CN102961582B - Compound traditional Chinese medicine superfine powder dispersion preparation and preparation method thereof - Google Patents
Compound traditional Chinese medicine superfine powder dispersion preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a compound traditional Chinese medicine superfine powder dispersion preparation and a preparation method thereof. The compound traditional Chinese medicine superfine powder dispersion preparation has the effects of supplementing Qi and nourishing Yin, and restoring pulse and promoting the secretion of saliva or body fluid. A superfine powdering technology is adopted to crush three vegetation medicinal materials, namely, ginseng, radix ophiopogonis and fructus schisandrae, in order to overcome the defects of a conventional crushing technology and a conventional preparation technology; and the industrialization of the crushing fineness superfine powdering technology for medicines of preparation and the superfine powdering technology of traditional Chinese medicines can be realized. According to the compound traditional Chinese medicine superfine powder dispersion preparation and the preparation method thereof, the superfine powder pulse activating dispersion preparation is directly used as medicine in form of superfine powder of traditional Chinese medicines, so that the loss of effective components can be avoided, the absorption of the medicine and the bioavailability can be improved, the effect is obviously improved, and the clinical effect is improved; and as the clinical effect inspection test shown, the superfine powder pulse activating dispersion preparation is superior to the pulse activating products processed by a general crushing technology and a traditional preparation technology.
Description
Technical field
The present invention relates to a kind of supplementing QI and nourishing YIN, Fu Mai herbal mixture superfine powder dispersion formulations of effect and preparation method thereof that promotes the production of body fluid that has, belong to the field of Chinese medicines.
Background technology
SHENGMAI YIN is traditional recipe, derives from ancient prescription SHENGMAI SAN, is the classics side of supplementing QI and nourishing YIN, and SHENGMAI SAN comes from " medicine origin " of 1186 the earliest, so far existing more than 800 year history.SHENGMAI YIN is made up of Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis three taste Chinese medicines, has supplementing QI for promoting the production of body fluid, and the function of astringing YIN to stop sweating cures mainly deficiency of both vital energy and Yin card.
We's control is heresy warm, summer-heat, consumption impairment of QI the moon, or the lung being damaged by lasted cough, the card of deficiency of both QI and YIN.The heresy of temperature summer-heat is attacked people, and heat steaming antiperspirant is let out, and the most easily consumes impairment of QI Tianjin, causes the card of impairment of both QI and YIN.Lung governing skin and hair, summer-heat impairing the lung gas, defends outer mistake solid, and body fluid leaks, therefore hyperhidrosis; Lung governing qi, lung qi is impaired, therefore breathe hard lazy speech, spiritlessness and weakness; Cloudy wound and deficiency of body fluid holds above, dry throat and mouth.The red few tongue of dry tongue, deficient and rapid pulse or empty thin, is resembling of impairment of both QI and YIN.Having coughed for a long time impairing the lung, deficiency of both vital energy and Yin person, also visible above-mentioned sign, controls and should promote the production of body fluid by supplementing QI and nourishing YIN.The sweet temperature QI invigorating of SHENGMAI SAN, solid de-promoting the production of body fluid, the sweet temperature of Radix Ginseng in side, beneficial vigour, tonifying the lung gas, born fluid, be to be monarch drug; Radix Ophiopogonis is sweet cold, and replenishing YIN and removing heat, the lung moistening and production of body fluid promoting, with thinking minister; Radix Ginseng, Radix Ophiopogonis are share, and the merit of supplementing QI and nourishing YIN benefit is clear.Trimethyl gallic acid temperature, the hidroschesis of astringing the lung, promoting the production of body fluid to quench thirst, be adjuvant drug.Three medicines share, and one mends a profit one holds back, and supplementing QI and nourishing YIN, promoting the production of body fluid to quench thirst, astringing YIN to stop sweating make that the multiple Tianjin of gas is raw, that perspiration stopped is cloudyly deposited, gas fills arteries and veins is multiple, therefore named " raw arteries and veins ".
