Formula and preparation method of bezoar detoxification capsule

Abstract

The invention relates to the technical field of pharmaceutical preparations, and discloses a formula and a preparation method of a bezoar detoxification capsule, and the method comprises the following steps: crushing and screening artificial bezoar, nano realgar, glycyrrhizic acid, rheum officinale, scutellaria baicalensis, platycodon grandiflorum and liquorice, performing ultrasonic extraction on gypsum, dissolving borneol, performing ultrasonic extraction, and drying to obtain the bezoar detoxification capsule. Crushing the honeysuckle flower extract, the fructus forsythiae extract, the herba violae extract, the radix isatidis extract and the fructus arctii extract; mixing the treated gypsum powder, rhubarb powder, scutellaria baicalensis powder, platycodon grandiflorum powder, liquorice powder, honeysuckle extract powder, fructus forsythiae extract powder, philippine violet herb extract powder, isatis root extract powder and burdock extract powder, preparing a solution, spraying the solution on the mixed powder to prepare a soft material, granulating, adding treated calculus bovis factitius powder, nano realgar powder, glycyrrhizic acid powder and borneol powder, uniformly mixing, and granulating to obtain a finished product. The bezoar detoxification mixture filled capsule is obtained. The calculus bovis detoxification capsule has the effects of clearing away heat and toxic materials, reducing toxicity and improving the component extraction rate and utilization rate.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, in particular to a formula of Niuhuang Jiedu capsule and a preparation method thereof. Background Art

[0002] Niuhuang Jiedu Capsules are a commonly used traditional Chinese medicine for clearing heat and detoxifying, primarily used to treat symptoms such as sore throat and swollen gums caused by internal heat. However, the existing formulation and preparation process still present numerous challenges that need to be addressed. Regarding the formulation, some ingredients in traditional Niuhuang Jiedu Capsules present difficulties in balancing safety and efficacy. For example, while realgar has detoxifying properties, its arsenic content poses significant toxic risks, and traditional technologies struggle to effectively control its potential hazards. Furthermore, with increasing clinical demand, traditional formulations are no longer able to meet the comprehensive anti-inflammatory, antibacterial, and antiviral therapeutic needs of complex conditions, necessitating optimization of ingredient combinations and ratios. Regarding the preparation process, traditional methods, such as aqueous extraction of medicinal materials and wet granulation, suffer from low active ingredient extraction yields, uneven granule quality, and slow drug dissolution, resulting in insufficient bioavailability and impacting efficacy. Furthermore, traditional processes struggle to prevent the loss of volatile ingredients, such as borneol, during the production process, leading to unstable product quality. At the same time, traditional processes are unable to meet the requirements of modern large-scale production for product uniformity, stability and efficiency in terms of production efficiency and quality control. With the modernization of traditional Chinese medicine and the improvement of patients' requirements for drug quality, there is an urgent need for a new formula and preparation process that can enhance the efficacy of Niuhuang Jiedu Capsules, reduce the risk of toxicity, and improve production efficiency and quality stability. Summary of the Invention

[0003] The present invention provides a formula of Niuhuang Jiedu Capsule and a preparation method thereof. By optimizing the formula and process, the effects of Niuhuang Jiedu Capsule in clearing away heat and detoxifying, and reducing toxicity are enhanced, while the extraction rate and utilization rate of the ingredients are increased, the dissolution rate is improved, the quality is guaranteed to be stable, and the production efficiency is improved.

[0004] The present invention provides a formula of Niuhuang Jiedu Capsule, comprising the following components: Artificial bezoar 4.5~5.5% Nano realgar 3.5~4.5% Gypsum 23~26% Rhubarb 19~21% Scutellaria baicalensis 17-19% Platycodon grandiflorum 10~12% Borneol 2.5~3% Licorice 5-6% Honeysuckle extract 12~14% Forsythia suspensa extract 9~13% 8~10% of edema yedoensis extract Isatis root extract 7~9% Burdock fruit extract 6~8% Glycyrrhizic acid 1~5% β-cyclodextrin 8~9% Povidone K30 2~2.5% Pharmaceutical grade starch residue The above percentages are weight percentages, and the sum of the components constitutes 100% of the total weight percentage of the Niuhuang Jiedu Capsule formula.

