CN112891377A - Gui-thin Mongolian medicine powder formula granule and preparation method thereof - Google Patents
Gui-thin Mongolian medicine powder formula granule and preparation method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of Mongolian medicine preparations, and provides precious fine Mongolian medicine powder formula granules and a preparation method thereof. The components of the Gui fine Mongolian medicine powder formula particle provided by the invention comprise Gui fine Mongolian medicine and lactose; the preparation method provided by the invention is that the noble fine Mongolian medicine is crushed and added with lactose, and wet granulation is carried out by taking ethanol solution as a wetting agent to obtain the noble fine Mongolian medicine powder formula particles. According to the invention, the noble fine Mongolian medicine is prepared into the formula particles, so that the improvement of the dosage form of the noble fine Mongolian medicine is realized, and the problems of difficult administration, easy pollution and deterioration of the Mongolian medicine are solved; the method can completely reserve the traditional property and the medication habit of the noble fine Mongolian medicine, comprehensively improves the quality controllability and the stability of the noble fine Mongolian medicine, is convenient for accurately weighing the noble fine Mongolian medicine powder formula particles, and can solve the problems that the traditional noble fine Mongolian medicine has large dose deviation and is easy to influence the curative effect.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a noble fine Mongolian medicine powder formula granule and a preparation method thereof.
Background
Mongolian medicine is an important component of world and Chinese traditional medicine, has bright Mongolian national culture characteristics, is a traditional medicine system with long history, complete theory, reliable curative effect and unique colors, occupies an important position in national medicinal culture, not only provides medical guarantee for the reproduction and the rest of Mongolian nationalities and the health of human beings, but also makes great contribution to social progress. Western medicine is unforgetted by many modern disease restraints, and in the process of seeking solutions, the concepts of the law and law nature are returned to the public vision, and the natural attribute is the innate gene of Mongolian medicine. Therefore, national medicines including Mongolian medicines are attracting attention from the present.
The traditional formulation of Mongolian medicine decoction pieces is fine powder, namely, the original medicine is directly ground and then taken, so that the Mongolian medicine decoction pieces are extremely inconvenient to take, have the defects of extremely poor patient compliance, easy pollution and deterioration and the like, cannot meet the requirement of modern people on paying attention to the quality of life, have low market acceptance and severely restrict the development and application of Mongolian medicines. The fundamental reason for these deficiencies is that the Mongolian medicine preparation and decoction pieces are in a relatively original state, the production process is simple, the technology content is low, and the preparation technology of the traditional Chinese medicine decoction pieces cannot be simply simulated because the theory and the medicine method are unique. When the traditional Chinese medicine is prepared into the formula granules, the traditional Chinese medicine needs to be decocted and purified firstly, and then the obtained extract is used for granulating, and the method is applied to the Mongolian medicine, so that the drug effect of the Mongolian medicine can be influenced, the Mongolian medicine cannot be accurately formulated clinically, and the treatment effect is influenced.
The precious fine Mongolian medicine is a Mongolian medicine which is scarce in source, high in price and required to be stored finely, the dosage of the precious fine Mongolian medicine is extremely small and generally ranges from 0.1 g to 0.5g, the precious fine Mongolian medicine cannot be weighed accurately, the time difference of divided dosage is large, the curative effect is influenced easily, and potential safety hazards exist.
Disclosure of Invention
In view of the above, the present invention aims to provide a precious fine Mongolian medicine powder formula granule and a preparation method thereof. According to the invention, the noble fine Mongolian medicine is prepared into the formula particles, so that the improvement of the dosage form of the noble fine Mongolian medicine is realized, and the problems of difficult administration, easy pollution and deterioration of the Mongolian medicine are solved; moreover, the noble fine Mongolian medicine powder formula particles prepared by the invention are easy to accurately weigh, and potential safety hazards are avoided.
In order to achieve the above object, the present invention provides the following technical solutions:
a Gui Fine Mongolian medicinal powder granule comprises Gui fine Mongolian medicinal powder and lactose; the mass fraction of the noble fine Mongolian medicine is 8-13%, and the mass fraction of the lactose is 87-92%.