Modern pharmacology drug efficacy study shows; SHENGMAI SAN has the effects such as the coronary flow, heart tonifying, protection cardiac muscle, anticoagulant function, shock, inhibition central nervous system, antiinflammatory of increasing, anticancer, mutation, prevention heatstroke, can be used for shock, myocardial infarction, angina pectoris, arrhythmia, heart failure, cardiomyopathy, hypotension, pulmonary heart disease, Keshan disease and severe pneumonia, epidemic hemorrhagic fever and diabetes etc.
Taking SHENGMAI YIN prescription as basis, the SHENGMAI YIN dosage form of having developed has SHENGMAI ZHUSHEYE, SHENGMAI YIN KOUFUYE, SHENGMAI JIAONANG and SHENGMAI KELI etc.But these formulation methods are to be all processed into through extracting by decoction pieces, and preparation process can cause the waste of active ingredient loss and medical material.Conventional processing extracting method can not effectively destroy the cellularity of medical material, and extracts active ingredients is incomplete, affects stripping, the emission and absorption of effective substance.And traditional raw arteries and veins dosage form exists, and bioavailability is low, onset is slow, drug loading is little and take the drawbacks such as inconvenient.
Summary of the invention
The object of the invention is on the basis of SHENGMAI YIN, a kind of superfine powder dispersion formulation of ' Sheng Mai ' is provided, another object of the present invention is to provide the preparation method of this superfine powder dispersion formulation of ' Sheng Mai '.For overcoming the deficiency of above traditional disintegrating process and preparation process, inventor studies by experiment, the pulverizing of above-mentioned three kinds of Chinese crude drugs is adopted to ultra micro efflorescence technology and rational prescription, realized the industrialization of preparation medical material smashing fineness ultra micro efflorescence and Chinese medicine ultra-fine powder technology.Compared with existing conventional formulation method, micronizing can effectively be destroyed the cellularity of medical material, make extracts active ingredients more complete, promote stripping, the emission and absorption of effective substance, improve the bioavailability of medical material effective substance in human body etc., save medical material, improved the drug effect of formulation of ' Sheng Mai ', also more met the theoretical requirement that Chinese medicine emphasizes that the medical material full constituent of use in prescription is used as medicine.The present invention has adopted medical material ultra micro efflorescence technology, has improved the curative effect of formulation of ' Sheng Mai '.
Traditional dosage form is as poor in the mouthfeel of the watered pill and honeyed pill, and rate of dispersion is slow, although powder onset is very fast, and easily moisture absorption caking, and also there is the poor shortcoming of mouthfeel.And the oral preparation of Chinese traditional medicinal such as capsule, concentrated pill, tablet, drop pill, although mouthfeel has larger improvement, drug loading is little, these problems directly have influence on the value of clinical efficacy and the herb resource of preparation.Chinese-medicine oral cavity rapid release dispersion formulations is directly used as medicine with Chinese crude drug superfine powder, avoids loss of effective components, and drug loading is large, and principal agent ratio can reach 30-60%, and maximum 70%, can reduce dose; In dispersion formulations oral cavity, can soften rapidly melting or dissolving, disperse soon, mouthfeel is good; Without water delivery service, in oral cavity, run into saliva and dissolve rapidly, rapid-action, absorption and the bioavailability of medicine are improved, taking convenience, gives that some function of deglutition are bad to be drunk the inconvenient patient of water intaking and take medicine convenience is provided, and is applicable to the patient of child, old man and dysphagia, also be suitable for to be developed to and suck rapid release health food, there is wide market prospect.
The present invention relates to a kind of promote the production of body fluid herbal mixture superfine powder dispersion formulations of effect of supplementing QI and nourishing YIN, Fu Mai that has, its prescription is grouped into by following one-tenth:
A, mean diameter are less than Radix Ginseng, Radix Ophiopogonis, the Fructus Schisandrae Chinensis medicated powder of 40 μ m;
B, easily melt and become oils and fats, water-soluble sugar;
Wherein, the weight ratio of crude drug is: Radix Ginseng 1-3 weight portion, Radix Ophiopogonis 2-6 weight portion, Fructus Schisandrae Chinensis 1-3 weight portion.
