CN117018133B - Continuous preparation method of lung-benefiting cough-relieving capsule - Google Patents
Continuous preparation method of lung-benefiting cough-relieving capsule Download PDFInfo
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Abstract
The invention discloses a continuous preparation method of a lung-benefiting cough-relieving capsule, which specifically comprises the following steps of: weighing seven medicinal materials including radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii, gecko, herba Centipedae and radix Stemonae according to the amount; step 2: high-temperature instantaneous sterilization; step 3: decocting herba Lysionoti Pauciflori in water twice, mixing decoctions, filtering, and concentrating; step 4: decocting radix Stemonae in water twice, mixing decoctions, filtering, and concentrating; step 5: mixing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko fine powder as base material, mixing herba Gei Albae extract and radix Stemonae extract as binder, and granulating in one step; step 6: finishing and mixing; step 7: filling the capsules; the invention realizes continuous manufacture, solves the technical problems of reduced active ingredients, large energy consumption, multiple working procedures, heavy dust and low efficiency of the original process, and improves the process and quality level of the product.
Description
Technical Field
The invention relates to the technical field of preparation of lung-benefiting and cough-relieving capsules, in particular to a continuous preparation method of a lung-benefiting and cough-relieving capsule.
Background
The lung-benefiting cough-relieving capsule is a Chinese patent medicine on the market. The main functions are as follows: nourishing yin, moistening lung, relieving cough, and eliminating phlegm, and can be used for treating acute and chronic bronchitis expectoration and hemoptysis; has adjuvant therapeutic effect on pulmonary tuberculosis and lymphoid tuberculosis.
The application number is: CN202210250463.8, publication number: the invention of CN202110944659.2 discloses a preparation device of a traditional Chinese medicine composition for tonifying lung and relieving cough, which is characterized by comprising a crushing device, an extract preparation device, a material taking device, a mixing device, an ethanol box, a diluting device, a granulating device and a drying device; the crushing device is used for respectively crushing the radix ranunculi ternati, the pseudo-ginseng, the rhizoma bletillae, the lily and the gecko into powder, the extract preparation device is used for preparing the herba lycopodii into herba lycopodii extract, preparing the radix stemonae into radix stemonae extract, and the ethanol box is used for containing ethanol; the material taking device is used for quantitatively weighing the radix ranunculi ternati, the pseudo-ginseng, the rhizoma bletillae, the lily and the gecko, sending the radix ranunculi ternati, the pseudo-ginseng, the rhizoma bletillae, the lily and the gecko into the mixing device, quantitatively weighing the ethanol, the herba lycopodii extract and the radix stemonae extract, and sending the ethanol, the herba lycopodii extract and the radix stemonae extract into the diluting device; the diluting device receives the weighed ethanol and the weighed extractum, the addition of the ethanol dilutes the chlorophytum comosum extractum and the stemona root extractum, and the diluted extractum is sent into the mixing device; the mixing device is used for mixing the powder of the catclaw, the pseudo-ginseng, the rhizoma bletillae, the lily and the gecko, and mixing the mixed traditional Chinese medicine powder with the diluted extractum to obtain a traditional Chinese medicine composition; the granulating device is used for granulating the traditional Chinese medicine composition, and the drying device is used for drying the prepared wet granules.
The original technology of the lung-benefiting and cough-relieving capsule comprises wet heat sterilization, wet granulation and oven drying, and along with the application of new technology and new equipment, the defects in the original technology are also more obvious:
firstly, the original sterilization process adopts wet heat sterilization, the characteristics of the sterilized powder are obviously changed, and the effective components of the sterilized powder are reduced. In the original preparation process of the lung-benefiting and cough-relieving capsule, a wet heat sterilization method is adopted for sterilization of the traditional Chinese medicine mixed powder, the sterilization method is subjected to high temperature for a long time, materials are adhered and agglomerated after sterilization is finished, the color is darkened, meanwhile, long-time drying is needed, the traditional Chinese medicine mixed powder can enter the next process after being crushed, and due to the fact that the high temperature is continuously maintained in the sterilization process, certain loss of active ingredients of the medicinal materials is caused, unnecessary drying and crushing processes are added, and unnecessary energy consumption and labor are further increased.
