Preparation technology of cornstarch plaster dosage form
Through the simplified raw powder plaster preparation process, the problems of the complex process of traditional black plaster and the small loading of modern dosage forms are solved, efficient and low-cost production is achieved, the product loading and safety is improved, and the needs of critically ill patients are met.
Patent Information
- Application Number
- CN202411419448.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-11
- Publication Date
- 2025-02-25
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
The complex process of traditional black plasters makes it difficult to scale and costly; modern dosage form technology is simple, the drug loading volume is small, which makes it difficult to meet the needs of critically ill patients and poses allergic risks.
A preparation process of raw powder paste dosage form is adopted, including raw material preparation, crushing, material mixing, matrix raw and auxiliary material preparation, plaster preparation, packaging and inspection. This process simplifies production steps, reduces operational difficulty and increases drug loading.
The process steps are simplified, production costs and technical requirements are reduced, production cycles are shortened, drug loading is increased, allergic risks are reduced, the needs of critically ill patients are met, and the market competitiveness of the products is enhanced.
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Figure CN119499219A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of raw powder plaster preparation, in particular to a preparation process of a raw powder plaster dosage form. Background Art
[0002] Plaster is a kind of external Chinese medicine, known as thin patch in ancient times. It is made of vegetable oil or animal oil with medicine and boiled into a gelatinous substance, which is applied to one side of cloth, paper or leather. It can be pasted on the affected area for a long time. It is mainly used to treat sores, boils, swelling and pain. Plaster works through the skin. Plaster therapy is one of the commonly used external treatment methods in clinical Chinese medicine. It follows the principles of Chinese medicine syndrome differentiation and treatment and the efficacy, main treatment and meridian of Chinese medicine, fully mobilizes the effectiveness of drugs to coordinate with each other, and forms a compound of multiple drugs to exert the good effect of drugs. Since plasters are directly applied to the body surface, and most of the drugs used to make plasters have a strong smell, and then add strong pungent and fragrant meridian-guiding drugs, they penetrate into the skin, pass through the meridians and internal organs, and play a role in regulating qi and blood, unblocking meridians, dispersing cold and dampness, and relieving swelling and pain.
[0003] For the traditional black plaster dosage forms commonly seen in the market, the brewing process is extremely complicated and cumbersome. This complexity makes it difficult to replicate production and difficult to carry out large-scale production, resulting in high production costs. In the context of increasingly fierce market competition, high costs are not conducive to the widespread promotion of products. At the same time, the complex process places high demands on the technical level of production personnel, increasing the training costs of enterprises and the difficulty of production management. In addition, due to the complex process, the production cycle is often long, which will affect the timeliness of product supply and fail to quickly meet market demand. For modern adhesive plasters, Babu patches and rheumatism patches, although the overall process seems simple and reduces production costs to a certain extent, it is precisely because of the simple process that the space for technological improvement is limited. These dosage forms generally have the problem of small drug loading, which affects the efficacy of the product's application to a certain extent, and it is difficult to meet the needs of some critically ill patients or patients with high efficacy requirements. Although the allergy of these dosage forms is relatively low, there may still be a certain risk of allergies when facing people with special physiques, and the efficacy of the product may also be reduced.
[0004] The traditional black plaster has the following problems in production:
[0005] 1. Complex process and scale-up difficulties: The traditional black plaster preparation process involves multiple steps, from the selection and processing of medicinal materials to the temperature of preparation, time control, and coating process, which all require rich experience and precise operation. This complexity makes it difficult to standardize each link and ensure the consistency of product quality in large-scale production. Therefore, it is difficult to achieve large-scale production, which in turn leads to high production costs and limits its widespread promotion in the market.
[0006] 2. High technical requirements and management challenges: Due to the complexity of the process, the technical level of production personnel is extremely high, which not only requires a lot of time and resources for training, but also increases the difficulty of production management. The difference in technical level of production personnel may lead to unstable product quality, and also increase the cost and pressure of enterprises in human resource management.
[0007] 3. Long production cycle and supply issues: Complex processes usually mean longer production cycles. In today's rapidly changing market demand, long production cycles may lead to untimely product supply and failure to meet consumer demand. This will not only affect the company's market share, but may also reduce consumer trust in the product.