The present invention has the promote the production of body fluid herbal mixture superfine powder dispersion formulations of effect of supplementing QI and nourishing YIN, Fu Mai, and the weight ratio of its crude drug is preferably: Radix Ginseng 2 weight portions, Radix Ophiopogonis 2 weight portion, Fructus Schisandrae Chinensis 1 weight portion.
The present invention has supplementing QI and nourishing YIN, the promote the production of body fluid herbal mixture superfine powder dispersion formulations of effect of multiple arteries and veins, and the weight ratio of its crude drug is preferably:
Radix Ginseng 1 weight portion, Radix Ophiopogonis 2 weight portion, Fructus Schisandrae Chinensis 1 weight portion.
The present invention has supplementing QI and nourishing YIN, the promote the production of body fluid herbal mixture superfine powder dispersion formulations of effect of multiple arteries and veins, and the weight ratio of its crude drug is preferably:
Radix Ginseng 2 weight portions, Radix Ophiopogonis 3 weight portion, Fructus Schisandrae Chinensis 2 weight portions.
Preferably, the mean diameter of Radix Ginseng, Radix Ophiopogonis and Fructus Schisandrae Chinensis medicated powder is less than 35 μ m, and the best is 22-28 μ m.
Of the present invention easily melt become oils and fats be the one in hydrogenated vegetable oil, cocoa butter, cocoa butter substitute, cacaolike butter and Polyethylene Glycol, water-soluble sugar is the one in glucose, sucrose, fructose, xylitol and Sorbitol; Preferably, described easily melt become oils and fats be cocoa butter, water-soluble sugar is sucrose.
Add the 20%-28% and the 5%-10% that easily melt the quality that becomes oils and fats and water-soluble sugar and be respectively preparation gross mass; Preferably, easily melt the quality that becomes oils and fats and water-soluble sugar and be respectively 25% and 6% of preparation gross mass.
The preparation method of herbal mixture superfine powder dispersion formulations of the present invention is:
A, pulverizing medicinal materials technique:
Take by weight Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the baking oven that is put in 40-50 DEG C after only making, drying is interior with hot air drying processing 1-2 hour, and it is for subsequent use that Radix Ginseng is cut into the long section of 3-5cm;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs carry out respectively Ordinary pulverization, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis coarse powder and Fructus Schisandrae Chinensis and recipe quantity water-soluble sugar jointly carry out micronizing, obtain three taste medical materials and water-soluble sugar superfine powder mixed-powder;
B, preparation process:
Add easily melting of recipe quantity to become oils and fats and 0.05% essence, 0.2% surfactant steps A ultra micro mixed-powder, mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations.
Any in the superfine communication techniques such as the preparation method of four kinds of medical material superfine powder of the present invention can adopt existing cut micronizing, hits formula micronizing, mill formula micronizing (comprising ball milling, vibromill, stirring mill), air-flow micronizing, preferably with equipment good airproof performance, be easy to clean, crush efficiency micronizing unit high, less energy consumption pulverizes, through Full-automatic wet laser particle analyzer (Full-automatic wet laser particle analyzer, model Winner2005; Jinan Winner Particle Instrument Co., Ltd.) granulometry, the fine powder that micronizing medicine fineness is less than 50 μ m exceedes more than 90%.
The preferred micropowder vibro-grinding unit of new generation of the present invention carries out mechanical activation comminution, utilize medium (vibrating head) under the dither of agitator, produce and impact, the multiple mechanical forces such as shearing realize the pulverizing to material, advantage is to be less than 400 μ m through the medical material mean diameter of micronization processes, can realize and disposablely entirely sieving, do not need screening, medical material full constituent is used as medicine, there is crush efficiency high, sporoderm-broken rate is high, energy consumption is low, pulverizing temperature is low, easy cleaning and total enclosing operation are without features such as dust overflow, slave unit performance, adapting to GMP management etc. considers, this unit is that current Chinese crude drug is realized micronized desirable process equipment, can realize Mechatronics control, easy to use, the refrigerating plant scalable being simultaneously equipped with is pulverized temperature, alleviate the loss of thermally labile component in grinding and processing process, improve the value of medical material.