Secondly, the original granulating process adopts wet granulating and oven drying, and the target component of the stone chlorophyllin is obviously destroyed before and after granulating, which is not beneficial to the exertion of the curative effect of the product. The improvement of the transfer rate of the active ingredients in the medicinal materials plays an important role in the quality of the product, the content of the active ingredients is an important index for measuring the quality of the product, and how to transfer the active ingredients in the medicinal materials to the product to the maximum extent through mass transfer is an important basis for evaluating the rationality of the preparation process. Because the effective components of the traditional Chinese medicine are greatly influenced by long-time high temperature and high humidity, in the preparation process, a proper process is needed to avoid the influence of long-time high temperature of materials so as to improve the transfer rate of the effective components and ensure the curative effect of the preparation.
In the general process of preparation, wet granulation is usually carried out by adopting a wet granulator or a groove type mixing machine to prepare soft materials, and a swinging granulator is used for preparing wet granules, and drying by an oven or boiling drying is carried out. Because the relative density of the extractum is higher, the phenomena of difficult granulation and uneven granules exist, the weight difference is not easy to control when the capsule is filled, and meanwhile, the granulation process is long, the loss is large, the dust pollution is heavy, and the occupational sanitation protection is poor.
The high temperature instantaneous sterilization is widely applied to the sterilization of food and medicine industries, and can obtain high quality products and realize continuous production due to short heating time and the maximum reservation of original flavor.
One-step granulation is also called boiling granulation or fluidized bed granulation, and is a technology of putting materials into a closed container once, uniformly mixing the materials in the container, uniformly spraying an adhesive through equipment, fully mixing the adhesive and the materials, flowing in the container to form small particles, feeding hot air through the bottom end, drying wet particles, and finally directly collecting finished dry particles. The three steps of mixing, granulating and drying of the conventional wet granulation are finished in a closed container at one time, so that cross contamination can be avoided.
Continuous manufacturing, in which the material produced in each process step is directly and continuously sent to the next step for further processing, requires reliable production of acceptable intermediates or products, often involves a higher level of process design than batch manufacturing to ensure adequate process control and product quality, provides the possibility of improved product quality control and increased manufacturing flexibility, while reducing the waiting and interruption of the production process, ensuring steady state of the production process, reducing the variability between batches, thereby improving uniformity and stability of product quality, and greatly reducing the manufacturing cost of the pharmaceutical product, while avoiding dust pollution, and improving production efficiency, relative to batch manufacturing, relative to conventional batch manufacturing.
Disclosure of Invention
The invention aims to provide a continuous preparation method of a lung-benefiting and cough-relieving capsule, which can effectively solve the technical problems of long-time heated degradation, multiple and discontinuous working procedures, high energy consumption, heavy dust pollution, poor occupational health protection and low production efficiency of effective components of the lung-benefiting and cough-relieving capsule in the prior art, and can improve the process and quality level of products.
In order to solve the technical problems, the invention adopts the following technical scheme:
a continuous preparation method of a lung-benefiting and cough-relieving capsule specifically comprises the following steps,
step 1: weighing seven medicinal materials including radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii, gecko, herba Centipedae and radix Stemonae according to the amount;
step 2: the high-temperature instantaneous sterilization comprises the following specific sterilization steps: pulverizing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko into 50-100 mesh powder, respectively, sterilizing at 135-180deg.C for 5-20 seconds;
step 3: decocting herba Lysionoti Pauciflori with 8-12 times of water twice for 1-2 hr each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.08-1.15 at 60deg.C, and controlling the temperature of the medicinal liquid at 50-70deg.C;
step 4: decocting radix Stemonae with 8-12 times of water twice for 1-2 hr each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.08-1.15, measuring at 60deg.C, and controlling the temperature of the medicinal liquid at 50-70deg.C;
step 5: mixing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko fine powder as base material, mixing herba Centipedae extract and radix Stemonae extract as binder, granulating in one step, controlling material temperature at 60-70deg.C, and controlling water content at 2% -4%;
step 6: sieving with 18-30 mesh sieve, and mixing;
step 7: filling the capsules;
after the step 1 is finished, all materials and intermediates in the preparation process are connected by a closed pipeline, and negative pressure or vertical flow is adopted to convey to the next step, so that continuous production is realized.
