgolides is blood The strong antagonist of platelet activation factor-PAF has protective effect to myocardial ischemia, cerebral hypoxia ischemia.According to modern pharmacological research table Bright, the pharmacological action of ginkgo biloba p.e is to cooperate with to play drug effect by each component therein, however, in Long-term clinical medication In, it has been found that due to the complicated component in ginkgo biloba p.e, each compositional polarity is different, has water-soluble, has fat-soluble , it is not easily dissolved in same system inner part ingredient or solubility is low, the synergistic effect played between each ingredient is limited, influences Drug effect.

Summary of the invention

Therefore, the technical problem to be solved in the present invention is that overcoming ginkgo biloba p.e complicated component in the prior art, Synergistic effect between ingredient each in same system is limited, influences drug effect, and then provides a kind of compositions extracted from gingko biloba leaves and preparation Method, the compositions extracted from gingko biloba leaves are cooperateed with by the cooperation of each raw material, so that most of opposed polarity in ginkgo biloba p.e Ingredient is dissolved in same system, enhances the synergistic effect between each ingredient, improves drug effect.

For this purpose, the present invention provides the following technical scheme that

A kind of compositions extracted from gingko biloba leaves, the raw material including following parts by weight: 40 parts of ginkgo biloba p.e, microcrystalline cellulose 70- 90 parts, 30-50 parts of lactose, 5-25 parts of pregelatinized starch, 2-6 parts of croscarmellose sodium, 0.5-1.5 parts of silica and 15-25 parts of 95% ethanol solution of volumetric concentration.

In the compositions extracted from gingko biloba leaves, the raw material including following parts by weight: 40 parts of ginkgo biloba p.e, crystallite are fine 80 parts of dimension element, 40 parts of lactose, 15 parts of pregelatinized starch, 4 parts of croscarmellose sodium, silica 1 part and volumetric concentration 95% 20 parts of ethanol solution.

In the compositions extracted from gingko biloba leaves, the ginkgo biloba p.e is nano ginkgo leaf extract, particle size range For 100-300nm.

It further include oily phase, 5-15 parts by weight in the compositions extracted from gingko biloba leaves；It is described oil mutually include ethyl linoleate, At least one of ethyl oleate, oleic acid, soybean oil, castor oil and olive oil.

It further include the first auxiliary agent, 1-5 parts by weight in the compositions extracted from gingko biloba leaves；First auxiliary agent includes poly- second At least one of two pure and mild glycerol.

It further include the second auxiliary agent, 5-25 parts by weight in the compositions extracted from gingko biloba leaves；Second auxiliary agent includes phosphatide At least one of with lecithin.

The present invention provides a kind of methods for preparing the compositions extracted from gingko biloba leaves, include the following steps: to take recipe quantity Ginkgo biloba p.e, microcrystalline cellulose, lactose and pregelatinized starch, sieving mix, and add the ethanol solution of recipe quantity, stir, mistake Sieve granulation, dry, whole grain of being sieved is added the croscarmellose sodium and silica of recipe quantity, mixes, be made clinically Acceptable dosage form.

In the preparation method of the compositions extracted from gingko biloba leaves, include the following steps: the ginkgo biloba p.e for taking recipe quantity It is mixed at least one of oily phase, the first auxiliary agent and the second auxiliary agent, the microcrystalline cellulose of recipe quantity, lactose and pre- is then added Gelling starch, sieving mix, and add the ethanol solution of recipe quantity, stir, sieving granulation, dry, and recipe quantity is added in whole grain of being sieved Croscarmellose sodium and silica mix, clinically acceptable dosage form are made.

It further include the preparation method of ginkgo biloba p.e, including such as in the preparation method of the compositions extracted from gingko biloba leaves Lower step: taking ginkgo leaf to crush, and is taken with the extraction of ethanol solution temperature, recycles ethyl alcohol, then concentration adds water and stirs, and refrigerates, filtering, It is respectively 10-20% ethanol solution, volumetric concentration 65- with water, volumetric concentration by the upper large pore resin absorption column of gained filtrate The elution of 75% ethanol solution, collected volume concentration are the eluent of 65-75% ethyl alcohol, are concentrated under reduced pressure.

In the preparation method of the compositions extracted from gingko biloba leaves, the preparation method of the ginkgo biloba p.e, including it is as follows Step: taking ginkgo leaf to crush, and takes at least 1 time with the volumetric concentration 65-75% ethanol solution temperature extraction of 3-9 times of weight, each 1- 3h recycles ethyl alcohol, and concentration, then plus the stirring of the water of 3-6 times of weight, 2-6 DEG C of refrigeration 8-16h are filtered, by the upper macropore of gained filtrate Adsorption resin column is respectively 10-20% ethanol solution with water, volumetric concentration, volumetric concentration is the elution of 65-75% ethanol solution, Collected volume concentration is the eluent of 65-75% ethyl alcohol, is concentrated under reduced pressure.

Technical solution of the present invention has the advantages that

1. a kind of compositions extracted from gingko biloba leaves provided by the invention, including the following raw material: ginkgo biloba p.e, microcrystalline cellulose, Lactose, pregelatinized starch, croscarmellose sodium, silica and ethanol solution, by selection ginkgo biloba p.e with Above-mentioned auxiliary material combination cooperation collaboration, ingredient of different nature dissolves after the compositions extracted from gingko biloba leaves of preparation is entered in human body In in same reaction system, enhancing the synergistic effect between each ingredient, drug effect is improved, while above-mentioned compositions extracted from gingko biloba leaves also has Comparatively ideal mobility of particle, hardness, friability and disintegration time limited have certain stability.

2. a kind of compositions extracted from gingko biloba leaves provided by the invention, the ginkgo biloba p.e is nano ginkgo leaf extract, Particle size range is 100-300nm, and after ginkgo biloba p.e is crushed to nanoscale, the surface area per unit volume product of particle is sharply increased, together When with the other components coordinated in composition, substantially increase in ginkgo biloba p.e hydrophilic ingredient and lipophilic Ingredient dissolution, improves bioavilability.

3. a kind of compositions extracted from gingko biloba leaves provided by the invention further includes oily phase, 5-15 parts by weight；The oil mutually includes sub- oil At least one of acetoacetic ester, ethyl oleate, oleic acid, soybean oil, castor oil and olive oil pass through above-mentioned oily phase, the first auxiliary agent, the Other raw material coordinateds in the combination of two auxiliary agents and compositions extracted from gingko biloba leaves, greatly improve of different nature in ginkgo biloba p.e The solubility of ingredient, further increases drug effect.

4. a kind of compositions extracted from gingko biloba leaves provided by the invention further includes the first auxiliary agent, 1-5 parts by weight；First auxiliary agent Including at least one of polyethylene glycol and glycerol, pass through the first above-mentioned auxiliary agent, the second auxiliary agent, the combination of oily phase and ginkgo leaf Other raw material coordinateds in composition greatly improve the solubility of ingredient of different nature in ginkgo biloba p.e, further Improve drug effect.

5. a kind of compositions extracted from gingko biloba leaves provided by the invention further includes the second auxiliary agent, 5-25 parts by weight；Second auxiliary agent Including at least one of phosphatide and lecithin, pass through the second above-mentioned auxiliary agent, the second auxiliary agent, the combination of oily phase and ginkgo leaf Other raw material coordinateds in composition greatly improve the solubility of ingredient of different nature in ginkgo biloba p.e, further Improve drug effect.

Specific embodiment

Raw material involved in following embodiments, reagent can be commercially available by commercially available.