[0008] Plasters such as adhesive plasters, Babu patches, and rheumatism patches have the following problems during production:
[0009] 1. Simple process and technical limitations: Although the process of these modern dosage forms of plasters is relatively simple and reduces production costs, it also limits the space for technological improvement. Simple processes are difficult to achieve major technological breakthroughs, and cannot make greater improvements in efficacy and consolidation, and it is difficult to meet consumers' demand for high-quality products.
[0010] 2. Small drug loading and insufficient efficacy: This type of dosage form generally has a small drug loading, which is often unsatisfactory for some seriously ill patients or patients with high efficacy requirements. When treating certain diseases, it may not provide sufficient drug dosage, thus affecting the treatment effect and reducing the practicality and market competitiveness of the product.
[0011] 3. Allergy risk and special populations: Although the allergy of these dosage forms is relatively low, there may still be a certain allergy risk when facing people with special physical constitutions. This is because everyone's physical constitution is different, and the reaction to drugs and materials is also different. Even for low-allergenic products, the possibility of allergic reactions in people with special physical constitutions cannot be completely ruled out. At the same time, the existence of allergy risks may also reduce the efficacy of the product, because allergic reactions may affect the absorption and action of the drug. For this reason, a preparation process for a cornstarch plaster dosage form is proposed. Summary of the invention
[0012] The object of the present invention is to provide a preparation process of a raw powder plaster dosage form to solve the problems raised in the above background technology.
[0013] To achieve the above object, the present invention provides the following technical solution: a preparation process of a raw powder plaster dosage form, comprising the following steps:
[0014] S1. Preparation of raw materials for raw powder plaster;
[0015] S2. The raw materials of the raw powder plaster are crushed by a crusher;
[0016] S3, the materials are mixed and set aside for use;
[0017] S4. Preparation of raw materials for base materials and auxiliary materials for raw powder plasters;
[0018] S5, plaster preparation;
[0019] S6, packaging, inspection and warehousing.
[0020] Preferably, in the above: in S1, the raw materials of the raw powder plaster include asarum, atractylodes, notoginseng, myrrh, safflower, ligusticum chuanxiong, clematis, salvia miltiorrhiza, corydalis, lycopodiella cuneata and cibotium barometz.
[0021] Preferably, the composition weight of the raw materials of the raw powder plaster is:
[0022] Asarum: 75-85g;
[0023] Atractylodes lancea: 65-75g;
[0024] Panax notoginseng: 45-55g;
[0025] Myrrh: 75-85g;
[0026] Safflower: 45-55g;
[0027] Rhizoma Chuanxiong: 110-130g;
[0028] Clematis: 115-135g;
[0029] Salvia miltiorrhiza: 70-85g;
[0030] Corydalis yanhusuo: 146-153g;
[0031] Stretching grass: 95-105g;
[0032] Cibotium barometz: 98-102g.
[0033] Preferably, in the above: in S2, the pulverizing of the raw material of the raw powder plaster comprises the following sub-steps:
[0034] S201, firstly crush the dried Asarum, Atractylodes and Panax notoginseng separately;
[0035] S202, drying myrrh, safflower, chuanxiong, clematis, salvia miltiorrhiza, corydalis, lycopodiella cuneata and cibotium barometz at low temperature and then crushing them, wherein the low temperature drying temperature is 55-65° C.;
[0036] S203, using a 100-mesh sieve to screen the crushed Chinese medicinal materials.
[0037] Preferably, in the above-mentioned step S3, the materials are mixed and set aside as material A.
[0038] Preferably, in the above: in S4, the raw materials of the matrix and auxiliary materials include honey, lanolin, azone, glycerin, borneol, camphor and sodium benzoate;
[0039] The raw materials of the raw materials are as follows according to the mass ratio:
[0040] Honey: 38-42%;
[0041] Lanolin: 35-45%;
[0042] Azone: 4-6%;
[0043] Glycerol: 2-4%;
[0044] Borneol: 2-4%;
[0045] Camphor: 2.5-3.5%;
[0046] Sodium benzoate: 1.8-2.2%.