Further limiting, in the step 3, the herba Centipedae is decocted in water twice, the first time is 10 times of water, the second time is 8 times of water, each time is extracted for 1.5 hours, the filtrates are combined, the filtrate is concentrated to have the relative density of 1.10, the temperature of 60 ℃ is measured, and the temperature of the liquid medicine is controlled to be 55-65 ℃.
Further limiting, in the step 4, the radix stemonae is decocted with water twice, 10 times of water is added for the first time, 8 times of water is added for the second time, each time of extraction is carried out for 1.5 hours, the filtrates are combined, the filtrate is concentrated to have the relative density of 1.10, the temperature is measured at 60 ℃, and the temperature of the liquid medicine is controlled at 55-65 ℃.
In the step 5, the material temperature is controlled to 65 ℃ and the moisture is controlled to 3 percent.
Wherein, during high temperature instant sterilization, the radix Ranunculi Ternati, the radix Notoginseng, the rhizoma bletilla, the lily and the Gecko are respectively crushed into fine powder, and the fine powder is sieved by a 100-mesh sieve, and the sterilization temperature is 150 ℃ and the sterilization time is 10 seconds.
Further defined, in step 6, the whole grain screen is 24 mesh, and the capsules are filled after total mixing.
In step 5, the parameters of the one-step granulating process are set as follows:
air inlet frequency: 25-45HZ;
feed rate: 30-60L/h;
density of extract: 1.08-1.15, measured at 60 ℃;
atomization pressure: 0.06-0.12MPa;
material temperature: 60-70 ℃.
Bag shaking frequency: 60-120S, and 3-5 times.
Compared with the prior art, the invention has the following beneficial effects:
the invention provides a proper sterilization process for the lung-benefiting and cough-relieving capsules, solves the technical problems of changed characteristics and reduced active ingredients in medicinal powder after sterilization by adopting the existing sterilization technology, and ensures the quality of the sterilized products.
Meanwhile, the invention optimizes the granulating process, improves the existing granulating process technology, takes the content index of the finished product as a control index, finally determines a one-step granulating method and process parameters, provides a granulating process suitable for the product for the lung-benefiting cough-relieving capsule, solves the technical problems that the existing wet granulating process is adopted, the target component of the stone chlorophyllin after granulating is obviously damaged, the transfer rate of the finished product is lower, improves the curative effect of the product under the condition of unchanged prescription, and improves the quality of the product.
The original granulating process is wet granulating or tank mixing and swinging granulating, the adopted adhesive is radix stemonae extract and herba lysimachiae extract, but the relative density is above 1.30, the condition of difficult granulating exists, the granule is uneven, the phenomenon of hard granule exists, and the weight difference is not easy to control when the capsule is filled; the one-step granulating method is adopted through the process improvement, so that the problem of difficulty in granulating by adopting the existing wet granulating technology is solved, commercial production is facilitated, meanwhile, the one-step granulating is adopted, the particle uniformity is better, the loading amount is stable during capsule filling, and the control is easy. In addition, the one-step granulating process is closed production, so that the production environment can be improved, and the method is more environment-friendly.
More importantly, after the process is improved, the use of a large amount of high-concentration ethanol is avoided, the explosion-proof grade of a production site can be reduced, the safety in the production process is improved, meanwhile, during granulation, the extractum is used for granulating instead of ethanol, so that materials are saved, the manufacturing cost of products is reduced, and the competitiveness of the products is improved.
The whole production process realizes sealing and serialization. The dust pollution and labor intensity are reduced, the occupational sanitation protection is enhanced, the production efficiency is improved, and a foundation is laid for intelligent manufacturing.
Drawings
FIG. 1 is a sample 1 detection pattern of the present invention.
FIG. 2 is a sample 2 detection pattern of the present invention.
FIG. 3 is a sample 3 detection pattern of the present invention.
Fig. 4 is a fingerprint of the present invention.
