Ant-radix scrophulariae-radix ginseng arthralgia-relieving pill for treating rheumatic arthralgia and preparation process thereof
Through the specific raw material ratio and precise preparation process of Ant Shuangzantongbi Pills, the problems of poor effect and unstable quality of traditional Chinese medicine compound preparations in the treatment of rheumatism and numbness were solved, and the goals of efficient treatment and industrial production were achieved.
Patent Information
- Application Number
- CN202510729249.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-03
- Publication Date
- 2025-07-11
AI Technical Summary
In the treatment of rheumatism, the existing traditional Chinese medicine compound preparations have unreasonable raw material ratios and inaccurate preparation processes, resulting in poor treatment effects and unstable quality, making it difficult to meet the needs of industrial production.
The specific ratio of 10 medicinal materials such as ants, red ginseng, and black-snake snakes is adopted, and the detailed wine-roasted process and precise preparation process steps are adopted, including clean selection, crushing, mixing, sterilization, etc., to ensure the stability of the drug quality and efficacy.
It significantly improves the effect of the drug in treating rheumatism, with the reduction rates of joint pain and swelling reaching 92% and 88% respectively, and ensures the quality stability and repeatability of the drug, making it suitable for industrial production.
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Figure CN120285111A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly to an ant double ginseng arthralgia-relieving pill for treating rheumatic arthralgia and its preparation process. Background Art
[0002] Rheumatic arthralgia is a common chronic disease, and its main symptoms include joint pain, swelling, numbness, and limited mobility, etc., which seriously affect the quality of life of patients. At present, there are various drugs for treating rheumatic arthralgia on the market, including chemically synthesized drugs, traditional Chinese medicine compound preparations, etc. Although chemically synthesized drugs may have certain anti-inflammatory and analgesic effects in the short term, long-term use is often accompanied by more side effects, such as gastrointestinal reactions, liver and kidney function damage, etc. Traditional Chinese medicine compound preparations are favored by more and more patients because of their characteristics of overall conditioning and relatively small side effects. However, there are differences in the raw material ratio and preparation process of existing traditional Chinese medicine compound preparations, and some products need to be improved in terms of treatment effect, extraction rate of active ingredients, and quality stability. In terms of the raw material ratio, most of the existing technologies lack in-depth research on the combination and dosage of medicinal materials, and it is difficult to give full play to the synergistic effect between various medicinal materials, resulting in an unsatisfactory effect of the drug in treating rheumatic arthralgia. In the preparation process, the traditional medicinal material processing methods and production processes cannot accurately control the dissolution and retention of the active ingredients of the drug, which not only affects the medicinal effect, but also may lead to unstable quality of products in different batches, and it is difficult to meet the requirements of industrial large-scale production. Compared with the ant double ginseng arthralgia-relieving pill and its preparation process of the present invention with unique raw material ratio, optimized medicinal material treatment, and precise preparation process, the existing technologies have obvious deficiencies in improving the medicinal effect of the drug, ensuring quality stability, and realizing industrial production. Therefore, an ant double ginseng arthralgia-relieving pill for treating rheumatic arthralgia and its preparation process are proposed. Summary of the Invention
[0003] In order to overcome the above-mentioned defects of the prior art, the embodiments of the present invention provide an ant double ginseng arthralgia-relieving pill for treating rheumatic arthralgia and its preparation process, which solves the problems that the existing drugs for rheumatic arthralgia have suboptimal ratios and poor processes, affecting the curative effect and production.
[0004] To achieve the above object, the present invention provides the following technical solutions: An ant double ginseng arthralgia-relieving pill for treating rheumatic arthralgia and its preparation process are made from the following raw materials: ants, red ginseng, stir-fried with wine black snake, salvia miltiorrhiza, millettia reticulata, coix seed, speranskia tuberculata, paulownia bark, angelica sinensis, phellodendron amurense, stir-fried atractylodes lancea, alisma orientale, cassia twig, lycopodium clavatum, centipede, and the auxiliary material is honey; The raw materials are in the following weight ratios: 375 g of ants, 22.5 g of red ginseng, 3.75 g of wine-fried zaocys dhumnade, 45 g of salvia miltiorrhiza, 45 g of spatholobus suberectus, 45 g of coix seed, 37.5 g of herba speranskiae tuberculatae, 37.5 g of cortex iliicis, 37.5 g of angelica sinensis, 30 g of phellodendron amurense, 30 g of stir-fried atractylodes lancea, 15 g of alisma orientale, 15 g of cassia twig, 7.5 g of herba lycopodii, 3.75 g of scolopendra, with a total of 750 g; Verified by clinical trials, for the pills prepared according to this ratio, when treating patients with rheumatic arthralgia, after 30 days, the effective rate of joint pain relief reaches 92%, and the effective rate of swelling subsidence reaches 88%, significantly higher than the average pain relief rate of 75% and the swelling subsidence rate of 70% of existing similar drugs.
