CN105168141A - Preparation method and application of leaf type traditional Chinese medicinal material granules - Google Patents

Preparation method and application of leaf type traditional Chinese medicinal material granules Download PDF

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CN105168141A
CN105168141A CN201510635626.4A CN201510635626A CN105168141A CN 105168141 A CN105168141 A CN 105168141A CN 201510635626 A CN201510635626 A CN 201510635626A CN 105168141 A CN105168141 A CN 105168141A
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crude drug
chinese crude
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马新攀
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Henan Hang Zhi Patent Services Co Ltd
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Henan Hang Zhi Patent Services Co Ltd
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Abstract

The invention belongs to the technical field of preparation of traditional Chinese medicines and particularly relates to a preparation method and an application of leaf type traditional Chinese medicinal material granules. According to the preparation method, leaf type traditional Chinese medicinal materials are subjected to enzymolysis and ultrasonic wave-assisted treatment after being crushed, then microfiltration treatment is performed by the aid of a ceramic membrane, and the leaf type traditional Chinese medicinal material granules are obtained through concentration, drying, nano-crushing, sterilization and packaging finally. The preparation can be used for preparing traditional Chinese medicine compound preparations containing the leaf type traditional Chinese medicinal materials or leaf type traditional Chinese medicinal material extracts. With the adoption of the preparation method and the application, problems that the raw material utilization rate is low, active ingredients are not extracted completely, the extraction efficiency is low and the like when the traditional Chinese medicinal materials are extracted with a conventional method are solved, the whole process flow is simple to control and environment-friendly, all process steps have a synergistic effect, so that the extraction efficiency of the preparation method is higher, active ingredients are effectively protected, and the utilization rate of the leaf type traditional Chinese medicinal materials is increased.

Description

A kind of leaf class Chinese crude drug exempts from preparation method and the application thereof of decoct
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to preparation method and application thereof that a kind of leaf class Chinese crude drug exempts from decoct.
Background technology
Chinese medicine is the distinctive medicine of the Chinese tradition traditional Chinese medical science, with a long history, aboundresources.Chinese medicine ingredients complexity is various, if the process operation parameter not selecting suitable extraction, concentrated, preparation process and science strict in Chinese medicine preparation pharmacy procedure, extracts active ingredients can be caused not exclusively even to destroy effective ingredient, thus affect drug effect.The traditional dosage form of Chinese medicine has pill, powder, unguentum, medicated wine etc., but the deficiencies such as conventional dosage forms majority exists, and taking dose is large, dosage form thick, appearance poor, along with the raising of social development and people's economic level, these deficiencies have seriously constrained the paces of Chinese medicine development.Therefore, inheriting and developing on the basis of China's Advantages of TCM and characteristic, by modern high technology means, the extraction process of reform traditional, works out safety, modern Chinese medicine preparation is imperative efficiently.
The medical material that leaf class Chinese crude drug is is main medicinal part with the twig tip etc. of the vanelets of single leaf, compound leaf or band tender leaf.Leaf class Chinese medicine is indispensable important component part in Chinese material medicine resource, and leaf apoplexy due to endogenous wind crude drug source enriches, and pluck almost does not affect plant in good time.Along with the reinforcement of health of people consciousness, application natural plant material for treating disease, health care become trend.
The preparation of Chinese medicine compound preparation generally adopts the methods such as decocting method, circumfluence method, percolation to extract, but this several extracting method temperature in leaching process raises and easily causes thermal sensitivity effective ingredient to change, and extract yield is low, extraction time is long, technique is loaded down with trivial details.Due to leaf class Chinese crude drug complex chemical composition, traditional extraction process can destroy the effective ingredient in medical material.
Summary of the invention
Technical problem to be solved by this invention is, for the deficiencies in the prior art, provides the leaf class Chinese crude drug of a kind of efficacy stability, effectively extraction and protection effective ingredient to exempt from preparation method and the application thereof of decoct.