Preferably, crushed work temperature is-5 DEG C～-10 DEG C when micronizing of the present invention.
Compared with conventional dosage forms, Chinese medicine ultra-fine powder dispersion formulations of the present invention and preparation process thereof have the following advantages:
1) can not destroy the effective ingredient of medicine, more can not constitute a threat to safe medication.Medicated powder epigranular, mean diameter is less than 40 μ m, its degree of refinement does not relate to the variation in atom or molecular structure aspect, the contained pharmacodynamic substances of Chinese medicine basis is compared with former common Chinese decoction pieces or preparation, to can not there is obvious variation, and also can not affect Chinese medicine attribute, pharmacodynamic properties and function and cure mainly.
2) the present invention discharges Effective Component of Chinese Medicine completely, and effective ingredient obviously increases at gastrointestinal dissolubility, can increase absorption dissolution degree in vivo.The problems such as the present invention has changed raw arteries and veins conventional dosage forms, especially powder and has been difficult for absorbing, and bioavailability is low.Cell wall breaking rate is high, is easy to absorb, and bioavailability and raising evident in efficacy, and accelerate the drug effect time, strengthen curative effect of medication.But meanwhile, medicated powder particle diameter is too little, as be less than 10 μ m, drug powder likely directly sees through digestive tract barrier, and can disturb the absorption of intestinal wall to medicine, therefore the average all particle diameters of superfine powder of the present invention are controlled between 12-50 μ m, to reach optimum efficiency.
3) superfine powder dispersion formulations of the present invention is used as medicine with the full powder of superfine powder, raw material of Chinese medicine can all make full use of, reduce drug administration amount, saving Chinese medicaments aptitude source, retain to greatest extent ingredient, and the effect that has kept Chinese medicine decoction, has further improved formulation of ' Sheng Mai ' clinical efficacy.
4) the present invention has improved preparation process, has shortened the production cycle (as saving diafiltration, the vapor distillation etc. in SHENGMAI SAN drink preparation process), saves raw material of Chinese medicine, has reduced production cost.
5) Chinese medicine ultra-fine powder dispersion formulations drug loading is large, and principal agent ratio is 30%-60%, and maximum can reach 70%.
6) Chinese medicine dispersion formulations can soften rapidly melting or dissolving in oral cavity, disperses soon, and mouthfeel is good, is easy to carry and taking convenience.Be applicable to the patient of child, old man and dysphagia, be also suitable for to be developed to and suck rapid release health food.
The raw arteries and veins superfine powder of the present invention dispersion formulations has improved absorption and the bioavailability of medicine, and drug effect obviously increases, and clinical efficacy improves, be better than that Ordinary pulverization and the preparation of conventional formulation technique produce SHENGMAI KELI, there is obvious clinical efficacy.
Concrete embodiment
Now elaborate the present invention by following specific embodiment, but scope of the present invention is not limited in this, within the apparent change of those of ordinary skill in the art or modification are also contained in the scope of the invention.
