中药处方纳米制剂再提纯增大疗效的新制剂方法

本发明中药处方纳米破壁制剂再提纯增大疗效的新制剂方法，解决了中医药处方传统高温煎熬而严重丢失维生素及生物医药元素造成的药效低、药效慢、疗程长的弊端；虽然有了把处方中药低温破壁粉碎成3000nm级超细粉而100％保留了两元素，但又发现其存在药渣子占位而不纯仍影响药效；本发明又创新地采取乙醇或纯水溶解萃取再提纯纳米药粉的新制剂工艺，将其不溶解的木质素和杂质静置沉淀，与上清药液分离，经加温乙醇挥发冷凝回收，把复方集中萃取提纯的药干粉制成胶囊、含片、口服液、冲剂、微颗粒等代替苦汤节材增效；也可广泛作为饮料食品的营养添加剂；更适用于所有中药处方办厂加工而增加了一个经济新亮点，填补了一项节材增效中药制剂技术空白。

技术领域

The invention relates to a new preparation method for improving the curative effect by re-purifying a nano preparation with a traditional Chinese medicine prescription. Chinese medicine has homology of medicine and food since ancient times, adopts nutrient vitamins and biological medicine elements which are rich in natural materials such as plants, animals, minerals and the like, and continuously provides nutrition compensation for the development and growth of human bodies! Effective prevention and treatment of injuries occurring in humans! Therefore, the adopted raw materials must be dialectically compatible according to different epidemic situations and diseases and the preparation of the raw materials is taken after being processed; the invention aims at the method and the administration mode of the traditional Chinese medicine prescription preparation, improves and innovates the method of the processing preparation which is decocted and steamed at high temperature and the mode of drinking bitter soup and eating bitter pills which are always used while inheriting and developing the traditional advantages of the traditional Chinese medicine prescription preparation, so as to improve the curative effect of the traditional Chinese medicine prescription preparation; therefore, on the basis of the emerging new low-temperature nano superfine powder preparation, the improvement and innovation of removing impurities and retaining essence by adopting the extraction and purification technology of modern biomedicine are further adopted, so that more natural vitamins and natural biomedical elements contained in medicinal materials are retained, and the more efficient medical level of saving materials and improving efficiency, treating chronic diseases, preventing and treating diseases, preventing big diseases, protecting health and promoting longevity is achieved!

背景技术

Background Art Chinese medicine is developed from Chang Bai Cao, Huang Di Nei Jing to Li Shizhen Ben Cao gang mu in Shen nong, and after five thousand years of practice, its reproduction is big till now 14 hundred million people stand on top of the world!

The modern biotechnology is urgently needed to summarize the sublimation only by inheriting the super medical skill of countless traditional Chinese medical masters in the generation to the safe driving and protecting navigation of life death and survival of Chinese nationalities and accumulating the great medical achievement of life saving and treatment of life saving organisms and foods for saving and removing injuries and five thousand years of the experience of treating diseases and saving of the traditional Chinese medicinal materials for the Shentong!

According to statistical reports, 12807 traditional Chinese medicinal materials are known, wherein the medicinal plants account for 87 percent, the medicinal animals account for 12 percent, the mineral medicines account for 1 percent, and the medicinal and edible fungi and algae are developed in recent times, however, the traditional Chinese medicinal materials are ten million prescriptions recorded inside and outside the ancient pharmacopoeia and handed down between folks, such as ancient prescriptions, imperial prescriptions, empirical prescriptions, peculiar prescriptions, secret prescriptions and good prescriptions, wherein the names of the biological elements and the components and the molecular weights of the biological elements are used for treating diseases and injuries, promoting health, promoting longevity?, and the ancient pharmacopoeia, and the like, if the detection, the inspection and the general survey can be completely finished, and the complete and accurate case of biochemical medicine science is rapidly identified and promoted to be extremely accurate!

The experience, medical skill and theory of maintaining the nature (non-chemical synthesis), combination (compound multi-flavor combination), linkage (cool and heat, purging and tonifying, yin-yang mixing), simultaneous treatment of principal and subordinate symptoms, combination of treatment and health preservation, syndrome differentiation and treatment, etc. of traditional Chinese medicine must be firmly and completely written into the new Chinese medical dictionary!