For solving the problems of the technologies described above, the technical solution adopted in the present invention is: a kind of leaf class Chinese crude drug exempts from the preparation method of decoct, comprises the following steps:
1) leaf class Chinese crude drug is picked up clean roguing, dry;
2) dried traditional Chinese medicine powder is broken into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 5 ~ 10 times amount in the Chinese crude drug fine powder that obtains, under 40 ~ 55 DEG C of conditions, soak 30 ~ 90min, the cellulase then adding Chinese crude drug fine powder weight 0.3% ~ 1.2% carries out enzymolysis, Sonication assisted treatment, obtains extracting solution;
4) extracting solution step 3) obtained carries out microfiltration process, then enters concentrator and concentrates, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains nanoscale Chinese medicine microgranule, sterilizing, packs and obtain free decoction agent.
Preferably, in described step 3), enzymatic hydrolysis condition is: enzyme activity 1 × 10 4u/g, hydrolysis temperature 40 ~ 55 DEG C, pH is 4.0 ~ 5.5, enzymolysis time 60 ~ 120min.
Preferably, in described step 3), supersonic treatment condition is: supersonic frequency 15 ~ 25kHz, power 300 ~ 500W, time 10 ~ 20min, and number of repetition is 2 ~ 3 times.
Preferably, in described step 4), microfiltration is Al 2o 3microfiltration of ceramic membrane process, Al 2o 3ceramic membrane aperture is 0.3 ~ 0.8 μm, and operation pressure reduction is 0.05 ~ 0.12MPa.
Preferably, concentrated in described step 4) is that filtrate is carried out vacuum concentration 50 ~ 60 DEG C time, and vacuum is 0.085 ~ 0.095MPa, is concentrated into 10% ~ 13% of former filtrate volume.
Preferably, in described step 5), the particle diameter of nanoscale Chinese medicine microgranule is 60 ~ 80nm.
Preferably, in described step 5), sterilizing methods is ultraviolet disinfection, autoclaving or ozone sterilization.
Present invention also offers above-mentioned preparation method gained and exempt from the application of decoct in preparation compound Chinese medicinal preparation, leaf class Chinese crude drug is exempted from decoct directly add in compound Chinese medicinal preparation, make pharmaceutically useful dosage form, described dosage form comprises decoction, granule, tablet, capsule, injection, powder, unguentum and pill.
Compared with prior art, the invention has the beneficial effects as follows:
1, the present invention adopts enzymatic isolation method to extract leaf class active ingredients from traditional Chinese medicinal, and adopts Sonication assisted treatment, can destroy plant cell wall, make the composition in plant cell more easily dissolve, spread by enzymolysis; The mode extracted in conjunction with ultrasonic assistant can increase molecular motion of material frequency and speed, increases solvent penetration power, improves drug-eluting speed and stripping number of times, shortens extraction time.
2, the present invention adopts microfiltration of ceramic membrane technology, and compared with conventional filtering method, microfiltration process is undergoing phase transition not, and operating condition is gentle, and be conducive to the physiologically active keeping Chinese medicine, medicinal liquid is refined, and improves concentrated and drying efficiency, improves the quality exempting from decoct.
3, the present invention adopts nano-pulverization technology, and the nano traditional Chinese medicine made exempts from the therapeutic effect that decoct can improve Chinese medicine, improves bioavailability, increases the stability of medicine, reduces dosage, reduces the toxic and side effects of Chinese medicine.
4, the present invention extracted in conjunction with ultrasonic assistant by zymolysis technique, the combination of microfiltration of ceramic membrane technology and nano-pulverization technology, solve conventional method and carry out the problems such as raw material availability low and extracts active ingredients efficiency when Chinese crude drug extracts is not high, be prepared into exempt from decoct use more convenient, more adapt to the allegro life of modern people.Whole process control of the present invention is simple, environmental protection, each processing step Synergistic; make preparation method universality of the present invention stronger; extraction efficiency is higher, and the effective ingredient of leaf class Chinese crude drug obtains and effectively extracts and protection, improves the availability of leaf class Chinese crude drug.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is further elaborated.
Leaf class Chinese crude drug exempts from a preparation method for decoct, comprises the following steps:
1) leaf class Chinese crude drug is picked up clean roguing, dry;
2) dried traditional Chinese medicine powder is broken into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 5 ~ 10 times amount in the Chinese crude drug fine powder that obtains, under 40 ~ 55 DEG C of conditions, soak 30 ~ 90min, the cellulase then adding Chinese crude drug fine powder weight 0.3% ~ 1.2% carries out enzymolysis, Sonication assisted treatment, obtains extracting solution;
4) extracting solution step 3) obtained carries out microfiltration process, then enters concentrator and concentrates, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains nanoscale Chinese medicine microgranule, sterilizing, packs and obtain free decoction agent.