[0005] Preferably, the preparation method of the wine-fried zaocys dhumnade is as follows: Remove the head and scales of the zaocys dhumnade, break it into sections of one inch, mix it evenly according to the ratio of zaocys dhumnade to yellow rice wine of 100∶20, and moisten it for more than 12 hours; Through the operating equipment, set the rotation speed at 15 revolutions and the temperature at 225 °C. After the equipment warms up, put the well-moistened zaocys dhumnade into the pan and stir-fry. Keep the frying temperature at 225 °C ± 10 °C for about 25 minutes until the surface is brownish-black and the snake meat is light brownish-yellow to yellowish-brown, hard and with the smell of wine, then take it out and let it cool.
[0006] Preferably, a preparation process of the ant double-ginseng arthralgia-relieving pill for treating rheumatic arthralgia includes the following steps: S1: Pretreatment: Prepare the materials, carry out the cleaning and selection of the medicinal materials and cut pieces. The cleaning and selection adopt manual and vibration screening with a frequency of 50 - 70 times per minute to process the materials that need to be cleaned; Clean and dry the salvia miltiorrhiza; Wine-fry the zaocys dhumnade according to the method described in claim 2; Control the content of medicinal residues and impurities in the medicinal materials after cleaning and selection within 1.5%; S2: Crushing and material receiving: Receive the qualified materials and complete the recheck; S3: Crushing and mixing: Mix 15 raw materials; S4: Crushing: Operate the ultrafine pulverizer to crush the materials, crush the mixed materials. After the crushing is completed, pack the medicinal powder into double-layer packaging, complete the sealing, weighing, and labeling; Check the integrity of the sieve before and after crushing; S5: Post-treatment: Transfer the medicinal powder to the temporary storage room, take samples for inspection, and handle the warehousing after sterilization by cobalt-60 irradiation.
[0007] Preferably, in the step S1, the 15 kinds of cleaned medicinal materials and cut pieces obtained by pretreatment should be free of insect pests, mildew, and other contaminants, and the content of medicinal residues and impurities should not exceed 2.0%.
[0008] Preferably, in the step S1, during the moistening process of the zaocys dhumnade, turn it over every 2 - 3 hours to ensure uniform moistening.
[0009] Preferably, in step S1, the selection of medicinal materials is carried out by combining manual selection and vibration screening, and the vibration screening frequency is 50 - 70 times per minute.
[0010] Preferably, in step S4, the environmental temperature for packaging the medicinal powder is controlled at 20 - 25 °C, and the relative humidity is 45% - 65%.
[0011] Preferably, in step S5, the post - treatment is carried out by cobalt - 60 irradiation sterilization, and the irradiation dose is 8 - 12 kGy.
[0012] Preferably, the honey is medium - grade honey refined at 100 - 110 °C for 15 - 25 minutes.
[0013] Preferably, in step S3, a three - dimensional motion mixer is used for pulverizing and mixing, the mixing time is 30 - 45 minutes, and the rotation speed is 10 - 15 revolutions per minute.
[0014] The technical effects and advantages of an ant double - ginseng pain - relieving pill for treating rheumatoid arthralgia and its preparation process of the present invention: 1. In this invention, with specific raw material ratios, the medicinal materials act synergistically with each other, significantly enhancing the effect of the drug in treating rheumatoid arthralgia. Through scientific compatibility, this formula can more effectively exert the effects of expelling wind and removing dampness, dredging collaterals and relieving pain, directly targeting the etiology and pathogenesis of rheumatoid arthralgia, and bringing better treatment effects to patients.
[0015] 2. In this invention, the detailed limitation of the wine - frying process of Zaocys dhumnades effectively improves the dissolution rate of the active ingredients of the drug. Through the optimized wine - frying process, the medicinal value of Zaocys dhumnades can be fully stimulated, enabling the drug to better exert the effects of expelling wind and dredging collaterals, removing dampness and relieving pain, enhancing the therapeutic effect of the drug from the root, and improving the clinical efficacy of the drug.
[0016] 3. In this invention, the complete and precise preparation process steps, from raw material pretreatment to finished product warehousing, have set strict operation specifications and parameter controls for each link, effectively ensuring the stability and uniformity of drug quality. Whether it is the control of the uniformity of material mixing, the requirement for the fineness of the medicinal powder by ultrafine pulverization, or the control of the loss rate of active ingredients by the sterilization method, it ensures the safety and effectiveness of the drug, providing patients with drugs of reliable quality.
[0017] 4. In this invention, the preparation process has strong repeatability. Under different parameter adjustments, it can stably produce ant double - ginseng pain - relieving pills with qualified quality and good curative effects. This characteristic is convenient for industrial production, can provide reliable technical guarantees for large - scale production, reduce the uncertainty in the production process, and is conducive to the large - scale promotion and application of the product.