The extraction and purification technology of western medicine should be used for the purification and synergism of the traditional Chinese medicine preparation as early as possible; since ancient times, the traditional preparation method and the administration mode of the traditional Chinese medicine still use each medicine and need to be decocted for 2 to 3 times at a high temperature of 100 ℃, pour out bitter soup and discard medicine residues, so that hundreds of vitamins are almost completely lost! Heat-sensitive drugs are also lost! So that the laggard method of insufficient efficacy, low curative effect, slow curative effect, long treatment course, expense of medicinal materials and much money can be presented, and innovation and improvement are required!

At present, the method for preparing the nano superfine powder by intensively breaking the walls of a plurality of herbs in a traditional Chinese medicine prescription at low temperature is developed, the granularity of the nano superfine powder is more than 3000nm and is reduced to about 5 ten thousand meshes, so that all vitamins and biological medicine elements contained in traditional Chinese medicine medicinal materials can be completely reserved, and the purposes of saving materials and improving efficiency are achieved, but tests show that constipation can be caused when the curative effect is improved, the nano superfine powder and medicine dregs are also thrown into the traditional Chinese medicine decoction method, the medicine dregs are thrown away and are not used, the invention aims to lift dregs in the nano superfine powder, the curative effect can be improved, the dregs can be changed into wastes, and the other useful purposes are?!

发明内容

The invention relates to a novel preparation method for re-purifying and increasing curative effect of a nano preparation of a traditional Chinese medicine prescription, which is characterized in that a single preparation or a compound preparation material of the traditional Chinese medicine prescription decocted and boiled at high temperature is changed into nano dry powder subjected to wall breaking and ultrafine grinding at low temperature, and then a biochemical physical extraction and purification technology is adopted to separate medicine residues (such as plant lignin, cellulose and the like) remained in the nano dry powder, so as to strive to ensure that the vitamins and biological medical elements contained in the medicine powder are maximally and purest to remove impurities and retain essence for safe taking and improving the curative effect!

However, the current extraction and purification technology of biochemical and physical is mostly used for each material, only one element of each material can be extracted at one time and then discarded, and a new material needs to be replaced for extraction, which wastes materials and increases the cost! The traditional Chinese medicine prescription is a compound prescription, contains dozens of vitamins and medicinal elements, is not suitable for a technological method for extracting one medicine, and needs to dissolve nano powder at low temperature by using a proper solvent, clarify and separate impurities in the nano powder, and then concentrate and restore the residual compound pure solvent rich in various vitamins and medicinal elements to the original nano dry medicine powder state at one time;

the used solvent has no toxic or side effect and is easy to volatilize; the extraction process still adheres to low-temperature operation, and then the water content of the nanometer superfine dry powder before extraction is recovered to an index of 4 percent so as to prevent mildew during storage; the traditional Chinese medicine considers that the wine is the first medicine element, can not only benefit the spirit, but also help the efficacy of the wine, and can disinfect and sterilize better, so that the edible high-alcohol is better used as a solvent; but also can be purified by a wet method by using clean clear water as a solvent;

in the purification process, the ethanol solvent and the medicinal powder are poured into a transparent stirring kettle (tank) to be uniformly stirred → to be kept stand to dissolve and precipitate → to be purified in a layered way → the ethanol solvent is slightly heated (not more than 50 ℃) to promote the volatilization and gasification of the ethanol solvent → the air flow valve is opened on the upper part of the kettle → the liquid ethanol is recycled by introducing a condenser → the lower discharge valve of the kettle is opened to recycle the medicinal material → the medicinal material is sent into a drying chamber to be dried to 4% → sampling quality inspection → packaging and labeling → warehousing. All the processes and the devices thereof are made of non-toxic materials!

If distilled water or purified water is used as solvent (mineral water or tap water containing chlorine is not suitable), it is suitable for purification production by freezing vacuum radiation low-temperature drying equipment.

附图说明null实施方式

The specific implementation scheme is as follows:

the invention relates to an implementation scheme of a novel preparation method for re-purifying and increasing curative effect of a nanometer preparation of a traditional Chinese medicine prescription, which designs two process routes:

the first purification route: the following purification embodiment is further implemented by selecting edible alcohol with the alcohol content of more than 70 ℃ as a solvent of the traditional Chinese medicine nano wall-broken superfine dry powder.