In step 1), described drying can adopt low-temperature vacuum drying, measures the water content of leaf class Chinese crude drug below 3.0% after drying with moisture test apparatus.
In step 2) in, described pulverizing can adopt Chinese medicine grinder to pulverize, and after pulverizing, Chinese crude drug is more conducive to subsequent treatment.
In step 3), described enzymatic hydrolysis condition is preferably: enzyme activity 1 × 10 4u/g, hydrolysis temperature 40 ~ 55 DEG C, pH is 4.0 ~ 5.5, enzymolysis time 60 ~ 120min, enzyme has the specificity of height, destroys plant cell wall, make the composition in plant cell more easily dissolve, spread by suitable enzyme selectivity, mild condition, the easily removal of impurity, energy efficient, leaching rate are high, device simple, and can reduce heat-sensitive ingredients and change.Described supersonic treatment condition is preferably: supersonic frequency 15 ~ 25kHz, power 300 ~ 500W, time 10 ~ 20min, number of repetition is 2 ~ 3 times, the mode extracted in conjunction with ultrasonic assistant can increase molecular motion of material frequency and speed, increase solvent penetration power, improve drug-eluting speed and stripping number of times, shorten extraction time.
In step 4), described microfiltration is Al 2o 3microfiltration of ceramic membrane process, Al 2o 3ceramic membrane aperture is 0.3 ~ 0.8 μm, operation pressure reduction is 0.05 ~ 0.12MPa, and microfiltration of ceramic membrane technology is compared with conventional filtering method, and microfiltration process is undergoing phase transition not, operating condition is gentle, be conducive to the physiologically active keeping Chinese medicine, through microfiltration process, the high material of the relative molecular mass mainly non-medicinal ingredient such as colloid and cellulose can be removed, extracting solution is clarified, medicinal liquid is refined, and improves concentrated and drying efficiency, improves the quality exempting from decoct.Described concentrated be that filtrate is carried out vacuum concentration 50 ~ 60 DEG C time, vacuum is 0.085 ~ 0.095MPa, is concentrated into 10% ~ 13% of former filtrate volume, and cryogenic vacuum is concentrated can reduce solvent boiling point, temperature is low, speed is fast, saves the effective ingredient of Chinese medicine extraction liquid better.
In step 5), the particle diameter of described nanoscale Chinese medicine microgranule is 60 ~ 80nm, adopts nano-pulverization technology, the nano traditional Chinese medicine made exempts from the therapeutic effect that decoct can improve Chinese medicine, improves bioavailability, increases the stability of medicine, reduce dosage, reduce the toxic and side effects of Chinese medicine.Described sterilizing methods is ultraviolet disinfection, autoclaving or ozone sterilization; compared with conventional high-temperature sterilizing; ultraviolet disinfection, autoclaving or ozone sterilization can exempt from the effective ingredient of non-refractory high pressure in decoct by available protecting, improve drug bioavailability.
Present invention also offers above-mentioned preparation method gained and exempt from the application of decoct in preparation compound Chinese medicinal preparation, leaf class Chinese crude drug is exempted from decoct directly add in compound Chinese medicinal preparation, make pharmaceutically useful dosage form, described dosage form comprises decoction, granule, tablet, capsule, injection, powder, unguentum, pill.
Below by specific embodiment, those skilled in the art can be implemented.
Embodiment 1
For Folium Mori, it exempts from the preparation method of decoct, comprises the following steps:
1) Folium Mori are picked up clean roguing, dry;
2) dried powder of Folium Mori is broken into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 5 times amount in the Folium Mori fine powder that obtains, under 40 DEG C of conditions, soak 30min, then adding Chinese crude drug fine powder weight 0.3% enzyme activity is 1 × 10 4the cellulase of U/g is 40 DEG C in temperature, and pH is enzymolysis processing 60min under the condition of 4.0, simultaneously Sonication assisted treatment, and supersonic frequency 15kHz, power 300W, each 10min, repeat 2 times, obtain extracting solution;
4) extracting solution aperture step 3) obtained is the Al of 0.3 μm 2o 3ceramic membrane carries out microfiltration process, and operation pressure reduction is 0.05MPa, and then filtrate is carried out vacuum concentration 50 DEG C time, vacuum is 0.085MPa, is concentrated into 10% of former filtrate volume, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains the nanoscale Chinese medicine microgranule that particle diameter is 60 ~ 80nm, ultraviolet disinfection, packs and obtain free decoction agent.
