Radix aconiti lateralis praeparata slice formula granules and preparation method thereof

Abstract

The invention provides radix aconiti lateralis praeparata slice formula granules and a preparation method thereof, and the preparation method comprises the steps of decocting, extracting, concentrating, drying and granulating radix aconiti lateralis praeparata slices in sequence to obtain the radix aconiti lateralis praeparata slice formula granules. Wherein the decocting and extracting step comprises the following steps of: putting radix aconiti lateralis preparata slices into boiling water in an extracting tank; sequentially carrying out three times of extraction, combining the extracting solutions obtained by each time of extraction, and filtering to obtain radix aconiti lateralis praeparata slice filtrate. The preparation method solves the technical problem of low extraction rate of benzoyl mesaconitine, benzoyl aconitine and benzoyl hypaconitine in the existing preparation method of the radix aconiti lateralis praeparata tablet formula granules.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine formula granules, in particular to a preparation method of aconite root formula granules and the aconite root formula granules. Background Art

[0002] Fupian (Fu Pian) is a thin, flake-shaped medicinal material made from aconite root through soaking, steaming, and slicing. Depending on the processing method, it is classified as Heishunpian, Baifu Pian, and Danfu Pian. An existing formula granule for Fupian (Heishunpian) is made from the raw Fupian root through soaking, decoction extraction, concentration, drying, and granulation. Under the existing extraction process, the extraction rate of benzoylmesaconitine, benzoylmesaconitine, and benzoylhypaconitine from Fupian is low, which affects the transfer rate of benzoylmesaconitine, benzoylmesaconitine, and benzoylhypaconitine, which is only approximately 23%. Summary of the Invention

[0003] In view of the above problems, the present invention is proposed to provide a method for preparing aconite formula granules and aconite formula granules that overcome the above problems or at least partially solve the above problems. It can solve the technical problem of low extraction rate of benzoylmesaconitine, benzoylmesaconitine and benzoylhyaconitine in the existing preparation method of aconite formula granules, so as to achieve the purpose of improving the quality of aconite formula granules.

[0004] Specifically, the present invention provides a method for preparing aconite root formula granules, comprising: sequentially subjecting aconite root to the steps of decocting, extracting, concentrating, drying and granulating to obtain aconite root formula granules; Wherein, the decoction and extraction step comprises: Place the aconite root into the boiling water in the extraction tank; The extraction was performed three times in sequence, and the extracts obtained from each extraction were combined and filtered to obtain the aconite root filtrate.

[0005] Optionally, during the decoction extraction step: During the first extraction, the extraction time is 0.5h to 1h, and the amount of water added to the extraction tank is 10 to 15 times the weight of the aconite root; During the second extraction, the extraction time is 0.5h to 1h, and the amount of water added to the extraction tank is 8 to 12 times the weight of the aconite root; During the third extraction, the extraction time is 0.5h to 1h, and the amount of water added to the extraction tank is 8 to 12 times the weight of the aconite root; Among them, the amount of water added in the first extraction>the amount of water added in the second extraction≥the amount of water added in the third extraction.

[0006] Optionally, during the decoction extraction step: During the first extraction, the extraction time is 1 hour, and the amount of water added to the extraction tank is 12 times the weight of the aconite root; In the second extraction, the extraction time is 0.5 h, and the amount of water added in the extraction tank is 10 times the weight of the said attached tablets; In the third extraction, the extraction time is 0.5 h, and the amount of water added in the extraction tank is 10 times the weight of the said attached tablets.

[0007] Optionally, the concentration step comprises concentrating the attached tablet filtrate to obtain concentrated medicinal paste. The drying step comprises mixing the concentrated medicinal paste with auxiliary materials and then performing spray drying to obtain dry paste powder. The granulation step comprises taking the dry paste powder and performing dry compression granulation to obtain attached tablet formula granules.

[0008] Optionally, the amount of the auxiliary materials is 3% to 5% of the amount of the attached tablets.