Process step 1 "material selection": please refer to an old traditional Chinese medicine for helping to randomly select an effective prescription depending on traditional high-temperature cooking and decocting from the traditional Chinese medicine pharmacopoeia, the number of the medicine is not limited, but 13 kg of authentic traditional Chinese herbal medicine materials without pollution, pesticide residue and mildew are required;

the process step 2 of rapid purification, cutting and low-temperature dehydration drying: removing impurities from the required medicinal materials by hand selection, immersing the medicinal materials in a water pool for ten minutes, fishing out the medicinal materials, washing silt of the floating soil by a water pipe, cleaning, throwing away the floating water by a dehydrator, air-drying at low temperature or airing until the water content is 4% → cutting by a cutting machine to about 5 cm long → metering about 11 kg; (the field must be clean);

process step 3 'the wall-breaking nano-powder is crushed and the traditional decocting preparation is simultaneously measured and tested':

(1) purchasing a nano crusher capable of breaking walls and crushing 10 kilograms at low temperature every six hours, adjusting the granularity according to the requirement, and putting purified medicinal materials → producing 5 thousands of meshes of broken-wall superfine dry powder at low temperature in a plurality of times or once;

(2) preparing a large casserole for decocting the medicinal herbs → putting 1 kg of the purified medicinal herbs into the casserole → adding 1.5 kg of clear water → boiling with medium fire for about 1 hour, pouring out 500 g of the first medicinal soup → adding 1 kg of clear water into the casserole → boiling for 50 minutes, then adding 500 g of the medicinal soup → mixing the two medicinal soups, stirring uniformly, sending to a quality control room for assay and detection → storing the other dregs for standby;

step 4 "mixing ethanol solvent and dry nanometer powder in a ratio of 2 to 1": pouring 20 kg of more 70 DEG edible alcohol and 10 kg of superfine dry powder medicine into a transparent glass pot (kettle) → stirring uniformly, standing and precipitating for about 2-3 hours, and observing that when liquid precipitation is layered to at least show three layers, the bottom layer is obviously turbid, the middle layer is semitransparent, and the upper layer is more transparent, so that the standard is reached;

process step 5 "separation, extraction of supernatant": sucking the middle and upper layers of solution out by a suction pipe or a sucking disc and flowing into an interlayer stainless steel evaporating pot which can be sealed up and down;

process step 6 "redissolution purification": adding one time of alcohol into the third layer of turbid liquid in the glass tank according to the height of the turbid liquid → stirring, then standing for about 2 hours → sucking out the supernatant liquid of the upper layer and the middle layer, and adding the supernatant liquid into the solution obtained in the process step 5 to stir uniformly;

process step 7 "Evaporation, condensation, recovery": sending hot water heated to 50 ℃ into an interlayer of a stainless steel tank → absorbing heat by slow stirring in the tank (the stirrer needs to be made of hard wood and cannot collide with a spark to cause alcohol deflagration) → opening a deflation valve at the top of the tank before the hot water is fed in to connect an air flow pipeline → the heated and volatilized ethanol gas flows into a condenser → recovering the alcohol condensed into ethanol liquid → storing in a fireproof way, and then reusing for the next time;

process step 8 "recovery of purified nano-ultra-fine powder at bottom of stainless steel tank": after ethanol gas in the reaction kettle is volatilized, opening a valve pipe opening at the bottom of the tank → automatically dropping medicinal powder without wine liquid into a plastic bag for recycling, sending the plastic bag into a sterilization packaging workshop, sampling, sending the plastic bag into a quality inspection room for inspecting granularity and water content, sub-packaging and labeling after reaching the standard, checking and registering, and storing the plastic bag into a commodity warehouse;

process step 9 "inspection and comparison":

(1) sampling 100 g from the produced purified nano-dry powder of the traditional Chinese medicine → sending the nano-dry powder to a quality control room to detect the content data of the vitamin and the medicine;

(2) taking 100 g of 10 percent of medicine liquid (equivalent to 10 percent of nano dry powder) out of 1000 g of the total amount of the decocted preparation medicine liquid, and sending the medicine liquid to a quality control room for testing and detecting the content data of the vitamins and the medicine elements;

(3) comparing the two data detection results, the quality of the new and old preparation technology of the traditional Chinese medicine can be obtained; and the treatment effect can be relatively predicted; the data of each nanometer ultrafine powder are marked in the specification;

process step 10 "package into easy-to-take medicine": capsule, oral liquid, buccal tablet, granule, microparticle, etc.