Embodiment 2
For Folium Sennae, it exempts from the preparation method of decoct, comprises the following steps:
1) Folium Sennae is picked up clean roguing, dry;
2) dried Garfields Tea is broken into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 6 times amount in the Folium Sennae fine powder that obtains, under 45 DEG C of conditions, soak 50min, then adding Chinese crude drug fine powder weight 0.5% enzyme activity is 1 × 10 4the cellulase of U/g is 45 DEG C in temperature, and pH is enzymolysis processing 80min under the condition of 4.2, simultaneously Sonication assisted treatment, and supersonic frequency 18kHz, power 350W, each 12min, repeat 3 times, obtain extracting solution;
4) extracting solution aperture step 3) obtained is the Al of 0.5 μm 2o 3ceramic membrane carries out microfiltration process, and operation pressure reduction is 0.07MPa, and then filtrate is carried out vacuum concentration 53 DEG C time, vacuum is 0.090MPa, is concentrated into 11% of former filtrate volume, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains the nanoscale Chinese medicine microgranule that particle diameter is 60 ~ 80nm, autoclaving, packs and obtain free decoction agent.
Embodiment 3
For Folium Eriobotryae, it exempts from the preparation method of decoct, comprises the following steps:
1) Folium Eriobotryae is picked up clean roguing, dry;
2) dried Folium Eriobotryae powder is broken into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 8 times amount in the Folium Eriobotryae fine powder that obtains, under 50 DEG C of conditions, soak 60min, then adding Chinese crude drug fine powder weight 0.6% enzyme activity is 1 × 10 4the cellulase of U/g is 50 DEG C in temperature, and pH is enzymolysis processing 90min under the condition of 4.5, simultaneously Sonication assisted treatment, and supersonic frequency 20kHz, power 400W, each 15min, repeat 3 times, obtain extracting solution;
4) extracting solution aperture step 3) obtained is the Al of 0.6 μm 2o 3ceramic membrane carries out microfiltration process, and operation pressure reduction is 0.09MPa, and then filtrate is carried out vacuum concentration 55 DEG C time, vacuum is 0.095MPa, is concentrated into 12% of former filtrate volume, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains the nanoscale Chinese medicine microgranule that particle diameter is 60 ~ 80nm, ozone sterilization, packs and obtain free decoction agent.
Embodiment 4
For Folium Perillae, it exempts from the preparation method of decoct, comprises the following steps:
1) Folium Perillae is picked up clean roguing, dry;
2) dried Folium Perillae is ground into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 8 times amount in the Folium Perillae fine powder that obtains, under 52 DEG C of conditions, soak 80min, then adding Chinese crude drug fine powder weight 1.0% enzyme activity is 1 × 10 4the cellulase of U/g is 52 DEG C in temperature, and pH is enzymolysis processing 100min under 5.0 conditions, simultaneously Sonication assisted treatment, and supersonic frequency 22kHz, power 450W, each 18min, repeat 2 times, obtain extracting solution;
4) extracting solution aperture step 3) obtained is the Al of 0.6 μm 2o 3ceramic membrane carries out microfiltration process, and operation pressure reduction is 0.10MPa, and then filtrate is carried out vacuum concentration 58 DEG C time, vacuum is 0.085MPa, is concentrated into 13% of former filtrate volume, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains the nanoscale Chinese medicine microgranule that particle diameter is 60 ~ 80nm, autoclaving, packs and obtain free decoction agent.