Detailed Description
Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
Example 1
The embodiment discloses a continuous preparation method of a lung-benefiting cough-relieving capsule, which comprises the following steps:
step 1: the raw materials comprise seven medicinal materials including radix Ranunculi Ternati, radix Notoginseng, rhizoma bletilla, bulbus Lilii, gecko, herba Centipedae and radix Stemonae;
wherein, in step 1: 80-120g of radix ranunculi ternati, 20-40g of pseudo-ginseng, 100-150g of rhizoma bletillae, 30-70g of lily, 2-6g of gecko, 20-70g of herba lycopodii and 20-40g of radix stemonae.
Further defined, in step 1,
92g of radix ranunculi ternati, 30g of pseudo-ginseng, 130g of rhizoma bletillae, 40g of lily, 3.4g of gecko, 40g of herba lycopodii and 26g of radix stemonae
Step 2: pulverizing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii, and Gecko, sieving with 50-100 mesh sieve, and sterilizing at 135-180deg.C for 5-20 s;
in particular, the sterilization method is preferable: pulverizing the above materials into fine powder, sieving with 100 mesh sieve, and standing at 150deg.C for 10 seconds.
Step 3: decocting herba Lysionoti Pauciflori with 8-12 times of water twice for 1-2 hr each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.08-1.15 (measured at 60deg.C), and controlling the temperature of the medicinal liquid below 70deg.C;
in practice, herba Lysimachiae Foenumgraeci is preferably decocted in water twice, the first time is 10 times of water, the second time is 8 times of water, each time is extracted for 1.5 hr, the filtrates are combined, the filtrate is concentrated to relative density of 1.10 (measured at 60deg.C), and the temperature of the medicinal liquid is controlled below 65deg.C.
Step 4: decocting radix Stemonae with 8-12 times of water twice for 1-2 hr each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.08-1.15 (measured at 60deg.C), and controlling the temperature of the medicinal liquid below 70deg.C;
in practice, radix Stemonae is decocted in water twice, 10 times of water is added for the first time, 8 times of water is added for the second time, each time of extraction is carried out for 1.5 hours, the filtrates are combined, the relative density of the filtrate is 1.10 (measured at 60 ℃), and the temperature of the liquid medicine is controlled below 65 ℃.
Step 5: mixing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko fine powder as base material, mixing herba Centipedae extract and radix Stemonae extract as binder, granulating in one step, controlling material temperature at 60-70deg.C, and controlling water content at 2% -4%;
in specific implementation, mixed fine powder of radix ranunculi ternati, pseudo-ginseng, rhizoma bletillae, lily and gecko is used as a base material, one-step granulation is carried out, the material temperature is controlled to be 65 ℃, and the water content is controlled to be 3%.
In step 5, the preferred one-step granulation process parameters are set as follows:
air inlet frequency: 25-45HZ;
feed rate: 30-60L/h;
density of extract: 1.08-1.15 (measured at 60 ℃);
atomization pressure: 0.06-0.12MPa;
material temperature: 60-70 ℃.
Bag shaking frequency: 60-120S, 3-5 times
Step 6: sieving with 18-30 mesh sieve, and mixing; the granule is preferably 24 meshes, and the total mixing is preferably 15min.
Step 7: filling the capsule.
When the steps are implemented, all the materials and intermediates after feeding are conveyed to the next working procedure through an air flow or vertical flow by a closed pipeline.
The invention adopts high-temperature instantaneous sterilization and one-step granulation processes to realize continuous manufacture, solves the technical problems of low effective components, high energy consumption, multiple working procedures, heavy dust and low efficiency of the original process, and improves the process and quality level of the product. In addition, the technical problems of the original process and quality of the variety are solved by adopting a high-temperature instantaneous sterilization process and a one-step granulation process, the optimal sterilization process parameters and the optimal one-step granulation process parameters are finally determined, the damage to effective components in the sterilization and preparation processes is avoided, balance points are found in the process and quality, the influence of high temperature and high humidity heat on the effective components is avoided to the greatest extent in the preparation process, the degradation of the effective components is avoided, the content of the effective components is improved, and the technical problems that the effective components of a finished product prepared by adopting the existing granulation technology method are low, the characteristics are changed before and after sterilization, and the effective components in medicinal powder are reduced are solved.