The preparation of the raw arteries and veins dispersion formulations of embodiment 1 superfine powder
A pulverizing medicinal materials technique:
1 weight portion Radix Ginseng, 2 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 1 hour with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the sucrose of coarse powder and 1 weight portion Fructus Schisandrae Chinensis and 5% carries out cut micronizing jointly, makes medicated powder mean diameter be less than 28 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and sucrose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 20% cocoa butter and 0.05% essence, 0.2% lecithin mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 2 superfine powder
A pulverizing medicinal materials technique:
3 weight portion Radix Ginsengs, 6 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C～50 DEG C and process 1.5 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the glucose of coarse powder and 3 weight portion Fructus Schisandrae Chinensis and 10% carries out air-flow micronizing jointly, makes medicated powder mean diameter be less than 40 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and glucose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 28% hydrogenated vegetable oil and 0.05% essence, 0.2% lecithin mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 3 superfine powder
A pulverizing medicinal materials technique:
2 weight portion Radix Ginsengs, 4 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 1.2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the Sorbitol of coarse powder and 2 weight portion Fructus Schisandrae Chinensis and 8% hits formula micronizing jointly, makes medicated powder mean diameter be less than 30 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and Sorbitol superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 22% cocoa butter substitute and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 4 superfine powder
A pulverizing medicinal materials technique:
2 weight portion Radix Ginsengs, 3 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 1.5 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the fructose of coarse powder and 2 weight portion Fructus Schisandrae Chinensis and 6% grinds formula micronizing jointly, makes medicated powder mean diameter be less than 35 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and fructose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 25% Polyethylene Glycol and 0.05% essence, 0.2% lecithin mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 5 superfine powder
A pulverizing medicinal materials technique:
2 weight portion Radix Ginsengs, 2 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the sucrose of coarse powder and 1 weight portion Fructus Schisandrae Chinensis and 6% grinds formula micronizing jointly, makes medicated powder mean diameter be less than 26 μ m, and the ambient temperature of micronizing is-5 DEG C--10 DEG C, obtains three taste medical materials and sucrose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 25% cocoa butter and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 6 superfine powder
A pulverizing medicinal materials technique:
3 weight portion Radix Ginsengs, 1 weight portion are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 1.6 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the Sorbitol of coarse powder and 3 weight portion Fructus Schisandrae Chinensis and 9% carries out air-flow micronizing jointly, makes medicated powder mean diameter be less than 35 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and Sorbitol superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 26% hydrogenated vegetable oil and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 7 superfine powder
A pulverizing medicinal materials technique:
1 weight portion Radix Ginseng, 2 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the glucose of coarse powder and 3 weight portion Fructus Schisandrae Chinensis and 7% carries out cut micronizing jointly, makes medicated powder mean diameter be less than 305 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and glucose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 22% cocoa butter and 0.05% essence, 0.2% lecithin mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 8 superfine powder
A pulverizing medicinal materials technique:
3 weight portion Radix Ginsengs, 5 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the xylitol of coarse powder and 1 weight portion Fructus Schisandrae Chinensis and 8% grinds formula micronizing jointly, makes medicated powder mean diameter be less than 32 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and xylitol superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 21% cacaolike butter and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 9 superfine powder
A pulverizing medicinal materials technique:
1 weight portion Radix Ginseng, 2 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the fructose of coarse powder and 2 weight portion Fructus Schisandrae Chinensis and 9% grinds formula micronizing jointly, makes medicated powder mean diameter be less than 27 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and fructose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 28% cacaolike butter and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 10 superfine powder
A pulverizing medicinal materials technique:
1 weight portion Radix Ginseng, 2 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the glucose of coarse powder and 2 weight portion Fructus Schisandrae Chinensis and 7% grinds formula micronizing jointly, makes medicated powder mean diameter be less than 38 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and glucose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 25% cacaolike butter and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The preparation of the raw arteries and veins dispersion formulations of embodiment 11 superfine powder
A pulverizing medicinal materials technique:
1 weight portion Radix Ginseng, 2 weight portions are only made, dried Radix Ophiopogonis, be placed in the baking oven of 40 DEG C-50 DEG C and process 2 hours with hot air drying, take out, Radix Ginseng is cut into the long section of 3-5cm, for subsequent use;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs pulverize respectively, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis, the sucrose of coarse powder and 1 weight portion Fructus Schisandrae Chinensis and 5% grinds formula micronizing jointly, makes medicated powder mean diameter be less than 28 μ m, and the ambient temperature of micronizing is-5 DEG C～-10 DEG C, obtains three taste medical materials and sucrose superfine powder mixed-powder;
B, preparation process:
Steps A ultra micro mixed-powder is added to 22% cacaolike butter and 0.05% essence, 0.2% tween mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations, specification is 10g/ piece.