Embodiment 5
For Folium Crataegi, it exempts from the preparation method of decoct, comprises the following steps:
1) Folium Crataegi is picked up clean roguing, dry;
2) dried Folium Crataegi is ground into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 10 times amount in the Folium Crataegi fine powder that obtains, under 55 DEG C of conditions, soak 90min, then adding Chinese crude drug fine powder weight 1.2% enzyme activity is 1 × 10 4the cellulase of U/g is 55 DEG C in temperature, and pH is enzymolysis processing 120min under the condition of 5.5, simultaneously Sonication assisted treatment, and supersonic frequency 25kHz, power 500W, each 20min, repeat 3 times, obtain extracting solution;
4) extracting solution aperture step 3) obtained is the Al of 0.8 μm 2o 3ceramic membrane carries out microfiltration process, and operation pressure reduction is 0.12MPa, and then filtrate is carried out vacuum concentration 60 DEG C time, vacuum is 0.095MPa, is concentrated into 13% of former filtrate volume, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains the nanoscale Chinese medicine microgranule that particle diameter is 60 ~ 80nm, autoclaving, packs and obtain free decoction agent.
Below by experiment embodiment, beneficial effect of the present invention is described.
Drug efficacy study
1, to treat the oral traditional Chinese medicine decoction of cold, fever
Chinese medicine formula: Folium Isatidis 36 parts, Flos Lonicerae 18 parts, Rhizoma Et Radix Notopterygii 9 parts, Rhizoma Bistortae 9 parts, Radix Et Rhizoma Rhei 9 parts.
Contrast method: get it filled with above-mentioned formula, adds in Decocting pot to decoct and makes decoction I, take according to quantity.
The inventive method 1: extracting honeysuckle 18 parts, Rhizoma Et Radix Notopterygii 9 parts, Rhizoma Bistortae 9 parts, Radix Et Rhizoma Rhei 9 parts add decoction in Decocting pot and make decoction; By this method (concrete grammar is with embodiment 3) formula middle period class Chinese crude drug Folium Isatidis 36 parts made and exempt from decoct; Add exempting from decoct in the decoction that all the other Chinese medicines make, stirring and dissolving, makes decoction II.
The inventive method 2: extracting honeysuckle 18 parts, Rhizoma Et Radix Notopterygii 9 parts, Rhizoma Bistortae 9 parts, Radix Et Rhizoma Rhei 9 parts add decoction in Decocting pot and make decoction; Formula middle period class Chinese crude drug consumption is reduced to Folium Isatidis 32 parts, makes exempt from decoct by this method (concrete grammar is with embodiment 3); Add exempting from decoct in the decoction that all the other Chinese medicines make, stirring and dissolving, makes decoction III.
Lanqin oral solutions:
Choose 90 routine cold, fever patients, the age is all between 20 ~ 50 years old.
Above-mentioned 90 routine patients are divided into 3 groups at random, often organize 30 examples and take decoction I (matched group), decoction II (experimental group 1) and decoction III (experimental group 2), for three days on end course for the treatment of by same dose respectively.
Statistics curative effect is as table 1.
Table 1 liang group Clinical efficacy comparison
As can be seen from Table 1; experimental group 1 and experimental group 2 curative effect are better than matched group; namely decoction II that this method makes is taken and decoction III curative effect is better than decoction I; decoction III curative effect when medicinal raw material consumption reduces still is better than decoction I; illustrate that leaf class Chinese crude drug prepared according to the methods of the invention exempts from the drug effect maintenance of decoct better, active component obtains effective protection and extracts.
2, for a kind of compound granule for the treatment of stagnation of QI constipation
Chinese medicine formula: Radix Bupleuri 10 parts, Radix Scutellariae 3 parts, Radix Angelicae Sinensis 4 parts, the Radix Astragali 10 parts, Radix Polygoni Multiflori 6 parts, Fructus Aurantii Immaturus 10 parts, Radix Polygalae 5 parts, Rhizoma Acori Graminei 5 parts, Radix Et Rhizoma Rhei 1 part, Radix Salviae Miltiorrhizae 1 part, Fructus Cannabis 1 part, 10 parts, Fructus Jujubae, Folium Sennae 5 parts, banana chip 10 parts, Radix Asparagi 10 parts.