2. The second technical process route is as follows: adopting pure water as a safe solvent for wet purification:

the process comprises the following steps: the purified traditional Chinese medicine prescription material is dehydrated and cut into sections without being dried, and can be directly put into a nano wall-breaking pulverizer to be pulverized into superfine wet powder by a wet method;

the process step 2: according to the ratio of 1: 1.5 of the superfine wet powder to the clear water, sending the superfine wet powder into a transparent or reaction stirring kettle or tank with an observation hole, uniformly stirring, standing and precipitating for about 3 hours, and when three layers are displayed, the bottom layer is obviously turbid, the middle layer is semitransparent, and the upper layer is more transparent, thus reaching the standard;

and 3, a process step: sucking out the supernatant with a suction pipe or a suction cup and flowing into another storage tank;

and 4, a process step: according to the height of the third layer of turbid liquid precipitated in the stirring kettle or the tank, injecting clear water which is 1 time higher → stirring evenly → standing and precipitating the three layers clearly → sucking out the clear liquid on the upper layer → merging into the tank in the process step 3 and stirring evenly; the remaining third layer of turbid liquid is taken out for waste utilization, so that the income is increased, and the ecological environment pollution is avoided;

and 5, a process step: sending all stored supernatant into a vacuum freezing radiation sublimation dryer to reach the dryness of 4 percent;

process step 6 "package into easy-to-take medicine": capsule, oral liquid, buccal tablet, granule, microparticle, etc.

And (4) conclusion: the purification technology of prescription drugs produced by the two new process technologies has common advantages and also has the following defects:

the first purification process route: dry wall breaking and crushing to prepare dry nanometer powder, and layered purification, impurity removal and essence retention by using high-grade edible alcohol as a solvent, so that the process is simple and convenient, equipment is saved, and the drug effect is improved; in the processing of the same kind of medicine materials, the recovered alcohol can be repeatedly used; but fire prevention measures are necessary!

The second purification process route: the method has the advantages that the dry nanometer powder is prepared by wet wall breaking and crushing, and the clear water is used as a solvent, so that the process is simple and convenient, and the fire risk is avoided; but the mechanical equipment and the labor cost are higher!

The common advantages are that although the solvents are different, the method can remove impurities from the nano-scale ultrafine powder and purify the ultrafine powder again, thereby greatly improving the reformation and innovation of the efficient novel preparation for preventing and treating diseases, protecting health and promoting longevity, thoroughly abandoning the backward preparation method of a plurality of Chinese medicinal prescriptions for thousands of years due to drinking bitter soup by high-temperature decoction, avoiding losing a large amount of vitamins and medicinal elements which are urgently needed by patients, and avoiding the loss of the vitamins and the medicinal elements which have the disadvantages of insufficient drug potency, low drug effect, slow curative effect and long treatment course, and increasing the dosage of the medicinal materials again and again when the disease condition is aggravated, and entering a passive situation of a so-called 'slowly conditioning bar', thereby delaying the disease condition and improving the condition in time!32is not an innovative reformation? with revolutionary significance once, and is convenient to take orally and fast to absorb, thereby greatly improving the curative effect, promoting health and promoting longevity, and serving the whole human with high quality!

In addition, the nano-ultrafine powder purified by removing impurities and remaining essence can also be used as a nutritional additive for various nutritional drinks and foods: for example, the beverage food such as fried instant noodles, cold noodles, mineral water, various ice creams, biscuits and the like, even the non-nutritive white spirit can be converted into the nutritive delicious food for preventing diseases and maintaining health and healthy people by taking the purified nano ultrafine powder for both medicine and food as a nutritional additive.

Impurities after the nano ultrafine powder is purified by layered separation and extraction mainly occupy 20-30% of lignin and cellulose, cannot be discarded, and can be used as wastes to prepare valuable chemical products, so that the production cost of the nano pure dry powder of the traditional Chinese medicine can be reduced, and the price of the medicine can be reduced to benefit patients. Meanwhile, a new economic bright spot is added for a wide-open prescription medicine nano-purification traditional Chinese medicine product processing factory, and the blank of a pharmaceutical technology is filled!

In a word, the modern traditional Chinese medicine has better comprehensive prevention and treatment effect, safe taking, multiple action targets, strong long-acting property and overcomes the defects of large taking dosage and unstable component quality, and the new preparation method of the nanometer preparation of the traditional Chinese medicine prescription for purifying and increasing the curative effect is the best choice for chronic diseases, preventive treatment of diseases, health care and life preservation.