The raw arteries and veins dispersion formulations treatment of embodiment 12 superfine powder coronary heart diseases and angina pectoris (type of deficiency of both QI and YIN) clinical observation on the therapeutic effect
Coronary heart diseases and angina pectoris is the common disease of cardiovascular system, and this experiment is treated 92 routine Treating Patients of Angina Pectoris (type of deficiency of both QI and YIN) application SHENGMAI KELI and the raw arteries and veins dispersion formulations of superfine powder, relatively both clinical efficacies.
1, clinical data
Treating Patients of Angina Pectoris 163 examples of selecting Linyi institute of traditional Chinese medicine to accept for medical treatment year October in February, 2010 to 2011, are divided into 4 treatment groups, every group of 32 examples, matched group 35 examples at random.All cases all meets the diagnostic criteria of angina pectoris, and Chinese medical discrimination is syndrome of deficiency of both qi and yin.Two groups of patients no significant difference (P>0.05) on sex, age, the course of disease distribute, has comparability.
2, Therapeutic Method
Matched group patient take SHENGMAI KELI (sample is provided by Lunan Pharmaceutical Co., Ltd.'s laboratory, 10 grams/bag, lot number: 20101027; Formula: Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, adjuvant is sucrose), 3 times on the one, each one bag (10g), boiled water is taken after mixing it with water, and within 2 weeks, is 1 course for the treatment of.
Treat 1 to 4 group of patient and take respectively the raw arteries and veins dispersion formulations of the prepared superfine powder of the embodiment of the present invention 6,5,4 and 11,3 times on the one, each one (10g), oral cavity buccal, 2 weeks is 1 course for the treatment of.
Observation item: medication every day is forward and backward all inquires angina pectoris attacks situation in detail, and traces tranquillization and lead ECG once, treats forward and backward promoting the circulation of blood respectively, urine, feces routine test, and liver, kidney function test, observe untoward reaction.
Statistical procedures: analyze two groups of effective percentage with SPSS-10.0 statistical software, adopt χ
2inspection.
3, curative effect determinate standard and result
3.1 angina pectoris symptom criterions of therapeutical effect are formulated with reference to " the clinical trial guideline of the new Chinese medicine treatment thoracic obstruction (angina pectoris) ", effective transference cure or substantially disappearance, and III level is relieved to the standard of I level; Effective: pain attack times, degree and persistent period have obviously and alleviate, and II level is relieved to I level, and III level is relieved to II level; Invalid; Symptom is substantially identical with before treatment.
3.2 ECG curative effect evaluation criteria 1979 Angina Pectoris from Coronary Artery Disease with Therapy of Combination of TCM with Western Medicines and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria " are formulated.Effective: electrocardiogram returns to " roughly normal " (being normal range) or reaches " normal ECG "; Effective: the reduction of S-T section, more than treating rear rise 0.05mV, but do not reach normal level, shoal at the negative T wave that mainly leads (reaching 25% above person), or T ripple from smooth become upright, chamber or intraventricular block improver; Invalid: electrocardiogram is substantially identical with before treatment; Increase the weight of: S-T section is treated front reduction more than 0.05mV, mainly leading, negative T wave is deepened (reaching more than 25%), or upright T ripple flattens smoothly, smooth T ripple becomes to be inverted, and occurs ectopic cardiac rhythm, atrioventricular block or intraventricular block.
3.3 result
Angina pectoris symptom curative effect, in table 1:
Table 1 liang group angina pectoris symptom curative effect comparison
Note: treatment group and a matched group comparison, P<0.05; Treat 2 groups and 1,3,4 group of comparison for the treatment of, P<0.05.