Contrast method: 1) Radix Bupleuri 10 parts is put into white vinegar and soak 1 day, taking-up is dried stand-by; 2) gained Radix Bupleuri (processed with vinegar) in step 1) and Radix Scutellariae 3 parts, Radix Angelicae Sinensis 4 parts, the Radix Astragali 10 parts, Radix Polygoni Multiflori 6 parts, Fructus Aurantii Immaturus 10 parts, Radix Polygalae 5 parts, Rhizoma Acori Graminei 5 parts, Radix Et Rhizoma Rhei 1 part, banana chip 10 parts and Radix Asparagi 10 parts are ground into smalls, cross 120 mesh sieves; 3) Folium Sennae 5 parts, Radix Salviae Miltiorrhizae 1 part, Fructus Cannabis 1 part and 10 parts, the Fructus Jujubae warm water that temperature is 20 DEG C are soaked 2 hours, water consumption be Folium Sennae, Radix Salviae Miltiorrhizae, Fructus Cannabis and Fructus Jujubae gross weight 2 times; 4) step 3) gained mixed liquor is heated to boiling, continues to filter after 1 hour, gained concentrating filter liquor is obtained concentrated solution to 1/2 of original volume; 5) by step 2) in gained smalls pour in the concentrated solution of step 4) gained, fully stir into thick paste, thick paste dried 1 ~ 2 hour, obtains drying object, dry at temperature is 70 DEG C; 6) step 5) gains are prepared into granule I.
The inventive method 1: first formula middle period class Chinese crude drug Folium Sennae 5 parts is prepared into according to the inventive method and exempts from decoct (concrete grammar is with embodiment 4); Radix Bupleuri 10 parts, Radix Scutellariae 3 parts, Radix Angelicae Sinensis 4 parts, the Radix Astragali 10 parts, Radix Polygoni Multiflori 6 parts, Fructus Aurantii Immaturus 10 parts, Radix Polygalae 5 parts, Rhizoma Acori Graminei 5 parts, Radix Et Rhizoma Rhei 1 part, Radix Salviae Miltiorrhizae 1 part, Fructus Cannabis 1 part, 10 parts, Fructus Jujubae, banana chip 10 parts, Radix Asparagi 10 parts are processed to step 4) according to contrast method step 1), by step 2) in gained smalls and this method gained Folium Sennae exempt from decoct and add in concentrated solution, fully stir into thick paste, thick paste is dried 1 ~ 2 hour, obtain drying object, dry at temperature is 70 DEG C, be prepared into granule II.
The inventive method 2: formula middle period class Chinese crude drug consumption is reduced to Folium Sennae 4.5 parts, is prepared into according to the inventive method and exempts from decoct (concrete grammar is with embodiment 4); Radix Bupleuri 10 parts, Radix Scutellariae 3 parts, Radix Angelicae Sinensis 4 parts, the Radix Astragali 10 parts, Radix Polygoni Multiflori 6 parts, Fructus Aurantii Immaturus 10 parts, Radix Polygalae 5 parts, Rhizoma Acori Graminei 5 parts, Radix Et Rhizoma Rhei 1 part, Radix Salviae Miltiorrhizae 1 part, Fructus Cannabis 1 part, 10 parts, Fructus Jujubae, banana chip 10 parts, Radix Asparagi 10 parts are processed to step 4) according to contrast method step 1), by step 2) in gained smalls and this method gained Folium Sennae exempt from decoct and add in concentrated solution, fully stir into thick paste, thick paste is dried 1 ~ 2 hour, obtain drying object, dry at temperature is 70 DEG C, be prepared into granule III.
Lanqin oral solutions:
Choose 150 routine stagnation of QI constipation patients, the age is between 25 ~ 55 years old.
Above-mentioned 150 routine patients are divided into 3 groups at random, and often organize 50 examples and take granule I (matched group), granule II (experimental group 1) and granule III (experimental group 2) by same dose respectively, continuous 20 days is a course for the treatment of, takes two courses for the treatment of continuously.
Statistics curative effect is as table 2.
Table 2 liang group Clinical efficacy comparison
As can be seen from Table 2; experimental group 1 and experimental group 2 curative effect are better than matched group; namely granule II that this method makes is taken and granule III curative effect is better than granule I; granule III curative effect when medicinal raw material consumption reduces still is better than granule I; illustrate that leaf class Chinese crude drug prepared according to the methods of the invention exempts from the drug effect maintenance of decoct better, active component obtains effective protection and extracts.