[0018] 5. The invention demonstrates obvious scientificity and superiority. After changing the raw material ratio or preparation process, problems such as the decline in the therapeutic effect of the drug and the large loss of active ingredients are prominent, which further proves the significant advantages of the technical solution of the present invention in the treatment of rheumatism and arthralgia, as well as its value in practical applications. Brief Description of the Drawings
[0019] Figure 1 It is the process flow chart in the preparation process of an ant double ginseng pain-relieving pill for treating rheumatism and arthralgia and its preparation process proposed by the present invention. Detailed Embodiments
[0020] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts belong to the scope of protection of the present invention. It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. Without further limitations, the elements defined by the statement "including..." do not exclude the existence of additional identical elements in the process, method, article or device including the said elements. Embodiment
[0021] Reference Figure 1 , this embodiment provides an ant double ginseng pain-relieving pill for treating rheumatism and arthralgia and its preparation process, which is used for the implementation of the preparation of ant double ginseng pain-relieving pill under standard ratio and conventional parameters. The specific implementation content includes: Raw material preparation: Accurately weigh the raw materials: 375 g of ants, 22.5 g of red ginseng, 3.75 g of zaocys dhumnades, 45 g of salvia miltiorrhiza, 45 g of spatholobus suberectus, 45 g of coix lacryma-jobi, 37.5 g of herba speranskiae tuberculatae, 37.5 g of cortex eriobotryae, 37.5 g of angelica sinensis, 30 g of phellodendron amurense, 30 g of stir-fried atractylodes lancea, 15 g of alisma orientale, 15 g of cinnamon twig, 7.5 g of lycopodium clavatum, 3.75 g of scolopendra, and the auxiliary material is medium honey refined at 105 °C for 20 minutes.
[0022] Implementation steps: S1: Pretreatment: Prepare materials, perform cleaning and selection on medicinal materials and cut pieces. Manual and vibration screening are used for cleaning and selection, with a frequency of 50 - 70 times per minute, and materials that need to be washed are processed; Wash and dry Salvia miltiorrhiza; Stir-frying Wusha Snake with Wine: Remove the head and scales of Wusha Snake, break it into sections, put it into a ceramic vat, add yellow rice wine according to the ratio of Wusha Snake ∶ yellow rice wine = 100 ∶ 20, stir evenly, and moisten it for 12 hours, turning it over every 3 hours during this period. Start the DCCY - 900 electromagnetic medicine stir-frying machine, set the rotation speed to 15 revolutions, the temperature to 225 °C, pour in the moistened Wusha Snake after heating up, stir-fry, keep the temperature at 225 °C ± 10 °C, stir-fry for about 25 minutes until the surface is brown to black, the snake meat is light brownish-yellow to yellowish-brown, hard with the smell of wine, pour it out and let it cool, weigh and label it, notify QA to take samples for inspection, and store it in the warehouse after passing the inspection; S2: Crushing and Material Receiving, strictly implement the material receiving procedure for the pretreated medicinal materials, double-check the name, specification, batch number, and quantity by two people, and QA monitors the whole process; S3: Crushing and Mixing, put 15 kinds of materials into a three-dimensional motion mixer, set the rotation speed to 12 revolutions per minute, and mix for 40 minutes. Regularly check the operation of the equipment during mixing, take samples for detection after mixing, and the coefficient of variation (CV value) of the material mixing uniformity is 2.5%, meeting the standard of not exceeding 3%; S4: Crushing: Use the DBLJ - 40 - 37 ultrafine crusher installed with a 100-mesh sieve. Check the equipment before crushing, and slowly feed the mixed materials for crushing. Under a clean environment with a temperature of 22 °C and a relative humidity of 55%, put the medicinal powder into double-layer packaging (inner bag: polyethylene clean bag, outer bag: woven bag), seal, weigh, and label. Check the integrity of the sieve before and after crushing. After the production is completed, after detection, the passing rate of the medicinal powder through the No. 5 sieve is 100%, and the passing rate through the No. 6 sieve is 96%; S5: Post-treatment: Transfer the medicinal powder to the medicinal powder temporary storage room that has been disinfected by ultraviolet rays for 30 minutes, sterilize it by cobalt-60 irradiation, set the dose to 10 kGy, and monitor the parameters of the sterilization process. After passing the inspection after sterilization, handle the warehousing procedures.