Preferably, the mass fraction of the noble fine Mongolian medicine is 10%, and the mass fraction of the lactose is 90%.
Preferably, the precious fine Mongolian medicine is used in the form of precious fine Mongolian medicine raw powder, and the mesh number of the precious fine Mongolian medicine raw powder is less than or equal to 100 meshes.
Preferably, the precious fine Mongolian medicine is artificial bezoar, buffalo horn concentrated powder, conic gymnadenia rhizome, bezoar, blumea balsamifera, cordyceps sinensis, milk conic gymnadenia rhizome, saffron, globeflower, rhododendron molle, fried wide angle, fried buffalo horn, fried antelope horn, fried rhinoceros horn, fried gentiana straminea, bear gall powder, burnt hairy antler, sandalwood, toad venom powder or musk kernel.
Preferably, the water content of the noble fine Mongolian medicine powder formula particles is less than or equal to 8 percent; the repose angle of the Gui fine Mongolian medicine powder formula particles is less than or equal to 41 degrees; the sum of the granules which do not pass through the first sieve and the granules which can pass through the fifth sieve in the fine Mongolian medicine powder formula granules is less than or equal to 15 percent.
The invention provides a preparation method of the precious fine Mongolian medicine powder formula particles, which comprises the following steps:
pulverizing and sieving the noble fine Mongolian medicine to obtain noble fine Mongolian medicine raw powder;
and mixing the noble fine Mongolian medicine raw powder, lactose and an ethanol solution, carrying out wet granulation, and drying the obtained wet granules to obtain the noble fine Mongolian medicine powder formula granules.
Preferably, the sieving is 100-mesh sieving, and the sieved substance is noble fine Mongolian medicine raw powder.
Preferably, the mixing is: firstly, mixing the noble fine Mongolian medicine raw powder and lactose for 20-40 min, and then adding an ethanol solution for stirring.
Preferably, the volume fraction of the ethanol solution is 49-51%, and the dosage ratio of the noble fine Mongolian medicine, the lactose and the ethanol solution is 8-13 g: 87-92 g: 20-30 mL.
Preferably, the mesh number of the screen used for wet granulation is 14-16 meshes.
Preferably, the drying temperature is 30-40 ℃.
Preferably, after the drying, the method further comprises the step of finishing the obtained dry particles; the mesh number of the screen for granule finishing is 18-20 meshes.
The invention provides a noble fine Mongolian medicine powder formula particle, which comprises the following components of noble fine Mongolian medicine and lactose; the mass fraction of the noble fine Mongolian medicine is 8-13%, and the mass fraction of the lactose is 87-92%. According to the invention, lactose with stable properties is used as an auxiliary material, the Gui-Chi Mongolian medicine is prepared into the formula particles, the using amount of the lactose is controlled to be about 9 times of the quality of the Gui-Chi Mongolian medicine, the obtained formula particles are equivalent to 10 times of powder of the Gui-Chi Mongolian medicine, when the Gui-Chi Mongolian medicine is used in concrete, the quality of the Gui-Chi Mongolian medicine is easier to measure, the accurate sub-dose of the Gui-Chi Mongoli; according to the invention, the fluidity, lubricity and stability of the formula particles are improved by controlling the dosage of lactose, and the obtained formula particles have high CRH value, are not easy to absorb moisture and have good stability; in addition, lactose does not influence the properties of the noble fine Mongolian medicine, can promote the dissolution of the medicine and improve the bioavailability of the noble fine Mongolian medicine, and the noble fine Mongolian medicine powder has large dosage of the lactose, almost neglects the influence of the properties of the Mongolian medicine on the yield of the granulation and has high yield of the formula granules. The invention realizes the improvement of the Mongolian medicament form, solves the problems of difficult administration, low bioavailability, easy pollution and deterioration of Mongolian medicaments, is easy to accurately weigh formula particles, and can solve the problems of large deviation of the divided dose of the traditional noble fine Mongolian medicaments and easy influence on the curative effect.