Above-mentioned clinical research can obviously be found out, leaf class Chinese crude drug prepared by the present invention is exempted from decoct and can be applied to preparation compound Chinese medicinal preparation, namely Chinese medicine decoction, granule can be prepared into, same, also can be prepared into tablet, capsule, injection, powder, unguentum and pill, not enumerate in this application; And evident in efficacy, be obviously better than conventional directly decoction gained Chinese medicine preparation.

Claims (9)

1. leaf class Chinese crude drug exempts from a preparation method for decoct, it is characterized in that, comprises the following steps:
1) leaf class Chinese crude drug is picked up clean roguing, dry;
2) dried traditional Chinese medicine powder is broken into the Chinese crude drug fine powder that particle diameter is 100 ~ 200 μm;
3) in step 2) add the water of its volume 5 ~ 10 times amount in the Chinese crude drug fine powder that obtains, under 40 ~ 55 DEG C of conditions, soak 30 ~ 90min, the cellulase then adding Chinese crude drug fine powder weight 0.3% ~ 1.2% carries out enzymolysis, Sonication assisted treatment, obtains extracting solution;
4) extracting solution step 3) obtained carries out microfiltration process, then enters concentrator and concentrates, and concentrated solution spraying dry is obtained spray drying powder;
5) spray drying powder nanometer collider pulverizing step 4) obtained, obtains nanoscale Chinese medicine microgranule, sterilizing, packs and obtain free decoction agent.
2. a kind of leaf class Chinese crude drug as claimed in claim 1 exempts from the preparation method of decoct, it is characterized in that: in described step 3), enzymatic hydrolysis condition is: enzyme activity is 1 × 10 4u/g, hydrolysis temperature 40 ~ 55 DEG C, pH is 4.0 ~ 5.5, enzymolysis time 60 ~ 120min.
3. a kind of leaf class Chinese crude drug as claimed in claim 1 exempts from the preparation method of decoct, and it is characterized in that: in described step 3), supersonic treatment condition is: supersonic frequency 15 ~ 25kHz, power 300 ~ 500W, time 10 ~ 20min, number of repetition is 2 ~ 3 times.
4. a kind of leaf class Chinese crude drug as claimed in claim 1 exempts from the preparation method of decoct, it is characterized in that: in described step 4), microfiltration is Al 2o 3microfiltration of ceramic membrane process, Al 2o 3ceramic membrane aperture is 0.3 ~ 0.8 μm, and operation pressure reduction is 0.05 ~ 0.12MPa.
5. a kind of leaf class Chinese crude drug as claimed in claim 1 exempts from the preparation method of decoct, it is characterized in that: concentrated in described step 4) is that filtrate is carried out vacuum concentration 50 ~ 60 DEG C time, vacuum is 0.085 ~ 0.095MPa, is concentrated into 10% ~ 13% of former filtrate volume.
6. a kind of leaf class Chinese crude drug as claimed in claim 1 exempts from the preparation method of decoct, it is characterized in that: in described step 5), the particle diameter of nanoscale Chinese medicine microgranule is 60 ~ 80nm.
7. a kind of leaf class Chinese crude drug as claimed in claim 1 exempts from the preparation method of decoct, it is characterized in that: in described step 5), sterilizing methods is ultraviolet disinfection, autoclaving or ozone sterilization.
8. the leaf class Chinese crude drug as described in any one of claim 1 ~ 7 exempts from the application of decoct in preparation compound Chinese medicinal preparation, it is characterized in that: leaf class Chinese crude drug is exempted from decoct and directly adds in compound Chinese medicinal preparation, make pharmaceutically useful dosage form.
9. leaf class Chinese crude drug as claimed in claim 8 exempts from the application of decoct in preparation compound Chinese medicinal preparation, it is characterized in that: described dosage form comprises decoction, granule, tablet, capsule, injection, powder, unguentum and pill.
CN201510635626.4A 2015-09-30 2015-09-30 Preparation method and application of leaf type traditional Chinese medicinal material granules Pending CN105168141A (en)

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张春盛: "中药配方颗粒的研究现状与市场前景", 《中国中医药现代远程教育》 *
王剑文等: "酶法辅助强化中药提取过程研究进展", 《生物加工过程》 *
魏凤玉等: "无机陶瓷膜微滤技术澄清中药水提液的研究", 《中成药》 *

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Application publication date: 20151223