The invention better controls the sterilization method and process, ensures no obvious difference in quality before and after sterilization, and ensures sterilization under the selected process parameters by carrying out detailed study and verification on sterilization parameters, thereby achieving sterilization effect on one hand and no obvious difference in content on the other hand.
In order to further illustrate the invention, the invention will be further described with reference to specific examples of preparation.
Preparation example 1: preparation of extractum
In order to ensure that the prescription of the variety is not changed and the safety and quality controllability of the product are not affected, the prescription and the extraction process are not changed, but the density of the extract is adjusted to ensure the process requirements of the subsequent preparation, and the prescription and the extract are prepared as follows:
prescription: 92g of radix ranunculi ternati, 30g of pseudo-ginseng, 130g of rhizoma bletillae, 40g of lily, 3.4g of gecko, 40g of herba lycopodii and 26g of radix stemonae,
the preparation method of the extract comprises the following steps:
(1) Pulverizing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii, and Gecko into fine powder, and performing high temperature instantaneous sterilization at 135-180deg.C for 5-20 seconds;
(2) Decocting herba Lysimachiae Foenumgraeci with water twice, 10 times of water for the first time and 8 times of water for the second time, extracting for 1.5 hr each time, mixing filtrates, concentrating the filtrate to relative density of 1.10 (60 deg.C), and controlling the temperature of the medicinal liquid below 65deg.C;
(3) Decocting radix Stemonae with water twice, adding 10 times of water for the first time, adding 8 times of water for the second time, extracting for 1.5 hr each time, mixing filtrates, concentrating the filtrate to relative density of 1.10 (measured at 60deg.C), and controlling the temperature of the medicinal liquid below 65deg.C;
preparation example 2:
preparing extract according to the method of preparing 1, mixing fine powder of radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko as base material, mixing herba Centipedae extract and radix Stemonae extract as adhesive, granulating in one step, controlling material temperature at 60-70deg.C, controlling water content at 2% -4%, and granulating in one step with the following parameters:
air inlet frequency: 25-45HZ;
feed rate: 30-60L/h;
density of extract: 1.08-1.15 (measured at 60 ℃);
atomization pressure: 0.06-0.12MPa;
material temperature: 60-70 ℃.
Bag shaking frequency: 60-120S, 3-5 times
After the 24-mesh sieve is sized, the total mixing is carried out for 15min;
the capsule is filled with 0.3 g/granule.
In order to better control the sterilization method and process and ensure no obvious difference in quality before and after sterilization, the screened sterilization process is studied and verified in detail, and the specific research conditions are as follows:
step 1: inspection of the sterilization mode
According to inspection of sterilization modes, although different sterilization modes can meet the requirement of controlling the limit of microorganisms, the characteristics and the content are affected to different degrees, only the high-temperature instantaneous sterilization technology can ensure the appearance characteristics after sterilization, and meanwhile the damage to the effective components of the rhizoma bletillae is minimum, so that the high-temperature instantaneous sterilization is determined to be the sterilization method of the product, the process is studied in detail, and the balance of the process and the quality is finally achieved.
Step 2: high temperature transient sterilization process parameter screening
Orthogonal test factor level design
| Horizontal level | A sterilization temperature (. Degree. C.) | B sterilization time(s) | C particle size (mesh) |
| 1 | 135 | 5 | 50 |
| 2 | 150 | 10 | 80 |
| 3 | 180 | 20 | 100 |
Test results:
orthogonal experimental analysis table
The analysis of variance results are shown below
Analysis of results: from visual analysis, the order of factors affecting the sterilization effect is as follows: a > B > C, analysis of variance results indicate that: the factor A, B, C has no significance on test results, so that the visual analysis of A2B2C3 is taken as the optimal combination of high-temperature instantaneous sterilization, namely the sterilization temperature is 150 ℃, the sterilization time is 10s, and the granularity of the powder is 100 meshes.
Verification test:
three verifications were performed according to the optimal combination sterilization parameters, and 1, 4-di [ 4- (glucosyloxy) benzyl ] -2-isobutyl malate was used as an evaluation index, and the results are shown in the following table.
Verification test result table
Sample 1 detection profile is shown in FIG. 1.
Sample 2 detection profile is shown in figure 2.
Sample 3 the detection profile is shown in figure 3.