In addition, the precious fine Mongolian medicine powder formula particles provided by the invention have uniform specification and dosage form standard, can be used for clinical Mongolian medicine formula, breaks through the situation that Mongolian medicine can only be granulated by medical institutions, and comprehensively realizes Mongolian medicine clinical application, disease-causing formula and one-in-one-out-of-one-in-one prescription; when the traditional Chinese medicine preparation is taken in a decoction form, the formula particles provided by the invention can be prepared first and then decocted, so that the defect that the clinical curative effect is influenced due to the fact that the traditional Chinese medicine formula particles are missing and decocted together is overcome.
The invention also provides a preparation method of the noble fine Mongolian medicine powder formula granule. The invention directly crushes the noble fine Mongolian medicine, then adds lactose, uses ethanol solution as wetting agent, and adopts a wet granulation method to prepare the formula granules. The invention adopts ethanol solution as wetting agent, which is beneficial to granule forming, and the prepared formula granule meets the production process requirement; according to the invention, the precious fine Mongolian medicine raw powder is adopted to prepare the formula particles, and decoction or purification is not needed, so that the traditional properties and the medication habits of precious fine Mongolian medicines can be completely reserved, volatile components are protected to a greater extent, the quality controllability of precious fine Mongolian medicines is comprehensively improved, and the safety and the effectiveness of precious fine Mongolian medicines are ensured; the precious fine Mongolian medicine raw powder which is crushed and sieved is adopted for granulation, the granules of the precious fine Mongolian medicine raw powder which is crushed and sieved are fine, the dissolution rate in the gastrointestinal tract is high, and the bioavailability of the precious fine Mongolian medicine can be further improved. In addition, the preparation method adopted by the invention has the advantages of simple process flow, low cost, capability of realizing large-scale production, possibility of comprehensively realizing industrialization of the Mongolian medicine and low preparation cost.
Drawings
FIG. 1 is a general process flow diagram for preparing the noble fine Mongolian medicine powder formula particles (taking bear gall powder as an example).
Detailed Description
The invention provides a noble fine Mongolian medicine powder formula particle, which comprises the components of noble fine Mongolian medicine and lactose.
In the present invention, the mass fraction of the noble fine Mongolian drug is preferably 8 to 13%, more preferably 9 to 11%, and most preferably 10%, and the mass fraction of the lactose is preferably 87 to 92%, more preferably 89 to 91%, and most preferably 90%.
In the present invention, the noble fine Mongolian medicine is preferably used in the form of noble fine Mongolian medicine raw powder, and the mesh number of the noble fine Mongolian medicine raw powder is preferably less than or equal to 100 meshes, and more preferably less than or equal to 120 meshes.
In the present invention, the precious fine Mongolian medicine is preferably artificial bezoar, buffalo horn concentrated powder, conic gymnadenia, bezoar, blumea balsamifera, cordyceps sinensis, milk conic gymnadenia, saffron, trollflower, rhododendron molle, fried buffalo horn, fried antelope horn, fried rhinoceros horn, gentiana straminea maxim, bear gall powder, burnt hairy antler, sandalwood, toad venom powder or musk, and the precious fine Mongolian medicine powder formula particles are artificial bezoar powder formula particles, buffalo horn concentrated powder formula particles, conic gymnadenia root powder formula particles, bezoar powder formula particles, artemisia piece powder formula particles, cordyceps sinensis powder formula particles, milk conic gymnadenia powder formula particles, saffron powder formula particles, tropaeolum pollen formula particles, rhododendron molle powder formula particles, fried cornu bubali powder formula particles, fried rhinoceros powder formula particles, gentiana straminea maxim powder formula particles, bear gall powder formula particles, antler burnt hairy antler powder formula particles, ginseng powder formula particles, Sandalwood powder formula particles, toad venom powder formula particles or musk powder formula particles.