[0009] Optionally, in the concentration step, the steam pressure is not more than 0.12 MPa, the vacuum degree is -0.03 to -0.09 MPa, the concentration temperature is 50 to 85℃, and the relative density of the concentrated medicinal paste at 60 to 70℃ is 1.01 to 1.10. In the drying step, the inlet air temperature is 120 to 180℃, the outlet air temperature is 80 to 110℃, and the liquid inlet frequency is 5.0 to 30.0 Hz. In the granulation step, dry compression granulation is adopted, the screen mesh number of the granulator is 12 meshes, the screen mesh number for sizing is 10 meshes and 40 meshes, the material conveying speed is 20 to 230 r / min, the speed of the compression wheel is 3 to 40 r / min, and the sizing speed is 20 to 230 r / min; and the weight ratio of the dry paste powder to dextrin during the granulation process is 1:0 to 1:1. The sum of the amount of the dextrin and the amount of the auxiliary materials is ≤9% of the amount of the attached tablets.

[0010] In another aspect, the present application also provides an attached tablet formula granule prepared by using the preparation method of any one of the above-mentioned methods.

[0011] The present application has the following beneficial effects: The preparation method of the prepared Fufang granules comprises the steps of decocting and extracting, concentrating, drying and granulating the Fufang in sequence to obtain the Fufang granules. The preparation method of the present application eliminates the soaking step and directly performs the decocting and extracting step, thereby significantly shortening the production cycle and improving the preparation efficiency. Further, in the decocting and extracting step, the boiling water feeding and three-time extraction process are adopted. The boiling water feeding can quickly break the tissue of the medicinal materials, which is beneficial to the dissolution of the effective components. In addition, the three-time extraction process can more efficiently and completely extract benzoyl neo-lappaconitine, benzoyl lappaconitine and benzoyl hypaconitine in the Fufang. The total transfer rate of benzoyl neo-lappaconitine, benzoyl lappaconitine and benzoyl hypaconitine is significantly improved, and the extract yield is also significantly improved. This ensures that the content of the target effective components in the finally prepared Fufang granules is stable and meets the standards, and significantly improves the quality of the product.

[0012] Further, under the process conditions of "the extraction time of the first extraction is 1 h, the water amount is 12 times the weight of the Fufang; the extraction time of the second extraction is 0.5 h, the water amount is 10 times the weight of the Fufang; the extraction time of the third extraction is 0.5 h, and the water amount in the extraction tank is 10 times the weight of the Fufang", the dry extract has a high extract yield of 12.1%, the total amount of benzoyl neo-lappaconitine, benzoyl lappaconitine and benzoyl hypaconitine in the dry extract powder is 1.26 mg / g, and the total content transfer rate of benzoyl neo-lappaconitine, benzoyl lappaconitine and benzoyl hypaconitine is as high as 48.2%.

[0013] The above and other objects, advantages and features of the present application will become more apparent from the following detailed description of some embodiments thereof, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0014] Some specific embodiments of the present application will be described in detail below with reference to the accompanying drawings, which are presented by way of illustration and not of limitation. The same reference numbers in the drawings indicate the same or similar components or parts. It should be understood by those skilled in the art that the drawings are not necessarily drawn to scale. In the drawings: Figure 1 is a schematic structural diagram of the preparation method of the Fufang granules according to one embodiment of the present application. DETAILED DESCRIPTION

[0015] The following will be described below with reference to Figure 1The tablet granules and the preparation method thereof according to the embodiments of the present application are described below. In the description of the embodiments, it should be understood that the terms "first", "second", "third" and the like are used to describe various corresponding components but are not used to describe their sequence or relative importance. Thus, a component referred to as the "first", "second", "third" component can include at least one of the component and can also include more than one of the component. In the description of the present application, the term "multiple" means at least two, for example, two, three, and the like, unless otherwise specifically limited. When a certain component "includes" or "comprises" a certain or certain components, unless otherwise specifically described, it indicates that other components can be further included and can not exclude other components.

[0016] In the description of the embodiments, the description of the terms "one embodiment", "some embodiments", "exemplary embodiment", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the present specification, the exemplary description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0017] As shown in Figure 1 The present application provides a preparation method of tablet granules, which comprises the steps of decocting and extracting, concentrating, drying and granulating the tablet in sequence to obtain the tablet granules.

[0018] The decocting and extracting step comprises: putting the tablet into boiling water in an extraction tank; sequentially extracting three times, and combining the extraction liquid obtained each time, and then filtering to obtain the tablet filtrate.