From the verification test result, the sterilization process is stable and the quality is controllable.
Step 3: fingerprint comparison
In order to further illustrate the influence of high-temperature instantaneous sterilization on the overall quality before and after sterilization and avoid the limitation of single index component comparison, the comparison is performed by adopting a fingerprint with overall appearance, and the fingerprint is shown in figure 4.
From the aspect of the fingerprint, the fingerprint of 10 batches of samples after sterilization is compared with a reference fingerprint by taking an unsterilized sample as a reference fingerprint, the similarity is larger than 0.9, and the result shows that the whole medicine powder fingerprints before and after sterilization are the same in condition and stable and similar in quality, and the adopted high-temperature instantaneous sterilization process is feasible and cannot influence the product quality.
In order to facilitate the understanding of the present invention, a person skilled in the art will further understand the differences between the present invention and the prior art, and the following description will further explain the preparation process in the prior art and the preparation process of the present invention.
The following is the comparison of the prior art with the content of the intermediate and the finished product of the novel process:
1. comparison of the intermediate content in the prior art and the novel process
2. The content of the finished product of the existing process is compared with that of the finished product of the new process
The result shows that under the condition that the raw materials are the same, different preparation processes have obvious difference on the content, and the finished product prepared by the one-step granulating process is obviously better than the finished product prepared by the wet granulating process in terms of the content of the finished product, which indicates that the one-step granulating process has a protective effect on the chlorophyllin, so that the novel process is superior to the existing process, the content of the sample prepared by the novel process is nearly 1 time of that of the sample prepared by the existing process, and the content is obviously improved, thereby achieving the effect of improving the curative effect.
Meanwhile, the weight difference of products produced by different processes is compared, and the specific table is as follows:
from the difference of the loading, the sample filling is more stable, the particles are even, and the filling process is smoother in the one-step granulating process.
Further, the wet heat sterilization is a traditional sterilization method, is limited to the reason of the wet heat sterilization technology, has long sterilization time, is easy to damage the effective components under the conditions of high humidity and high temperature, is limited to the reason of the detection technology at the time, does not control the effective components, only controls the limit of microorganisms, and causes the current situation that the properties change after sterilization and the effective components of the medicinal powder are reduced.
The wet granulation process is the most commonly used granulation mode in the traditional Chinese medicine preparation, the application is wide, the equipment is simple and easy to obtain, the technical condition is limited in product development, the product is also commercially produced by adopting the wet granulation process, therefore, when the extract is used as an adhesive for granulation, the relative density of the extract is required to be improved, the heating time of the extract is overlong, the temperature is not easy to control during the paste collection, the content of active ingredients is lower, the corresponding product quality requirement is also lower, and therefore, the process is also used all the time, is not researched from the aspect of secondary product development, is optimized and improved, but really has an improvement space in view of the current pharmaceutical level.
Based on the above conditions, the invention provides a brand new preparation method of the lung-benefiting cough-relieving capsule, which optimizes and improves quality and process, and solves the problems existing in the prior art:
the invention finds a balance point in the process and the quality, provides a proper sterilization process for the lung-benefiting and cough-relieving capsules, solves the technical problems of changed characteristics and reduced active ingredients in medicinal powder after sterilization by adopting the existing sterilization technology, and ensures the quality of the sterilized products.
The invention optimizes the granulating process, and through detailed research and verification of the existing granulating process technology, the invention finally determines the optimal one-step granulating method and process parameters by taking the content index of the finished product as the control index, provides a granulating process suitable for the product for the lung-benefiting cough-relieving capsule, solves the technical problems of obvious damage of the target component of the stone chlorophytum after granulating and lower transfer rate of the finished product by adopting the existing wet granulating process, improves the curative effect of the product under the condition of unchanged prescription, and improves the quality of the product.
The original granulating process is wet granulating or tank mixing and swinging granulating, the adopted adhesive is radix stemonae extract and herba lysimachiae extract, but the relative density is above 1.30, the condition of difficult granulating exists, the granule is uneven, the phenomenon of hard granule exists, and the weight difference is not easy to control when the capsule is filled; the one-step granulating method is adopted through the process improvement, so that the problem of difficulty in granulating by adopting the existing wet granulating technology is solved, commercial production is facilitated, meanwhile, the one-step granulating is adopted, the particle uniformity is better, the loading amount is stable during capsule filling, and the control is easy. In addition, the one-step granulating process is closed production, so that the production environment can be improved, and the method is more environment-friendly.