According to the invention, the dosage of the precious fine Mongolian medicine in the formula particles is less, the properties of the precious fine Mongolian medicine basically have no influence on the preparation of the formula particles, the precious fine Mongolian medicine can be divided into 3 types according to the density of precious fine Mongolian medicine raw powder, specifically, the precious fine Mongolian medicine is divided into a low density type, a medium density type and a high density type, wherein the low density type comprises bear gall powder, musk, bezoar, artificial bezoar, cordyceps sinensis, toad venom and blumea balsamifera, the medium density type comprises sandalwood, gymnadenia conus, globeflower, rhododendron molle, milk conic gymnadenia, gentiana straminea and saffron, and the high density type comprises buffalo horn concentrated powder, fried wide angle, fried buffalo horn, fried antelope horn, fried rhinoceros.
In the invention, the water content of the noble fine Mongolian medicine powder formula particles is preferably less than or equal to 8 percent, and more preferably less than or equal to 6 percent; the angle of repose of the noble fine Mongolian medicine powder formula particles is preferably less than or equal to 41 degrees, and more preferably less than or equal to 40 degrees; the sum of the granules which do not pass through the first sieve and the granules which can pass through the fifth sieve in the fine Mongolian medicine powder formula granules is less than or equal to 15 percent, preferably less than or equal to 10 percent, and more preferably less than or equal to 6.5 percent; the particle size of the Gui-Fine Mongolian medicine powder formula particles is measured by a particle size and particle size distribution method (the second method of 0982 in general rules) in Chinese pharmacopoeia (2020 edition), and the sum of particles which do not pass through a first sieve and particles which can pass through a fifth sieve does not exceed 15 percent of the total weight of a sample.
The invention also provides a preparation method of the precious fine Mongolian medicine powder formula granule, which comprises the following steps:
pulverizing and sieving the noble fine Mongolian medicine to obtain noble fine Mongolian medicine raw powder;
and mixing the noble fine Mongolian medicine raw powder, lactose and ethanol, carrying out wet granulation, and drying the obtained wet granules to obtain the noble fine Mongolian medicine powder formula granules.
According to the invention, the Gui-thin Mongolian medicine is crushed and sieved to obtain the Gui-thin Mongolian medicine raw powder. The invention has no special requirements on the crushing method, and the method which is well known by the technicians in the field can be adopted; in the invention, the sieving is preferably a 100-mesh sieve, and the undersize is noble fine Mongolian medicine raw powder; the screening is preferably carried out using an electromagnetic vibrating screen.
After the noble fine Mongolian medicine raw powder is obtained, the noble fine Mongolian medicine raw powder, lactose and an ethanol solution are mixed for wet granulation, and the obtained wet granules are dried to obtain the noble fine Mongolian medicine powder formula granules. In the invention, the volume fraction of the ethanol solution is preferably 49-51%, and more preferably 50%; the ethanol solution plays a role of a wetting agent, so that the viscosity of the material can be improved, and the material can meet the requirement of wet granulation. In the invention, the dosage ratio of the noble fine Mongolian medicine, the lactose and the ethanol solution is preferably 8-13 g: 87-92 g: 20-30 mL, more preferably 9-11 g: 89-91 g: 20-30 mL, and further preferably 10g:90g:25 mL.
In the invention, the mixing is preferably to mix the noble fine Mongolian medicine raw powder and the lactose for 20-40 min, preferably for 30min, and then add the ethanol solution to stir; the invention has no special requirements on the mixing method, and can uniformly mix the materials to obtain a soft material with proper viscosity.
In the invention, the mesh number of the screen mesh used for wet granulation is preferably 14-16 meshes, and more preferably 15 meshes; the wet granulation is particularly preferably: and extruding and sieving the soft material obtained by mixing to obtain wet granules with consistent particle size.
And drying the obtained wet granules, wherein the drying temperature is 30-40 ℃, more preferably 35-40 ℃, and the drying is preferably carried out until the water content of the granules is less than or equal to 8%.