[0019] In the present embodiment, the attached pieces are sequentially subjected to decoction extraction, concentration, drying and granulation steps to obtain attached piece formula granules. In the preparation method of the present application, the decoction extraction step is directly performed; and in the decoction extraction step, the process of feeding with boiling water and three times of extraction is adopted. On the one hand, the preparation method saves the soaking step and directly performs the decoction extraction step, significantly shortens the production cycle and improves the preparation efficiency. On the other hand, in the decoction extraction step, the process of feeding with boiling water and three times of extraction is adopted. By feeding with boiling water, the medicinal material tissue can be quickly broken, which is beneficial to the dissolution of effective components; in addition, the three times of extraction process is adopted, which can more efficiently and completely extract benzoyl neoforimune, benzoyl protopine and benzoyl hypopine in the attached pieces. Under this method, the total transfer rate of benzoyl neoforimune, benzoyl protopine and benzoyl hypopine is significantly improved, and the extract yield is also significantly improved. This ensures that the content of the target effective component in the finally prepared attached piece formula granules is stable and meets the standard, and significantly improves the quality of the product.

[0020] In some optional embodiments of the present application, in the decoction extraction step: in the first extraction, the extraction time is 0.5h to 1h (for example: 0.5h, 0.6h, 0.8h, 0.9h or 1h), and the amount of water added in the extraction tank is 10 to 15 times (for example: 10 times, 11 times, 12 times, 13 times, 14 times or 15 times) the weight of the attached pieces. In the second extraction, the extraction time is 0.5h to 1h (for example: 0.5h, 0.6h, 0.8h, 0.9h or 1h), and the amount of water added in the extraction tank is 8 to 12 times (for example: 8 times, 9 times, 10 times, 11 times or 12 times) the weight of the attached pieces. In the third extraction, the extraction time is 0.5h to 1h (for example: 0.5h, 0.6h, 0.8h, 0.9h or 1h), and the amount of water added in the extraction tank is 8 to 12 times (for example: 8 times, 9 times, 10 times, 11 times or 12 times) the weight of the attached pieces. Among them, the amount of water added in the first extraction > the amount of water added in the second extraction ≥ the amount of water added in the third extraction.

[0021] The present embodiment defines the specific time range (0.5h to 1h) and gradient water addition amount (10 to 15 times the weight of medicinal materials for the first time, and 8 to 12 times the weight of medicinal materials for the last two times) of each extraction. On the one hand, it can standardize the process operation and has high repeatability, ensuring production stability and batch consistency. On the other hand, the gradient water addition amount is more scientific and economical, which not only ensures sufficient extraction in the first decoction, but also reduces the water amount in the last two decoctions, significantly reduces the subsequent concentration energy consumption, and improves the overall production efficiency. On the other hand, the precisely controlled extraction time range helps to balance the thermal stability and impurity control while fully extracting the target alkaloids (benzoyl neoforimune, benzoyl protopine and benzoyl hypopine), and more stably and reliably realizes high extraction rate, high transfer rate and high extract yield.

[0022] In some optional embodiments of the present application, in the decoction extraction step: in the first extraction, the extraction time is 1 h, and the amount of water added in the extraction tank is 12 times the weight of the attached pieces; in the second extraction, the extraction time is 0.5 h, and the amount of water added in the extraction tank is 10 times the weight of the attached pieces; in the third extraction, the extraction time is 0.5 h, and the amount of water added in the extraction tank is 10 times the weight of the attached pieces.

[0023] In the present embodiment, the above-mentioned parameter combination is the optimal process parameter verified by optimization, and under the process parameter, high target alkaloid extraction efficiency / transfer rate and / or optimal extract yield can be achieved.

[0024] In some optional embodiments of the present application, the concentrating step comprises concentrating the attached piece filtrate to obtain a concentrated medicinal paste.

[0025] The drying step comprises mixing the concentrated medicinal paste with excipients and then performing spray drying to obtain a dry paste powder.

[0026] The granulating step comprises dry pressing the dry paste powder to obtain attached piece formula granules.

[0027] In some optional embodiments of the present application, in the drying step, the amount of excipients is 3% to 5% of the amount of the attached pieces. Preferably, the amount of excipients is 5% of the amount of the attached pieces.