[0023] Implementation Effect: Select 100 patients with rheumatoid arthralgia, randomly divide them into a treatment group and a control group, with 50 cases in each group. The treatment group takes the pills prepared in this example, 3 times a day, 6 g each time; the control group takes a similar best-selling drug on the market according to the dosage in the instruction manual. After evaluating after a 30-day course of treatment, the effective rate of relieving joint pain in the treatment group is 93%, the effective rate of swelling subsidence is 89%, and the symptoms such as limb numbness and limited movement are significantly improved; the effective rate of relieving joint pain in the control group is 75%, and the effective rate of swelling subsidence is 70%. Detect the stir-fried Wusha Snake with wine, and the dissolution rate of its active ingredients is increased by 32% compared with the traditional process. Example
[0024] Reference Figure 1, this embodiment provides an ant double ginseng arthralgia pill for treating rheumatism and its preparation process, which is used for the implementation of the preparation of the ant double ginseng arthralgia pill under adjusted parameters. The specific implementation content includes: Raw material preparation: Accurately weigh the raw materials: 375 g of ants, 22.5 g of red ginseng, 3.75 g of zaocys dhumnades, 45 g of salvia miltiorrhiza, 45 g of spatholobus suberectus, 45 g of coix lacryma-jobi, 37.5 g of speranskia tuberculata, 37.5 g of ilicium verum, 37.5 g of angelica sinensis, 30 g of phellodendron amurense, 30 g of stir-fried atractylodes lancea, 15 g of alisma orientale, 15 g of cinnamon twig, 7.5 g of lycopodium clavatum, 3.75 g of scolopendra. The auxiliary material is medium honey refined at 100 °C for 25 minutes.
[0025] Implementation steps: S1: Pretreatment: Prepare materials, carry out cleaning and selection on the medicinal materials and cut pieces. The cleaning and selection adopt manual and vibration screening with a frequency of 50 - 70 times per minute, and the materials that need to be cleaned are processed; clean and dry the salvia miltiorrhiza; Stir-fry zaocys dhumnades with wine: Remove the head and scales of zaocys dhumnades and break it into sections. Put it into a ceramic vat, add yellow rice wine according to the ratio of zaocys dhumnades∶yellow rice wine = 100∶20, stir evenly and then moisten it for 12 hours, turning it over every 3 hours during this period. Start the DCCY-900 electromagnetic medicine stir-frying machine, set the rotation speed at 15 revolutions, the temperature at 225 °C. After heating up, pour in the moistened zaocys dhumnades and stir-fry, keep the temperature at 225 °C ± 10 °C, stir-fry for about 25 minutes until the surface is brown to black, the snake meat is light brownish yellow to yellowish brown, hard with the smell of wine, pour it out and let it cool, weigh and label it, notify QA to take samples for inspection, and store it in the warehouse after passing the inspection; S2: Crushing and material receiving, strictly implement the material receiving procedure for the pretreated medicinal materials, double-check the product name, specification, batch number, and quantity by two people, and QA monitors the whole process; S3: Crushing and mixing, put 15 kinds of materials into a three-dimensional motion mixer, set the rotation speed at 10 revolutions per minute, and mix for 45 minutes. Regularly check the operation of the equipment during mixing, take samples for detection after mixing, and the coefficient of variation (CV value) of the material mixing uniformity meets the standard of not exceeding 3%; S4: Crushing: Use the DBLJ-40-37 ultrafine crusher equipped with a 100-mesh sieve. Check the equipment before crushing, and slowly feed the mixed materials for crushing. Under the clean environment with a temperature of 20 °C and a relative humidity of 45%, put the medicinal powder into double-layer packaging, seal, weigh, and label it. Check the integrity of the sieve before and after crushing. After the production is completed, after detection, the passing rate of the medicinal powder through the No. 5 sieve is 100%, and the passing rate through the No. 6 sieve is 96%; S5: Post-treatment: Transfer the medicinal powder to the medicinal powder temporary storage room disinfected by ultraviolet rays for 30 minutes, irradiate and sterilize it with cobalt-60, set the dose at 8 kGy, and monitor the sterilization process parameters. After passing the inspection after sterilization, handle the warehousing procedures.
[0026] Implementation effect: 100 patients with rheumatoid arthralgia were selected. The grouping and administration method were the same as those in Example 1. After one treatment course, the effective rate of relieving joint pain in the treatment group was 91%, and the effective rate of subsiding swelling was 87%. After detecting the wine-fried Zaocys dhumnades, the dissolution rate of its active ingredients was increased by 30% compared with the traditional wine-frying process. Example
[0027] Reference Figure 1 , this example provides an ant double ginseng arthralgia-relieving pill for treating rheumatoid arthralgia and its preparation process, which is used for the implementation of preparing the ant double ginseng arthralgia-relieving pill under another set of adjusted parameters. The specific implementation content includes: Raw material preparation: Accurately weigh the raw materials: 375 g of ants, 22.5 g of red ginseng, 3.75 g of Zaocys dhumnades, 45 g of Salvia miltiorrhiza, 45 g of Caulis Spatholobi, 45 g of Coix lacryma-jobi, 37.5 g of Herba Speranskiae tuberculatae, 37.5 g of Cortex Firmianae, 37.5 g of Angelica sinensis, 30 g of Phellodendron amurense, 30 g of stir-fried Atractylodes lancea, 15 g of Alisma orientale, 15 g of Ramulus Cinnamomi, 7.5 g of Herba Lycopodii, 3.75 g of Scolopendra subspinipes. The auxiliary material is medium honey refined at 110 °C for 15 minutes.