ECG curative effect, in table 2:
Table 2 liang group ECG curative effect comparison
Note: treatment group and matched group comparison, P<0.01; Treat 2 groups and 1,3,4 group of comparison for the treatment of, P<0.05.
3.4 untoward reaction
In therapeutic process, do not find untoward reaction.Treat forward and backward carry out blood, routine urianlysis and hepatic and renal function inspection, Non Apparent Abnormality changes.
Experimental result shows, the raw arteries and veins dispersion formulations of the superfine powder of the present invention significant difference of having compared in the anginal curative effect for the treatment of coronary artery disease with deficiency of both qi and yin with common SHENGMAI KELI, illustrate that superfine powder of the present invention gives birth to the curative effect of arteries and veins dispersion formulations and be better than the raw arteries and veins product without micronizing processing and conventional formulation explained hereafter.
Claims (1)
1. the herbal mixture superfine powder dispersion formulations that supplementing QI and nourishing YIN, Fu Mai promote the production of body fluid, its prescription is grouped into by following one-tenth:
A, mean diameter are Radix Ginseng, Radix Ophiopogonis, the Fructus Schisandrae Chinensis medicated powder of 22-28 μ m;
B, easily melt change oils and fats: cocoa butter, cocoa butter substitute or the cacaolike butter of preparation gross mass 20%-28%, water-soluble sugar: glucose, sucrose, fructose, xylitol and the Sorbitol of preparation gross mass 5%-10%;
Wherein, the weight ratio of crude drug is: Radix Ginseng 2 weight portions, Radix Ophiopogonis 2 weight portion, Fructus Schisandrae Chinensis 1 weight portion.
2. herbal mixture superfine powder dispersion formulations as claimed in claim 1, it is characterized in that add and easily melt the quality that becomes oils and fats and water-soluble sugar and be respectively 25% and 6% of preparation gross mass.
3. herbal mixture superfine powder dispersion formulations as claimed in claim 1, it is characterized in that described easily melt become oils and fats be cocoa butter, water-soluble sugar is sucrose.
4. the preparation method of the herbal mixture superfine powder dispersion formulations as described in claim 1-3 any one, is characterized in that comprising the following steps:
A, pulverizing medicinal materials technique:
Take by weight Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the baking oven that is put in 40-50 DEG C after only making, drying is interior with hot air drying processing 1-2 hour, and it is for subsequent use that Radix Ginseng is cut into the long section of 3-5cm;
By dried Radix Ginseng, Radix Ophiopogonis the prepared slices of Chinese crude drugs carry out respectively Ordinary pulverization, obtain coarse powder, cross 24 mesh sieves;
By Radix Ginseng, Radix Ophiopogonis coarse powder and Fructus Schisandrae Chinensis and recipe quantity water-soluble sugar jointly carry out micronizing, obtain three taste medical materials and water-soluble sugar superfine powder mixed-powder;
B, preparation process:
Add easily melting of recipe quantity to become oils and fats and 0.05% essence, 0.2% surfactant steps A ultra micro mixed-powder, mix, refine, with grinding tool cooling forming, make Chinese medicine ultra-fine powder dispersion formulations.
5. the preparation method of herbal mixture superfine powder dispersion formulations according to claim 4, is characterized in that: described superfine grinding method can be cut micronizing, hit formula micronizing, mill formula micronizing and, comminution by gas stream.
6. the preparation method of herbal mixture superfine powder dispersion formulations according to claim 4, while it is characterized in that micronizing, crushed work temperature is-5 DEG C～-10 DEG C.
7. the preparation method of herbal mixture superfine powder dispersion formulations according to claim 4, is characterized in that described surfactant is lecithin or tween.
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| Title |
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| 卢胜明，等.固体分散技术--一种新型兽药制剂技术.《兽药与饲料添加剂》.2003,第8卷(第1期),第16-17页. * |
| 闫波,等.固体分散技术对中药制剂的影响探析.《临床合理用药》.2012,第5卷(第1B期),第177-178页. * |
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