[0047] Preferably, in the above step S5, the preparation of the plaster comprises the following sub-steps:
[0048] S501, selecting a plaster storage container;
[0049] S502, placing honey in a container, heating and boiling over a slow fire, and stirring continuously, so that the honey can drip into beads;
[0050] S503, placing lanolin in a container, and heating it over a low fire until it melts into a transparent liquid;
[0051] S504, mixing azone and glycerol and stirring evenly;
[0052] S505, stirring and mixing borneol and 75% ethanol evenly;
[0053] S506, stirring and mixing camphor and 75% ethanol;
[0054] S507, mixing the honey in S502, the lanolin in S503, the azone in S504 and the glycerol together for use as material B;
[0055] S508, mixing the borneol and ethanol mixture in S505 and the camphor and ethanol mixture in S506 together and stirring them for use as material C;
[0056] S509, using a mixer to mix material A with material B, and then adding material C and sodium benzoate for secondary mixing;
[0057] S510, preparing a mixed paste for standby use, wherein the paste is yellowish brown or dark brown, has a fresh fragrance, and is sticky and tough;
[0058] S511, adding the paste into a molding machine, and using the molding machine to make the paste into tablets, wherein the formed plaster tablets are smooth, delicate, and oily in color, and slightly elastic;
[0059] S512, placing the formed plaster tablet into a medical non-woven fabric fixing dressing of required specifications using an automated conveying device or manually, thereby completing the preparation of the raw powder plaster.
[0060] Preferably, in the above step: in S502, the boiling time is 1.5-2.5 hours.
[0061] Preferably, in the above-mentioned step S503, the heating time is 25-35 minutes.
[0062] Preferably, in S509, the mixing and stirring time of material A and material B is 18-22 minutes, and the secondary mixing and stirring time is 25-35 minutes.
[0063] Compared with the prior art, the present invention adopts the above technical solution and has the following technical effects:
[0064] 1. The present invention prepares cornstarch plaster dosage forms according to raw materials and carriers of different formulas required for plasters. Compared with the complicated boiling process of traditional black plasters, the cornstarch plaster production process greatly simplifies the production steps and reduces the difficulty of operation. The plaster is formed and processed according to the correct matrix ratio and production process of the cornstarch plaster, which can better reflect the significant effects of the oiliness, viscosity, permeability and other properties of the formed cornstarch plaster, but does not cause the influence and limitation of the efficacy of the plaster product due to its process technology.
[0065] Second, the present invention simplifies the process steps, making it easier to replicate and mass produce, reducing production costs. At the same time, it also reduces the technical level requirements for production personnel, facilitates production management, shortens the production cycle, and ensures the timeliness of product supply.
[0066] 3. The present invention increases the drug loading capacity of the plaster dosage form, making the product more practical for critically ill patients and patients with higher requirements for efficacy, can better meet the needs of different patients, and enhances the market competitiveness of the product.
[0067] 4. The present invention adopts special materials and formulas, which effectively reduce the risk of allergies, expand the scope of applicable population of the product, and improve the safety and reliability of the product. It combines the efficacy and drug loading advantages of traditional herbal medicines with the comfort, ease of operation and low cost of modern dosage forms. It not only retains the profoundness of traditional Chinese medicine, exerts the good therapeutic effects of traditional herbal medicines, but also has the convenience and practicality of modern dosage forms, providing patients with better treatment options. BRIEF DESCRIPTION OF THE DRAWINGS
[0068] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.
[0069] Figure 1 It is a process flow chart of the present invention. DETAILED DESCRIPTION
[0070] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0071] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the effects and purposes that can be achieved by this application.
[0072] Example
[0073] See also Figure 1 The present invention provides a technical solution: a preparation process of a raw powder paste dosage form, comprising the following steps:
[0074] S1. Preparation of raw materials for raw powder plaster;
[0075] Raw materials for raw powder plasters include asarum, atractylodes, notoginseng, myrrh, safflower, chuanxiong, clematis, salvia miltiorrhiza, corydalis, lycopodiella cuneata and cibotium barometz;
[0076] The composition weight of the raw materials of the raw powder plaster is:
[0077] Asarum: 80g; Atractylodes: 70g; Panax notoginseng: 50g; Myrrh: 80g; Carthamus: 50g; Ligusticum chuanxiong: 120g; Clematidis: 120g; Salvia miltiorrhiza: 80g; Corydalis: 150g; Lycopodiella ciliata: 100g; Cibotium barometz: 100g, a total of 1kg.
[0078] S2. The raw materials of the raw powder plaster are crushed by a crusher;
[0079] The crushing of raw materials for raw powder plasters includes the following sub-steps:
[0080] S201, firstly crush the dried Asarum, Atractylodes, and Panax notoginseng separately, and use a crusher to crush them twice continuously;
[0081] S202, drying myrrh, safflower, chuanxiong, clematis, salvia miltiorrhiza, corydalis, lycopodiella cuneata and cibotium barometz at low temperature and then crushing them, wherein the low temperature drying temperature is 60° C.;
[0082] S203, using a 100-mesh sieve to screen the crushed Chinese medicinal materials.