[0028] Implementation steps: S1: Pretreatment: Prepare materials, carry out cleaning and selection on the medicinal materials and cut crude drugs. The cleaning and selection adopt manual and vibration screening with a frequency of 50 - 70 times per minute, and process the materials that need to be cleaned; clean and air-dry Salvia miltiorrhiza; Wine-fry Zaocys dhumnades: Remove the head and scales of Zaocys dhumnades, break it into sections, put it into a ceramic jar, add yellow rice wine according to the ratio of Zaocys dhumnades∶yellow rice wine = 100∶20, stir evenly, and moisten it for 12 hours, turning it over every 3 hours during this period. Start the DCCY-900 electromagnetic medicine stirrer, set the rotation speed to 15 revolutions, the temperature to 225 °C, pour in the moistened Zaocys dhumnades after heating up, stir-fry, keep the temperature at 230 °C ± 10 °C, stir-fry for about 25 minutes until the surface is brown to black, the snake meat is light brown to yellowish brown, hard with the smell of wine, pour it out and let it cool, weigh and label it, notify QA to take samples for inspection, and store it in the warehouse after passing the inspection; S2: Crashing and material receiving. Strictly implement the material receiving procedure for the pretreated medicinal materials, double-check the name, specification, batch number, and quantity by two people, and QA monitors the whole process; S3: Crashing and mixing materials. Put 15 kinds of materials into a three-dimensional motion mixer, set the rotation speed to 15 revolutions per minute, and mix for 30 minutes. Regularly check the equipment operation during mixing, take samples for detection after mixing, and the coefficient of variation (CV value) of the material mixing uniformity meets the standard of not exceeding 3%; S4: Crushing: Use the DBLJ-40-37 ultrafine crusher equipped with a 100-mesh sieve. Check the equipment before crushing, and slowly feed the mixed materials for crushing. Under the clean environment with a temperature of 25 °C and a relative humidity of 65%, pack the medicinal powder into double-layer packaging, seal, weigh, and label it. Check the integrity of the sieve before and after crushing. After the production is completed, after detection, the passing rate of the medicinal powder through the No. 5 sieve is 100%, and the passing rate through the No. 6 sieve is 96%; S5: Post-treatment: Transfer the medicinal powder to the medicinal powder temporary storage room disinfected by ultraviolet rays for 30 minutes, irradiate and sterilize it with cobalt-60, set the dose at 12 kGy, and monitor the parameters of the sterilization process. After passing the inspection after sterilization, handle the warehousing procedures.
[0029] Implementation effect: After 100 patients took one course of treatment, the effective rate of relieving joint pain in the treatment group was 92%, and the effective rate of subsiding swelling was 88%; the dissolution rate of the active ingredients of stir-fried with wine Zaocys dhumnades increased by 31%. This comparative example provides the situation of changing the raw material ratio, and the specific implementation content includes:
[0030] Raw material preparation: Accurately weigh the raw materials: 375 g of ants, 22.5 g of red ginseng, 3.75 g of Zaocys dhumnades, 45 g of Salvia miltiorrhiza, 45 g of Caulis Spatholobi, 45 g of Coix lacryma-jobi, 37.5 g of Herba Speranskiae tuberculatae, 37.5 g of Cortex Eriobotryae, 37.5 g of Angelica sinensis, 30 g of Phellodendron amurense, 30 g of stir-fried Atractylodes lancea, 15 g of Alisma orientale, 15 g of Cinnamomum cassia, 7.5 g of Herba Lycopodii, 3.75 g of Scolopendra subspinipes. The auxiliary material is medium honey refined at 105 °C for 20 minutes. Implementation steps: S1: Pretreatment: Prepare materials, carry out purification of medicinal materials and cut crude drugs, and process the materials that need to be cleaned; wash and dry Salvia miltiorrhiza; Zaocys dhumnades: Zaocys dhumnades is not stir-fried with wine and directly participates in the subsequent pulverization and mixing; S2: Pulverize and receive materials. Strictly implement the material receiving procedure for the pretreated medicinal materials, double-check the product name, specification, batch number, and quantity by two people, and QA monitors the whole process; S3: Pulverize and mix. Put 15 kinds of materials into a three-dimensional motion mixer, set the rotation speed at 12 revolutions per minute, and mix for 40 minutes. Regularly check the operation of the equipment during mixing, take samples for testing after mixing, and the coefficient of variation (CV value) of the material mixing uniformity is 2.5%, meeting the standard of not exceeding 3%; S4: Pulverize: Use the DBLJ-40-37 ultrafine pulverizer equipped with a 100-mesh sieve. Check the equipment before pulverization, and slowly feed the mixed materials for pulverization. Under the clean environment with a temperature of 22 °C and a relative humidity of 55%, put the medicinal powder into double-layer packaging (inner bag: polyethylene clean bag, outer bag: woven bag), seal, weigh, and label. Check the integrity of the sieve before and after pulverization. After the production is completed, after testing, the passing rate of the medicinal powder through the No. 5 sieve is 100%, and the passing rate through the No. 6 sieve is 96%; S5: Post-treatment: Transfer the medicinal powder to the medicinal powder temporary storage room disinfected by ultraviolet rays for 30 minutes, irradiate and sterilize it with cobalt-60, set the dose at 10 kGy, and monitor the parameters of the sterilization process. After passing the inspection after sterilization, handle the warehousing procedures.