After drying, the invention preferably carries out granulation on the obtained dry granules to obtain the noble fine Mongolian medicine powder formula granules; the mesh number of the screen for whole grain is preferably 18-20 meshes; the invention improves the smoothness of wet granules by granulating, thereby improving the fluidity and lubricity of the wet granules.
In a specific embodiment of the present invention, the obtained noble fine Mongolian medicine powder formula particles are preferably packaged by using an inner packaging material, then are externally packaged, and are sent for inspection after the packaging is completed, and are warehoused and stored after the inspection is qualified. In the present invention, the inspection of the noble fine Mongolian medicine powder formula granule preferably comprises dosage form inspection and quality standard identification; the inspection of the dosage form preferably comprises the inspection of granularity, moisture, difference of filling amount, filling amount and microbial limit, and all the inspection is carried out according to a method in 0104 of the general rules of the four departments of Chinese pharmacopoeia; the quality standard identification is preferably checked according to the prescription of decoction pieces of Mongolian medicine in inner Mongolia processing Standard (2020 edition).
In the present invention, the above-mentioned processes of low-temperature pulverization, sieving, mixing, wet granulation, drying, size stabilization and split charging are preferably carried out in a class D clean zone.
The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention.
Example 1
The preparation of low-density noble fine Mongolian medicine powder formula particles takes bear gall powder formula particles as a representative variety.
Preparation of bear gall powder formula particles: the raw materials comprise bear gall powder, lactose and 50% ethanol solution (hereinafter referred to as 50% ethanol solution) by volume fraction, and the dosage ratio of the raw materials is shown in table 1.
The preparation method comprises the following steps: weighing bear gall powder, crushing, and screening the crushed material by using an electromagnetic vibrating screen to obtain 100-mesh bear gall powder raw powder; mixing the bear gall powder raw powder and lactose for 30min, and then adding 50% ethanol solution for mixing to obtain a soft material; extruding the soft material, sieving with a 16-mesh sieve, drying the obtained wet granules at 40 ℃ until the water content is lower than 8%, and then grading with a 20-mesh sieve to obtain bear gall powder formula granules; subpackaging the bear gall powder formula particles by using an inner packaging material, then packaging, and warehousing for storage after the inspection is qualified. The preparation process of the bear gall powder formula particle is shown in figure 1.
Detecting the angle of repose, the CRH value (critical relative humidity) and the yield of the particles of the obtained bear gall powder formula particles, wherein the angle of repose is used for representing the fluidity and lubricity of the particles, the smaller the angle of repose is, the better the fluidity of the particles is, the more the requirement on the fluidity in the particle production process can be met, and in the specific embodiment, the angle of repose is less than or equal to 41 degrees, so that the production requirement can be considered to be met; the CRH value is used for representing the stability of the medicine, and the larger the CRH value is, the lower the hygroscopicity is, and the stability is increased; the particle yield is used for characterizing the formability and the compressibility of the soft material obtained by mixing, and the high particle yield proves that the formability and the compressibility of the soft material obtained by mixing are better. The test results are shown in Table 1.
The angle of repose and CRH value were measured in the same manner using non-granulated bear gall powder as a comparison, and the results are shown in Table 1.
TABLE 1 raw material proportion and Performance test results of bear gall powder formulation granule
According to the table 1, the addition proportion of the auxiliary material lactose can affect the fluidity, the stability and the formability of the obtained bear gall powder formula particles, wherein when the dosage ratio of the bear gall powder, the lactose and the ethanol solution is 10g:90g:25mL, the fluidity and the stability of the obtained bear gall powder formula particles are the best, and the particle yield is the highest, compared with the bear gall powder, the angle of repose of the formula particles prepared by the invention is reduced by 27.9 degrees, which shows that the material fluidity is increased, the sub-dosage is accurate, the critical relative humidity CRH value is increased by 9.5 percent, which shows that the hygroscopicity is reduced, the stability is increased, the palatability is increased, and the clinical compliance is improved. When the dosage ratio of the bear gall powder, the lactose and the 50% ethanol solution is 20g:80g:25mL and 30g:70g:25mL, the angle of repose of the particles is increased, and the yield of the particles is reduced.