[0028] In the present embodiment, 5% of excipients (such as malt dextrin, lactose, etc.) as carriers can significantly improve the physical properties of the concentrated medicinal paste: reduce the viscosity, improve the atomization efficiency; prevent the material from sticking to the wall during high-temperature spraying; and reduce the degradation of heat-sensitive alkaloids during the drying process. Experiments show that when the amount of excipients is less than 5%, the viscosity of the medicinal paste is too high, which easily leads to uneven spraying; and when the amount of excipients is more than 5%, the flowability is better, but the active ingredients are diluted too much. 5% is the critical optimal value, which takes into account the process feasibility and the retention rate of ingredients.

[0029] In some optional embodiments of the present application, in the concentrating step: the steam pressure is not more than 0.12 MPa, the vacuum degree is -0.03 to -0.09 MPa, the concentration temperature is 50 to 85℃, and the relative density of the concentrated medicinal paste at 60 to 70℃ is 1.01 to 1.10.

[0030] In the present embodiment, the concentrated medicinal paste can also be called an extract. In the preparation of the extract, steam pressure, concentration temperature, and relative density (specific gravity) are three core parameters, which have important influences on the quality and production efficiency of the extract.

[0031] The steam pressure refers to the pressure of the steam generated by the steam generator or the steam boiler during the concentration process. The steam pressure directly affects the temperature of the steam and the heat transfer efficiency. Generally speaking, the higher the steam pressure, the higher the steam temperature and the higher the heat transfer efficiency, thereby accelerating the concentration speed of the extract. However, excessively high steam pressure can also cause some components in the extract to be destroyed or volatilized. The present embodiment selects a suitable steam pressure according to the components, properties and concentration requirements of the extract, thereby ensuring the safe operation of the steam generator and the steam pipeline and avoiding safety accidents such as overpressure.

[0032] The concentration temperature refers to the temperature environment of the extract during the concentration process. The concentration temperature directly affects the evaporation rate of water in the extract and the viscosity of the extract. Generally speaking, the higher the concentration temperature, the faster the evaporation rate of water and the higher the viscosity of the extract. However, excessively high concentration temperature can cause some components in the extract to be destroyed or have adverse reactions. The present embodiment sets a suitable concentration temperature according to the components, properties and concentration requirements of the extract, thereby ensuring the accuracy and stability of the heating equipment and the temperature control system and avoiding the influence of temperature fluctuations on the quality of the extract.

[0033] The relative density refers to the ratio of the density of the extract to the density of water, which is usually used to measure the viscosity and concentration of the extract. Generally speaking, the higher the relative density, the higher the viscosity and the better the stability of the extract. However, excessively high relative density can affect the spray drying effect. The present embodiment sets a reasonable relative density, thereby ensuring the texture, stability and use effect of the extract.

[0034] Therefore, the present embodiment sets reasonable concentration process parameters, thereby not only obtaining high-quality extract, but also having high production efficiency, and further ensuring the accuracy, stability and safety of the production equipment.

[0035] In some optional embodiments of the present application, in the drying step: the inlet air temperature is 120-180℃, the outlet air temperature is 80-110℃, and the liquid inlet frequency is 5.0-30.0Hz.

[0036] In the present embodiment, the inlet air temperature refers to the temperature of the hot air flow entering the drying tower, which directly affects the heat obtained by the droplets and the rate of moisture evaporation. Setting the inlet air temperature to 120-180℃ can have a higher moisture evaporation rate, while not damaging the active ingredients in the product. The outlet air temperature determines the final state of the dried paste powder. If the outlet air temperature is too high, it can cause the product to char, melt or decompose. If the outlet air temperature is too low, it can cause the product to be in a semi-dry state, resulting in sticking or aggregation adhering to the bottom of the drying chamber. In order to avoid the influence of the outlet air temperature being too high or too low on the dried paste powder, the present embodiment sets the outlet air temperature to 80-110℃, which can obtain a dried paste powder with higher quality. The liquid inlet frequency refers to the rate of feeding the liquid into the spray drying tower, which determines the number and size of the droplets. If the liquid inlet speed is too fast, it can cause the droplets to be too large and not completely dry. If the liquid inlet speed is too slow, it can reduce the production efficiency. The present embodiment sets the liquid inlet frequency to 5-30Hz, which ensures that the droplet size is uniform and the drying effect is good.

[0037] Therefore, by setting reasonable drying process parameters, the present embodiment is conducive to controlling the preparation efficiency and quality of the dried paste powder.