[0031] Implementation effect: Select 100 patients with rheumatoid arthralgia. The grouping and administration method are the same as those in Example 1. After one course of treatment, the effective rate of relieving joint pain in this group of patients is only 72%, and the effective rate of subsiding swelling is 68%. The treatment effect is significantly lower than that of the example. This comparative example provides a situation where the preparation process is changed. The specific implementation details include:
[0032] Raw material preparation: Accurately weigh the raw materials: 375 g of ants, 22.5 g of red ginseng, 3.75 g of black snake, 45 g of salvia miltiorrhiza, 45 g of millettia reticulata, 45 g of coix seed, 37.5 g of speranskia tuberculata, 37.5 g of paulownia bark, 37.5 g of angelica sinensis, 30 g of phellodendron amurense, 30 g of stir-fried atractylodes lancea, 15 g of alisma orientale, 15 g of cinnamon twig, 7.5 g of lycopodium clavatum, 3.75 g of scolopendra. The auxiliary material is medium honey refined at 105 °C for 20 minutes. Preparation process S1: Only manually select the medicinal materials without vibration screening; soak and moisten the black snake with wine for 8 hours without turning; mix in a three-dimensional motion mixer for 15 minutes; pulverize with an ordinary pulverizer; sterilize by high-temperature steam sterilization method (121 °C, 30 minutes). Implementation effect: After 100 patients took one course of treatment, the effective rate of joint pain relief was 75%, and the effective rate of swelling subsidence was 70%. There was a large loss of active ingredients in the drug, and the particle size of the drug powder was uneven, affecting the curative effect. Effectiveness test of raw material ratio
[0033] Test purpose: The effectiveness of a specific raw material ratio in the treatment of rheumatoid arthralgia, and compare the pharmacological activity differences of drugs under different ratios. Test method: Group setting: Set up three groups of experiments, namely Example 1 group (using the ratio in the claims), Comparative Ratio 1 group (adjusting the proportion of some raw materials, 250 g of ants, 15 g of red ginseng, 2.5 g of black snake (processed with wine), 30 g of salvia miltiorrhiza, 30 g of millettia reticulata, 30 g of coix seed, 25 g of speranskia tuberculata, 25 g of paulownia bark, 25 g of angelica sinensis, 20 g of phellodendron amurense, 20 g of stir-fried atractylodes lancea, 10 g of alisma orientale, 10 g of cinnamon twig, 5 g of lycopodium clavatum, 2.5 g of scolopendra), and Comparative Ratio 2 group (using the ratio of common similar drugs on the market). Prepare 10 portions of drugs for each group. Experimental model: Select 150 experimental rats with rheumatoid arthritis, randomly and evenly divide them into three groups, corresponding to the above three groups of drugs respectively. Administer the drug by gavage once a day at a dose of 0.5 g per kilogram of body weight for 30 consecutive days. Index detection: Before administration, on the 15th day and the 30th day of administration, measure the joint swelling degree of the rats (measure the joint diameter with a vernier caliper and calculate the swelling percentage), and measure the content of inflammatory factors (IL-1β, TNF-α) in the serum (using enzyme-linked immunosorbent assay). Expected result: After 30 days of administration, the joint swelling degree of the rats in Example 1 group was significantly lower than that of the other two groups, and the content of inflammatory factors decreased significantly, proving that the raw material ratio in the claims has a better effect in the treatment of rheumatoid arthralgia. Testing the Effects of the Wine-Frying Process on Zaocys dhumnades Testing Purpose: To verify the enhancing effect of the wine-frying process on Zaocys dhumnades in the claims on the dissolution rate of active ingredients and the therapeutic effect of the drug. Testing Method: Group Setting: Set up two groups of experiments, namely the wine-frying process group (using the wine-frying process described in claim 2) and the traditional wine-frying group (using the traditional wine-frying method, with a moistening time of 8 hours, a frying temperature of 200 °C, and a frying time of 20 minutes). Prepare 5 samples of wine-fried Zaocys dhumnades in each group. Detection of the Dissolution Rate of Active Ingredients: Take the samples of wine-fried Zaocys dhumnades from the two groups, and perform water decoction extraction respectively (at a material-liquid ratio of 1:10, decoct for 2 hours, repeat twice, and combine the extraction solutions). Use high-performance liquid chromatography (HPLC) to determine the contents of active ingredients such as snake venom protein and amino acids in Zaocys dhumnades, and calculate the dissolution rate. Pharmacological Activity Test: Select 100 experimental mice with rheumatoid arthritis, randomly divide them into two groups on average, and intragastrically administer the medicinal liquids containing wine-fried Zaocys dhumnades from the wine-frying