[0083] S3, the materials are mixed and set aside for use; the materials are mixed and set aside for use as material A.
[0084] S4. Preparation of raw materials for base materials and auxiliary materials for raw powder plasters;
[0085] The raw materials of matrix and auxiliary materials include honey, lanolin, azone, glycerin, borneol, camphor and sodium benzoate;
[0086] The raw materials and auxiliary materials are in the following mass proportions: honey: 40%; lanolin: 30%; azone: 5%; glycerol: 3%; borneol: 3%; camphor: 3%; sodium benzoate: 2% and appropriate amount of 75% ethanol.
[0087] S5, plaster preparation;
[0088] The preparation of the plaster includes the following sub-steps:
[0089] S501, selecting a plaster storage container, the container is used to store raw materials of raw materials and auxiliary materials respectively;
[0090] S502, placing the honey in a container, heating it over a slow fire and stirring it constantly, so that the honey can drip into beads; the boiling time is 2 hours.
[0091] S503. Place lanolin in a container and heat over low heat until it melts into a transparent liquid; the heating time is 30 minutes.
[0092] S504, mixing azone and glycerol and stirring evenly;
[0093] S505, stirring and mixing borneol and 75% ethanol evenly;
[0094] S506, stirring and mixing camphor and 75% ethanol;
[0095] S507, mixing the honey in S502, the lanolin in S503, the azone in S504 and the glycerol together for use as material B;
[0096] S508, mixing the borneol and ethanol mixture in S505 and the camphor and ethanol mixture in S506 together and stirring them for use as material C;
[0097] S509, using a mixer to mix material A with material B first, and then adding material C and sodium benzoate for secondary mixing and stirring; the mixing time of material A and material B is 20 minutes, and the secondary mixing and stirring time is 30 minutes.
[0098] S510, prepare the mixed paste for standby use, the paste is yellow-brown or dark brown, has a fresh fragrance, is sticky and tough, and the stirring is stopped after the raw powder plaster is prepared. Take out all the mixed pastes, place them in a container for standby use, and wait for the next molding and tableting process;
[0099] S511, adding the paste into a molding machine, and using the molding machine to make the paste into tablets, wherein the formed plaster tablets are smooth, delicate, oily, and slightly elastic;
[0100] S512, placing the formed plaster tablet into a medical non-woven fabric fixing dressing of required specifications using an automated conveying device or manually, thereby completing the preparation of the raw powder plaster.
[0101] S6, packaging, inspection, warehousing, selection of appropriate packaging materials, and ensuring aseptic operation.
[0102] In summary, the present invention prepares the raw powder plaster dosage form according to the raw materials and carriers of different formulas required for the plaster. Compared with the complicated boiling process of the traditional black plaster, the raw powder plaster production process greatly simplifies the production steps and reduces the difficulty of operation. The plaster is processed according to the correct matrix ratio and production process of the raw powder plaster, which can better reflect the significant effects of the oiliness, viscosity, permeability and other properties of the raw powder plaster, but does not cause the influence and limitation of the process technology on the efficacy of the plaster product;
[0103] The present invention simplifies the process steps, making it easier to replicate and mass produce, and reducing production costs. At the same time, it also reduces the technical level requirements for production personnel, facilitates production management, shortens the production cycle, and ensures the timeliness of product supply;
[0104] The present invention increases the drug loading of the plaster dosage form. This makes the product more practical for patients with severe illnesses and patients with higher requirements for efficacy, can better meet the needs of different patients, and improves the market competitiveness of the product;
[0105] The present invention adopts special materials and formulas, which effectively reduces the risk of allergies, expands the applicable population range of the product, and improves the safety and reliability of the product;
[0106] The present invention combines the efficacy and drug loading advantages of traditional herbal medicines with the comfort, ease of operation and low cost of modern dosage forms. It not only retains the profoundness of traditional Chinese medicine and exerts the good therapeutic effects of traditional herbal medicines, but also has the convenience and practicality of modern dosage forms, providing patients with better treatment options.
[0107] It will be appreciated by those skilled in the art that the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways, even if such combinations and / or combinations are not explicitly described in the present invention. In particular, the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways without departing from the spirit and teachings of the present invention. All of these combinations and / or combinations fall within the scope of the present invention.