In addition, when the dosage ratio of the bear gall powder to the lactose to the starch slurry is 10g:90g:25mL, the hardness and brittleness of the obtained formula particles are ideal, and the formula particles are convenient to subpackage, transport, store and use.
Comparative example 1
The fel Ursi powder granule is prepared by respectively using starch, dextrin, sugar powder and calcium phosphate as adjuvants, and 50% ethanol solution as wetting agent, wherein the dosage ratios of the raw materials, adjuvants and 50% ethanol solution are shown in Table 2.
The preparation method is the same as example 1. The angle of repose, CRH value and particle yield of the obtained bear gall powder formula particles were tested, and the results are shown in table 2.
TABLE 2 raw material ratio and Performance test results of the bear gall powder formulation granule
As can be seen from the results in Table 2, when starch, dextrin, powdered sugar and calcium phosphate were used as adjuvants, the resulting granules of the formulation did not have the desired angle of repose and the granule yield was low.
Example 2
The preparation of the medium-density precious fine Mongolian medicine powder formula particle takes the sandalwood powder formula particle as a representative variety.
Sandalwood is used as a raw material to prepare sandalwood powder formula particles, the auxiliary material is lactose, the wetting agent is 50% ethanol solution, and the dosage ratio of sandalwood, lactose and 50% ethanol solution is 10g:90g:25 mL; the preparation method is the same as example 1.
The angle of repose, CRH value, particle size, particle yield, drug content and moisture content of the resulting formulation granules were tested and the drug quality was examined and the results are shown in table 3. Wherein the particle size is determined by particle size and particle size distribution method (second method of general rule 0982) in Chinese pharmacopoeia (2020 edition), and the sum of the particles which do not pass through the first sieve and can pass through the fifth sieve is not more than 15%; the quality inspection of the medicine is carried out according to the standard under the corresponding variety item in the preparation standard of Mongolian medicine decoction pieces in inner Mongolia (2020 edition).
Example 3
The preparation of high-density quasi-noble fine Mongolian medicine powder formula particles takes buffalo horn concentrated powder formula particles as a representative variety.
The buffalo horn concentrated powder is used as a raw material to prepare the buffalo horn concentrated powder formula particles, wherein the auxiliary material is lactose, and the dosage ratio of the buffalo horn concentrated powder to the lactose to the 50% ethanol solution is 10g:90g:25 mL; the preparation method is the same as example 1.
The angle of repose, CRH value, particle size, particle yield, drug content and moisture content of the resulting formulation granules were tested and the drug quality was checked, the test methods being the same as in example 2, and the results are shown in table 3.
The particle size, drug content and water content of the bear gall powder formulation granules prepared in example 1 in which the ratio of bear gall powder, lactose and 50% ethanol solution was 10g:90g:25mL were tested, and the drug quality was checked, and the results are shown in table 3.
TABLE 3 Performance test results for Gui-Fine Mongolian powder formulation granule
According to the data in the table 3, the invention can be seen that the high, medium and low density noble fine Mongolian medicine can be prepared into the formula granules with the performance meeting the requirements by taking the lactose as the auxiliary material and the 50% ethanol solution as the wetting agent, and the granule yield is high and the medicine performance is stable.
Example 4
According to the general process, musk powder formula particles, bezoar powder formula particles, artificial bezoar powder formula particles, toad venom powder formula particles, prepared buffalo horn powder formula particles, cordyceps sinensis powder formula particles, toad venom powder formula particles, ginseng powder formula particles, tropaeolum pollen formula particles, rhododendron molle powder formula particles, milk and gymnadenia conopsea powder formula particles, fried gentiana macrophylla powder formula particles, saffron powder formula particles, fried wild ginseng powder formula particles, fried buffalo horn powder formula particles, fried cornu cervi powder formula particles, rhinoceros horn powder formula particles and burnt antler powder formula particles are prepared respectively.
The general process comprises the following steps: the dosage ratio of the noble fine Mongolian medicine raw powder, the lactose and the 50% ethanol solution is 10g to 90g to 25mL, and other conditions are the same as those in the example 1.