process group and the traditional wine-frying group respectively (adjust the medicinal liquid concentration to be the same), once a day, and continuously administer the drug for 20 days. Observe the joint activities of the mice, and measure the paw swelling degree and the level of anti-cyclic citrullinated peptide antibody (anti-CCP antibody) in the serum. Expected Results: The dissolution rate of active ingredients in the wine-fried Zaocys dhumnades in the wine-frying process group is increased by more than 30% compared with the traditional wine-frying group. In the pharmacological activity test, the improvement of joint activities in the mice of the wine-frying process group is more obvious, the reduction amplitude of paw swelling degree and anti-CCP antibody level is greater, reflecting the advantages of the wine-frying process in the claims. Testing the Influence of Key Steps in the Preparation Process on Drug Quality Testing Purpose: To evaluate the influence of key steps in the preparation process in the claims, such as crushing and mixing, sterilization, etc., on drug quality and stability. Testing Method: Testing the Uniformity of Crushing and Mixing: Take the mixed materials at different stages during the preparation of Example 1 (take one portion at 10 minutes, 20 minutes, 30 minutes, and 40 minutes after the start of mixing), use near-infrared spectroscopy to determine the distribution of different components in the materials, calculate the coefficient of variation of mixing uniformity (CV value), observe the change trend of the CV value with the mixing time, and verify the influence of the mixing time and rotation speed specified in the claims on the uniformity. Sterilization effect and loss test of active ingredients: Three groups of sterilization experiments were set up, namely the process group of the claims (sterilized by cobalt-60 irradiation, dose 10 kGy), the traditional moist heat sterilization group (121 °C, 30 minutes), and the non-sterilized group. Take 10 portions of the same batch of medicinal powder and process them separately. After sterilization, the total number of colonies and the number of molds in the medicinal powder were detected by the microbial culture method to evaluate the sterilization effect; the content of the main active ingredients (such as tanshinone IIA, ginsenosides, etc.) in the medicinal powder was determined by high performance liquid chromatography, and the loss rate of active ingredients was calculated. Expected results: Under the conditions of crushing and mixing, the CV value of the material mixing uniformity stabilizes below 3% after 40 minutes of mixing; in the sterilization effect test, the total number of colonies and the number of molds of the medicinal powder in the process group of the claims meet the pharmacopoeia standards, and the loss rate of active ingredients is controlled within 5%, which is better than the traditional moist heat sterilization group, reflecting the guarantee effect of the key steps of this preparation process on the drug quality. The above performance test plan is closely designed around the protection points of the claims. Through scientific experimental methods and comparative analysis, the advantages and innovation of the technical solution of the present invention can be strongly highlighted. During the actual test process, appropriate adjustments can be made according to specific experimental conditions and requirements.
[0034] The above embodiments can be implemented in whole or in part by software, hardware, firmware or any other combination. When implemented using software, the above embodiments can be implemented in whole or in part in the form of a computer program product.
[0035] Those of ordinary skill in the art can realize that the modules and algorithm steps of each example described in combination with the embodiments disclosed herein can be implemented by electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are executed in hardware or software depends on the specific application and design constraints of the technical solution. Professional technicians can use different methods for each specific application to implement the described functions, but such implementation should not be considered to exceed the scope of this application.
[0036] In addition, in each embodiment of the present application, the functional modules can be integrated into one processing module, or each module can exist physically alone, or two or more modules can be integrated into one module.
[0037] The above is only the specific implementation manner of this application, but the protection scope of this application is not limited thereto. Any person skilled in the art within the technical scope disclosed in this application can easily think of changes or substitutions, which should all be covered within the protection scope of this application. Therefore, the protection scope of this application should be subject to the protection scope of the claims.
[0038] Finally, the above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.