Claims
1. A preparation process of a raw powder paste dosage form, characterized in that: The following steps are involved: S1. Preparation of raw materials for raw powder plaster; S2. The raw materials of the raw powder plaster are crushed by a crusher; S3, the materials are mixed and set aside for use; S4. Preparation of raw materials for base materials and auxiliary materials for raw powder plasters; S5, plaster preparation; S6, packaging, inspection and warehousing.
2. The preparation process of a raw powder plaster dosage form according to claim 1, characterized in that: In S1, the raw materials of the raw powder plaster include asarum, atractylodes, Panax notoginseng, myrrh, safflower, ligusticum chuanxiong, clematis, salvia miltiorrhiza, Corydalis yanhusuo, lycopodiella cuneata and Cibotium barometz.
3. The preparation process of a raw powder plaster dosage form according to claim 2, characterized in that: The composition weight of the raw material of the raw powder plaster is: Asarum: 75-85g; Atractylodes lancea: 65-75g; Panax notoginseng: 45-55g; Myrrh: 75-85g; Safflower: 45-55g; Rhizoma Chuanxiong: 110-130g; Clematis: 115-135g; Salvia miltiorrhiza: 70-85g; Corydalis yanhusuo: 146-153g; Stretching grass: 95-105g; Cibotium barometz: 98-102g.
4. The preparation process of a raw powder plaster dosage form according to claim 3, characterized in that: In S2, the pulverization of the raw material of the raw powder plaster comprises the following sub-steps: S201, firstly crush the dried Asarum, Atractylodes and Panax notoginseng separately; S202, drying myrrh, safflower, chuanxiong, clematis, salvia miltiorrhiza, corydalis, lycopodiella cuneata and cibotium barometz at low temperature and then crushing them, wherein the low temperature drying temperature is 55-65° C.; S203, using a 100-mesh sieve to screen the crushed Chinese medicinal materials.
5. The preparation process of a raw powder plaster dosage form according to claim 3, characterized in that: In S3, the materials are mixed and prepared as material A.
6. The preparation process of a raw powder plaster dosage form according to claim 5, characterized in that: In S4, the matrix raw materials and auxiliary materials include honey, lanolin, azone, glycerin, borneol, camphor and sodium benzoate; The raw materials of the raw materials are as follows according to the mass ratio: Honey: 38-42%; Lanolin: 35-45%; Azone: 4-6%; Glycerol: 2-4%; Borneol: 2-4%; Camphor: 2.5-3.5%; Sodium benzoate: 1.8-2.2%.
7. The preparation process of a raw powder plaster dosage form according to claim 6, characterized in that: In S5, the plaster preparation includes the following sub-steps: S501, selecting a plaster storage container; S502, placing honey in a container, heating and boiling over a slow fire, and stirring continuously, so that the honey can drip into beads; S503, placing lanolin in a container, and heating it over a low fire until it melts into a transparent liquid; S504, mixing azone and glycerol and stirring evenly; S505, stirring and mixing borneol and 75% ethanol evenly; S506, stirring and mixing camphor and 75% ethanol; S507, mixing the honey in S502, the lanolin in S503, the azone in S504 and the glycerol together for use as material B; S508, mixing the borneol and ethanol mixture in S505 and the camphor and ethanol mixture in S506 together and stirring them for use as material C; S509, using a mixer to mix material A with material B, and then adding material C and sodium benzoate for secondary mixing; S510, preparing a mixed paste for standby use, wherein the paste is yellowish brown or dark brown, has a fresh fragrance, and is sticky and tough; S511, adding the paste into a molding machine, and using the molding machine to make the paste into tablets, wherein the formed plaster tablets are smooth, delicate, and oily in color, and slightly elastic; S512, placing the formed plaster tablet into a medical non-woven fabric fixing dressing of required specifications using an automated conveying device or manually, thereby completing the preparation of the raw powder plaster.
8. The preparation process of a raw powder plaster dosage form according to claim 7, characterized in that: In S502, the boiling time is 1.5-2.5 hours.
9. The preparation process of a raw powder plaster dosage form according to claim 7, characterized in that: In S503, the heating time is 25-35 minutes.
10. The preparation process of a raw powder plaster dosage form according to claim 7, characterized in that: In S509, the mixing and stirring time of material A and material B is 18-22 minutes, and the secondary mixing and stirring time is 25-35 minutes.