[0038] In some optional embodiments of the present application, in the granulation step: the granulation adopts a dry compression granulation method, the screen mesh number of the granulator is 12 meshes, the screen mesh number for sizing is 10 meshes and 40 meshes, the material conveying speed is 20-230 r / min (for example: 20 r / min, 50 r / min, 80 r / min, 100 r / min, 150 r / min, 200 r / min, 230 r / min), the speed of the compression wheel is 3-40 r / min (for example: 3 r / min, 10 r / min, 20 r / min, 30 r / min or 40 r / min), and the sizing speed is 20-230 r / min (20 r / min, 50 r / min, 80 r / min, 100 r / min, 150 r / min, 200 r / min or 230 r / min); the weight ratio of the dried paste powder to dextrin during the granulation process is 1:0-1:1; the total amount of the dextrin and the auxiliary material is ≤9% of the feeding amount of the tablet.

[0039] In the embodiment, the granulating step specifically comprises: uniformly mixing the dry paste powder and dextrin according to a certain proportion, adding the mixed material into a dry compression granulator, adjusting parameters such as the rotation speed of the compression wheel and the compression pressure of the compression wheel to compress the material into a sheet, cutting the sheet into granules through a crushing chamber, and performing whole-granule processing on the granules through different size screens to obtain granules of the required formula. The screen mesh number directly affects the size of the granules; the lower the mesh number, the larger the granules; the higher the mesh number, the finer the granules; the embodiment can obtain granules of reasonable size by setting a reasonable screen mesh number. The material conveying speed affects the rate at which the material enters the dry compression granulator; the rotation speed of the compression wheel affects the compression time and pressure distribution of the material in the nip area of the roller; the embodiment can ensure that the material can enter the compression wheel area for compression uniformly and stably by setting a reasonable material conveying speed and compression wheel rotation speed. The proportion of the dry paste powder and the dextrin affects the formability, stability and solubility of the granules; the embodiment can ensure that the granules have good fluidity and disintegration by setting an appropriate proportion.

[0040] Therefore, the embodiment is conducive to controlling the quality and yield of the granules of the formula of the attached sheet by setting reasonable granulating working parameters.

[0041] Another aspect of the embodiment of the present application also provides a granule of the formula of the attached sheet, which is prepared by the preparation method of any one of the above embodiments.

[0042] The preparation method of the present application will be described in detail below in conjunction with specific embodiments. Embodiment 1

[0043] A preparation method of a granule of the formula of an attached sheet (Heshun sheet) comprises the following steps: Decoction extraction: the attached sheet is put into boiling water in an extraction tank; three extractions are sequentially performed, and the extraction liquids obtained in each extraction are combined and filtered to obtain an attached sheet filtrate; wherein, in the first extraction, the extraction time is 1 h, and the amount of water added in the extraction tank is 10 times the weight of the attached sheet; in the second extraction, the extraction time is 1 h, and the amount of water added in the extraction tank is 8 times the weight of the attached sheet; in the third extraction, the extraction time is 1 h, and the amount of water added in the extraction tank is 8 times the weight of the attached sheet.

[0044] Concentration: the attached sheet filtrate is concentrated to prepare a concentrated medicinal paste; wherein, the steam pressure is not more than 0.12 MPa, the vacuum degree is -0.03 to -0.09 MPa, the concentration temperature is 50 to 85℃, and the relative density of the concentrated medicinal paste at 60 to 70℃ is 1.01 to 1.10; Drying: the concentrated medicinal paste is mixed with excipients and then spray dried to prepare a dry paste powder; wherein, the inlet air temperature is 120 to 180℃, the outlet air temperature is 80 to 110℃, and the liquid inlet frequency is 5.0 to 30.0 Hz; the amount of the excipients is 3% of the amount of the attached sheet; Granulation: dry paste powder is dry-pressed to prepare the tablet granules; wherein the dry-pressing method is used for granulation, the screen mesh number of the granulator is 12 meshes, the screen mesh number of the whole granulator is 10 meshes and 40 meshes, the feeding speed is 20-230 r / min, the speed of the pressure roller is 3-40 r / min, and the whole granulator speed is 20-230 r / min; the weight ratio of the dry paste powder to dextrin is 1:0-1:1 during the granulation process. The total amount of dextrin and excipients is ≤9% of the tablet feeding amount. Example 2

[0045] A preparation method of the tablet granules includes the steps of decocting extraction, concentration, drying, and granulation. Compared with Example 1, Example 2 only differs in the extraction time in the decocting extraction step, and the other steps and parameters are the same.