The whole production process realizes sealing and serialization. The dust pollution and labor intensity are reduced, the occupational sanitation protection is enhanced, the production efficiency is improved, and a foundation is laid for intelligent manufacturing.
While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. It is therefore intended that the following claims be interpreted as including the preferred embodiments and all such alterations and modifications as fall within the scope of the invention.
The foregoing description of the preferred embodiment of the invention is not intended to be limiting, but rather to cover all modifications, equivalents, and alternatives falling within the spirit and principles of the invention.
Claims (5)
1. A continuous preparation method of a lung-benefiting cough-relieving capsule is characterized by comprising the following steps: specifically comprises the following steps of,
step 1: weighing seven medicinal materials including radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii, gecko, herba Centipedae and radix Stemonae according to the amount;
step 2: the high-temperature instantaneous sterilization comprises the following specific sterilization steps: pulverizing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko into 50-100 mesh powder, respectively, sterilizing at 135-180deg.C for 5-20 seconds;
step 3: decocting herba Lysionoti Pauciflori with 8-12 times of water twice for 1-2 hr each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.08-1.15 at 60deg.C, and controlling the temperature of the medicinal liquid at 50-70deg.C;
step 4: decocting radix Stemonae with 8-12 times of water twice for 1-2 hr each time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.08-1.15, measuring at 60deg.C, and controlling the temperature of the medicinal liquid at 50-70deg.C;
step 5: mixing radix Ranunculi Ternati, notoginseng radix, rhizoma Bletillae, bulbus Lilii and Gecko fine powder as base material, mixing herba Centipedae extract and radix Stemonae extract as binder, granulating in one step, controlling material temperature at 60-70deg.C, and controlling water content at 2% -4%;
step 6: sieving with 18-30 mesh sieve, and mixing;
step 7: filling the capsules;
after the step 1 is finished, all materials and intermediates in the preparation process are connected by a closed pipeline, and negative pressure or vertical flow is adopted to convey to the next step, so that continuous production is realized;
in the step 5, controlling the temperature of the material to 65 ℃ and controlling the moisture to 3%;
the technological parameters of the one-step granulation are set as follows:
air inlet frequency: 25-45Hz;
feed rate: 30-60L/h;
density of extract: 1.08-1.15, measured at 60 ℃;
atomization pressure: 0.06-0.12MPa;
material temperature: 60-70 ℃;
bag shaking frequency: 60-120S, and 3-5 times.
2. The continuous process for preparing a lung-benefiting and cough-relieving capsule according to claim 1, wherein: in step 3, herba Lysionoti Pauciflori is decocted in water twice, the first time is 10 times of water, the second time is 8 times of water, each time is extracted for 1.5 hours, the filtrates are combined, the filtrate is concentrated to have a relative density of 1.10, measured at 60deg.C, and the temperature of the medicinal liquid is controlled at 55-65deg.C.
3. The continuous process for preparing a lung-benefiting and cough-relieving capsule according to claim 1, wherein: in step 4, radix Stemonae is decocted with water twice, 10 times of water is added for the first time, 8 times of water is added for the second time, each time of extraction is carried out for 1.5 hours, the filtrates are combined, the filtrate is concentrated to have the relative density of 1.10 and measured at 60 ℃, and the temperature of the liquid medicine is controlled at 55-65 ℃.
4. The continuous process for preparing a lung-benefiting and cough-relieving capsule according to claim 1, wherein: during high temperature instant sterilization, the radix ranunculi ternati, the pseudo-ginseng, the rhizoma bletillae, the lily and the gecko are respectively crushed into fine powder, and the fine powder is sieved by a 100-mesh sieve, wherein the sterilization temperature is 150 ℃ and the sterilization time is 10 seconds.
5. The continuous process for preparing a lung-benefiting and cough-relieving capsule according to claim 1, wherein: in step 6, the whole grain screen is 24 meshes, and the capsules are filled after total mixing.
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