The repose angle, the CRH value, the granularity, the granule yield, the medicine content and the water content of the formula granules are tested, and the results show that the repose angle of the formula granules is below 40 degrees, the CRH value is above 65 percent, the granule yield can be above 96 percent, the granularity, the medicine content and the water content all meet the requirements, and the quality of the formula granules all meets the requirements in the processing specification of Mongolia Mongolian medicine decoction pieces (2020 edition).
The embodiment can show that the invention aims at 'the medicine material basis is not changed' in the research and development of the national medicine, applies the technical method of modern pharmacy, pulverizes the single-ingredient decoction pieces of the noble fine Mongolian medicine, directly adds the auxiliary materials to carry out wet granulation, prepares the novel formula granules, can be used in Mongolian medicine clinic, overcomes the defect of inconvenient administration of Mongolian medicine powder, and is beneficial to realizing clinical preparation and dialectical application; the preparation method provided by the invention is simple, is easy for industrial production, and is beneficial to realizing automation and intellectualization of complex and precise formula work with technical requirements.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (10)
1. A Gui-FIN Mongolian medicine powder formula granule is characterized in that the components comprise a Gui-FIN Mongolian medicine and lactose; the mass fraction of the noble fine Mongolian medicine is 8-13%, and the mass fraction of the lactose is 87-92%.
2. The fine precious Mongolian powder formulation granule according to claim 1, wherein the mass fraction of precious Mongolian is 10% and the mass fraction of lactose is 90%.
3. The fine precious mongolian medicine powder formulation according to claim 1 or 2, characterised in that said fine precious mongolian medicine is used in the form of a raw precious fine mongolian medicine powder having a mesh size of less than or equal to 100 mesh.
4. The precious fine Mongolian medicine powder formula particle according to claim 1 or 2, wherein the precious fine Mongolian medicine is artificial bezoar, buffalo horn concentrated powder, conic gymnadenia rhizome, bezoar, blumea, Cordyceps sinensis, milk conic gymnadenia rhizome, saffron, globeflower, Rhododendron molle, fried Wide-Angle, fried buffalo horn, fried antelope horn, fried rhinoceros horn, fried large-leaved gentian, bear gall powder, burnt pilose antler, sandalwood, toad venom powder or musk kernel.
5. The fine Mongolian powder formulation according to claim 4, wherein said fine Mongolian powder formulation has a moisture content of 8% or less; the repose angle of the Gui fine Mongolian medicine powder formula particles is less than or equal to 41 degrees; the sum of the granules which do not pass through the first sieve and the granules which can pass through the fifth sieve in the fine Mongolian medicine powder formula granules is less than or equal to 15 percent.
6. A process for preparing a fine Mongolian powder formulation according to any of claims 1 to 5, comprising the steps of:
pulverizing and sieving the noble fine Mongolian medicine to obtain noble fine Mongolian medicine raw powder;
and mixing the noble fine Mongolian medicine raw powder, lactose and an ethanol solution, carrying out wet granulation, and drying the obtained wet granules to obtain the noble fine Mongolian medicine powder formula granules.
7. The preparation method according to claim 6, wherein the sieving is 100 mesh sieving, and the undersize is precious fine Mongolian medicine raw powder.
8. The method of claim 6, wherein the mixing is: firstly, mixing noble fine Mongolian medicine raw powder and lactose for 20-40 min, and then adding an ethanol solution for stirring; the volume fraction of the ethanol solution is 49-51%, and the dosage ratio of the noble fine Mongolian medicine, the lactose and the ethanol solution is 8-13 g, 87-92 g and 20-30 mL.
9. The preparation method according to claim 6, wherein the mesh number of the screen mesh for wet granulation is 14-16 meshes;
the drying temperature is 30-40 ℃.
10. The production method according to claim 6 or 9, further comprising, after the drying, subjecting the obtained dry granules to size stabilization; the mesh number of the screen for granule finishing is 18-20 meshes.
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