[0046] In this example, the extraction time is 1 h (micro-boiling) for the first extraction, 0.5 h (micro-boiling) for the second extraction, and 0.5 h (micro-boiling) for the third extraction. Example 3

[0047] A preparation method of the tablet granules includes the steps of decocting extraction, concentration, drying, and granulation. Compared with Example 1, Example 3 only differs in the extraction time and the amount of water added in the decocting extraction step, and the amount of excipients in the drying step, and the other steps and parameters are the same.

[0048] In this example: Decocting extraction: the extraction time is 1 h (micro-boiling) for the first extraction, and the amount of water added is 12 times the weight of the tablet; the extraction time is 0.5 h (micro-boiling) for the second extraction, and the amount of water added is 10 times the weight of the tablet; the extraction time is 0.5 h (micro-boiling) for the third extraction, and the amount of water added is 10 times the weight of the tablet.

[0049] Drying: the amount of excipients is 5% of the tablet feeding amount. Example 4

[0050] A preparation method of the tablet granules includes the steps of decocting extraction, concentration, drying, and granulation. Compared with Example 1, Example 4 only differs in the extraction time and the amount of water added in the decocting extraction step, and the amount of excipients in the drying step, and the other steps and parameters are the same.

[0051] In this example: Decocting extraction: the extraction time is 1 h (micro-boiling) for the first extraction, and the amount of water added is 15 times the weight of the tablet; the extraction time is 0.5 h (micro-boiling) for the second extraction, and the amount of water added is 12 times the weight of the tablet; the extraction time is 0.5 h (micro-boiling) for the third extraction, and the amount of water added is 12 times the weight of the tablet.

[0052] Drying: the amount of auxiliary material is 5% of the feeding amount of the tablet.

[0053] Comparative Example 1 A preparation method of the tablet formula granules includes soaking, decoction extraction, concentration, drying and granulation steps. Comparative Example 1 adds a soaking step compared with Example 1, and the amount of auxiliary material in the decoction extraction step and the drying step is different, and the remaining steps and parameters are the same as those of Example 1.

[0054] In Comparative Example 1: Soaking: the soaking time is 30 min, and the soaking temperature is room temperature.

[0055] Decoction extraction: a two-time extraction process is adopted. The first extraction time is 1 h, and the water amount is 10 times the weight of the tablet. The second extraction time is 1 h, and the water amount is 8 times the weight of the tablet.

[0056] Drying: the amount of auxiliary material is 0.

[0057] Comparative Example 2 A preparation method of the tablet formula granules includes soaking, decoction extraction, concentration, drying and granulation steps. Comparative Example 2 is different from Comparative Example 1 in the decoction extraction step, and the remaining steps and parameters are the same as those of Comparative Example 1.

[0058] In Comparative Example 2: Decoction extraction: a three-time extraction process is adopted. The first extraction time is 1 h, and the water amount is 10 times the weight of the tablet. The second extraction time is 1 h, and the water amount is 8 times the weight of the tablet. The third extraction time is 1 h, and the water amount is 8 times the weight of the tablet.

[0059] Comparative Example 3 A preparation method of the tablet formula granules includes decoction extraction, concentration, drying and granulation steps. Comparative Example 3 is different from Comparative Example 2 in that the soaking step is omitted, and the remaining steps and parameters are the same as those of Comparative Example 2.

[0060] Comparative Example 4 A preparation method of the tablet formula granules includes soaking, decoction extraction, concentration, drying and granulation steps. Comparative Example is different from Comparative Example 2 in that the soaking time is increased to 1 h, and the remaining steps and parameters are the same as those of Comparative Example 2.

[0061] The dried paste powder of the tablet formula granules prepared in the above Examples 1-4 and Comparative Examples 1-4 was detected, and the results are shown in Table 1.