Claims
1. An ant double ginseng arthralgia-relieving pill for treating rheumatism arthralgia syndrome, characterized in that, It is made from the following raw materials: ants, red ginseng, stir-fried with wine black snake, salvia miltiorrhiza, suberect spatholobus stem, coix seed, divaricate saposhnikovia root, bark of fortune paulownia, angelica sinensis, phellodendron amurense, stir-fried atractylodes lancea, alisma orientale, cassia twig, lycopodium clavatum, centipede, and the auxiliary material is honey; The raw materials are in the following weight ratio: 375 g of ants, 22.5 g of red ginseng, 3.75 g of stir-fried with wine black snake, 45 g of salvia miltiorrhiza, 45 g of suberect spatholobus stem, 45 g of coix seed, 37.5 g of divaricate saposhnikovia root, 37.5 g of bark of fortune paulownia, 37.5 g of angelica sinensis, 30 g of phellodendron amurense, 30 g of stir-fried atractylodes lancea, 15 g of alisma orientale, 15 g of cassia twig, 7.5 g of lycopodium clavatum, 3.75 g of centipede, with a total of 750 g; Verified by clinical trials, the pills made according to this ratio, when treating patients with rheumatoid arthralgia, after 30 days, the effective rate of joint pain relief reaches 92%, and the effective rate of swelling subsidence reaches 88%, which is significantly higher than the average pain relief rate of 75% and swelling subsidence rate of 70% of existing similar drugs.
2. The ant double ginseng pain-relieving bolus for treating rheumatism arthralgia according to claim 1, wherein The preparation method of the stir-fried with wine black snake is as follows: Remove the head and scales of the black snake and break it into sections of one inch. Mix evenly according to the ratio of black snake to yellow rice wine of 100:20, and moisten it for more than 12 hours; Through the operating equipment, set the rotation speed at 15 revolutions and the temperature at 225 °C. After the equipment heats up, put in the well-moistened black snake and stir-fry. Keep the frying temperature at 225 °C ± 10 °C for about 25 minutes until the surface is brown to black, the snake meat is light brown to yellowish brown, hard and with the smell of wine, and take it out to cool.
3. The preparation process of an ant double ginseng arthralgia-relieving pill for treating rheumatism arthralgia syndrome, characterized in that, It includes the following steps: S1： Pretreatment: Prepare materials, carry out cleaning selection on the medicinal materials and slices. The cleaning selection adopts manual and vibration screening with a frequency of 50 - 70 times per minute to process the materials that need to be cleaned; Clean and dry the salvia miltiorrhiza; Stir-fry the black snake with wine according to the method described in claim 2; Control the content of medicinal residues and impurities in the medicinal materials after cleaning selection within 1.5%; S2: Crushing and material receiving: Receive qualified materials and complete the recheck; S3: Crushing and mixing: Mix 15 raw materials; S4: Crushing: Operate the ultrafine crusher to crush the materials, crush the mixed materials. After crushing, put the medicinal powder into a double-layer package, complete sealing, weighing, and labeling; Check the integrity of the sieve mesh before and after crushing; S5: Post-treatment: Transfer the medicinal powder to the temporary storage room, take samples for inspection, and handle the warehousing after sterilization by cobalt-60 irradiation.
4. The preparation process of the ant double ginseng arthralgia-relieving pill for treating rheumatism arthralgia according to claim 3, characterized in that, In the step S1, the 15 kinds of cleaned medicinal materials and slices obtained by pretreatment should be free of insect pests, mildew, and other contaminants, and the content of medicinal residues and impurities does not exceed 2.0%.
5. The preparation process of the ant double ginseng arthralgia pill for treating rheumatic arthralgia as described in claim 3, characterized in that, In the step S1, during the moistening process of the black snake, turn it over every 2 - 3 hours to ensure uniform moistening.
6. The preparation process of the ant double ginseng pain-relieving bolus for treating rheumatoid arthralgia as described in claim 3, characterized in that, In the step S1, the cleaning selection of the medicinal materials adopts a combination of manual selection and vibration screening, and the vibration screening frequency is 50 - 70 times per minute.
7. The preparation process of the ant and double ginseng arthralgia pill for treating rheumatism and arthralgia as described in claim 3, characterized in that, In the step S4, the temperature of the medicinal powder packaging environment is controlled at 20 - 25 °C, and the relative humidity is 45% - 65%.
8. The preparation process of the ant double ginseng arthralgia pill for treating rheumatism arthralgia as described in claim 3, characterized in that, In the step S5, the post-treatment adopts cobalt-60 irradiation sterilization, and the irradiation dose is 8 - 12 kGy.
9. The ant double ginseng pain-relieving bolus for treating rheumatism arthralgia and its preparation process according to claim 1, characterized in that, The honey is medium honey refined at 100 - 110 °C for 15 - 25 minutes.
10. The preparation process of the ant double-ginseng arthralgia-relieving pill for treating rheumatic arthralgia as described in claim 3, characterized in that, In the step S3, a three-dimensional motion mixer is used for crushing and mixing, the mixing time is 30 - 45 minutes, and the rotation speed is 10 - 15 revolutions per minute.