[0062] Table 1 Comparison of results of Examples 1-4 and Comparative Examples

[0063] By comparison, Example 3 and Example 4 increase the amount of water on the basis of Example 2, the dry extract yield has obvious change, the content transfer rate also has obvious improvement. Therefore, the boiling water feeding and the shortening of the decoction time can increase the content, increase the amount of water, can increase the dissolution of the ingredients in the medicinal materials, increase the dry extract yield, and finally increase the powder yield. Considering the production factors, saving energy, Example 3 is the best example.

[0064] Further, according to the above Example 3, 3 batches of fritillaria formula granules were produced in pilot production, and the feeding amount in the process pilot was 10 kg, and 3 batches of fritillaria formula granules dry extract powder were obtained. The test results of 3 batches of pilot samples are shown in Table 2.

[0065] Table 2 Quality inspection results of 3 batches of pilot products

[0066] As can be seen from Table 2, according to the above process, stable products can be produced, which is suitable for large-scale production.

[0067] At this point, those skilled in the art should realize that although the present application has been fully shown and described herein, many other variations or modifications in accordance with the principles of the present application can be directly determined or deduced from the disclosure of the present application without departing from the spirit and scope of the present application. Therefore, the scope of the present application should be understood and recognized as covering all these other variations or modifications.

Claims

1. A method for preparing aconite root granules, characterized in that: include: The aconite root is subjected to the steps of decoction extraction, concentration, drying and granulation in sequence to obtain aconite root formula granules; Wherein, the decoction and extraction step comprises: Place the aconite root into the boiling water in the extraction tank; The extraction was performed three times in sequence, and the extracts obtained from each extraction were combined and filtered to obtain the aconite root filtrate.

2. The method for preparing the aconite root formula granules according to claim 1, wherein: During the decoction extraction step: During the first extraction, the extraction time is 0.5h to 1h, and the amount of water added to the extraction tank is 10 to 15 times the weight of the aconite root; During the second extraction, the extraction time is 0.5h to 1h, and the amount of water added to the extraction tank is 8 to 12 times the weight of the aconite root; During the third extraction, the extraction time is 0.5h to 1h, and the amount of water added to the extraction tank is 8 to 12 times the weight of the aconite root; Among them, the amount of water added in the first extraction>the amount of water added in the second extraction≥the amount of water added in the third extraction.

3. The method for preparing the aconite root formula granules according to claim 2, wherein: During the decoction extraction step: During the first extraction, the extraction time is 1 hour, and the amount of water added to the extraction tank is 12 times the weight of the aconite root; During the second extraction, the extraction time is 0.5 h, and the amount of water added to the extraction tank is 10 times the weight of the aconite root; During the third extraction, the extraction time was 0.5 h, and the amount of water added to the extraction tank was 10 times the weight of the aconite root.

4. The method for preparing the aconite root formula granules according to claim 1, wherein: The concentration step comprises: concentrating the aconite root filtrate to prepare a concentrated ointment; The drying step comprises: mixing the concentrated ointment with auxiliary materials and spray drying the mixture to obtain dry ointment powder; The granulation step comprises: taking the dry paste powder and dry-pressing and granulating it to obtain the aconite root formula granules.

5. The method for preparing the aconite root formula granules according to claim 4, wherein: The amount of the auxiliary material is 3% to 5% of the amount of the aconite.

6. The method for preparing the aconite root formula granules according to claim 4, wherein: In the concentration step: the steam pressure does not exceed 0.12 MPa, the vacuum degree is -0.03 to -0.09 MPa, the concentration temperature is 50 to 85° C., and the relative density of the concentrated ointment at 60 to 70° C. is 1.01 to 1.10; In the drying step: the air inlet temperature is 120 to 180°C, the air outlet temperature is 80 to 110°C, and the liquid inlet frequency is 5.0 to 30.0 Hz; In the granulation step, the granulation is carried out by dry pressing granulation, the mesh size of the granulator screen is 12 mesh, the mesh size of the granulation screen is 10 mesh and 40 mesh, the feeding speed is 20 to 230 r / min, the pressing wheel speed is 3 to 40 r / min, and the granulation speed is 20 to 230 r / min; the weight ratio of the dry paste powder to the dextrin during the granulation process is 1:0 to 1:1; The sum of the amounts of the dextrin and the auxiliary materials is ≤ 9% of the amount of the aconite.

7. A kind of aconite formula granule, characterized in that: The aconite root formula granules are prepared by the preparation method described in any one of claims 1 to 6.

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