[0005] The present invention also provides a preparation method of Niuhuang Jiedu Capsule. Based on the formula of Niuhuang Jiedu Capsule described above, the preparation method specifically comprises: S1, according to the formula of described Niuhuang Jiedu Capsule, accurately weigh each component of setting weight percentage; S2, crushing and screening the combination of artificial bezoar, nano-realgar, and glycyrrhizic acid, crushing and screening the combination of rhubarb, scutellaria, platycodon, and licorice, ultrasonically extracting the gypsum, dissolving the borneol, and crushing the honeysuckle extract, forsythia extract, Viola yedoensis extract, isatis root extract, and arctium fruit extract; S3, mixing the gypsum powder, rhubarb powder, scutellaria powder, platycodon powder, licorice powder, honeysuckle extract powder, forsythia extract powder, Viola yedoensis extract powder, isatis root extract powder, and burdock fruit extract powder after the treatment in step S2 in a mixer for 30 to 40 minutes to obtain a premixed powder; S4. Prepare a 5% (w / v) povidone K30 ethanol solution, slowly spray the solution on the premixed powder and stir to form a soft material that can be held in the hand, and use the soft material to granulate using a granulator to obtain mixed granules; S5, the mixed particles are put into a mixer, and the artificial bezoar powder, nano realgar powder, glycyrrhizic acid powder and borneol powder after step S2 are added in sequence to obtain a bezoar detoxification mixture; S6, filling the Niuhuang Jiedu mixture into capsules, and performing quality inspection to obtain the Niuhuang Jiedu capsules.

[0006] Furthermore, in step S2, the combination of artificial bezoar, nano-realgar and glycyrrhizic acid is subjected to a crushing and screening process, specifically: The artificial bezoar, nano-realgar and glycyrrhizic acid are respectively pulverized by a jet mill, wherein the artificial bezoar and glycyrrhizic acid are passed through a 100-mesh sieve, and the nano-realgar is monitored by a laser particle size analyzer to ensure that more than 90% of the particles are less than 100 nm in size, thereby obtaining artificial bezoar powder, nano-realgar powder and glycyrrhizic acid powder.

[0007] Furthermore, in step S2, the combination of rhubarb, scutellaria, platycodon grandiflorum, and liquorice is subjected to another crushing and screening process, specifically comprising: The rhubarb, scutellaria, platycodon and liquorice are pulverized by adopting a low-temperature pulverization technology with -20°C liquid nitrogen precooling, and the pulverized rhubarb, scutellaria, platycodon and liquorice are sieved with 80 meshes to obtain rhubarb powder, scutellaria powder, platycodon powder and liquorice powder.

[0008] Furthermore, in step S2, ultrasonic extraction is performed on the gypsum, specifically comprising: The gypsum is placed in an ultrasonic extraction tank, and 8 to 10 times the amount of purified water is added to perform ultrasonic extraction twice, each time for 40 to 50 minutes. The extract is filtered through a plate and frame filter press, and the filtrate is concentrated under reduced pressure in a vacuum concentration tank to a relative density of 1.2 to 1.3, and then dried. After drying, the gypsum is crushed and passed through an 80-mesh sieve to obtain gypsum powder.

[0009] Furthermore, in step S2, the borneol is dissolved, specifically comprising: The borneol and β-cyclodextrin are prepared in a ratio of 1:3, the β-cyclodextrin is first added to 60-70°C purified water, stirred to dissolve, and then the borneol is added, and the mixture is transferred to an ultrasonic inclusion reactor for inclusion for 1-1.5 hours. The obtained inclusion compound is dried in a vacuum drying oven and then crushed through an 80-mesh sieve to obtain borneol powder; wherein the weight of the added purified water is 8-10 times that of the β-cyclodextrin.

[0010] Furthermore, in step S2, the honeysuckle extract, forsythia suspensa extract, Viola yedoensis extract, isatis root extract, and burdock fruit extract are pulverized, specifically comprising: The honeysuckle extract, forsythia extract, viola yedoensis extract, isatis root extract, and burdock fruit extract were tested for effective ingredient content, and were crushed to 100 mesh using an ultrafine grinder. After crushing, a particle size distribution test was performed to ensure that the D90 particle size was ≤150 μm to obtain honeysuckle extract powder, forsythia extract powder, viola yedoensis extract powder, isatis root extract powder, and burdock fruit extract powder.

[0011] Furthermore, the step S4 specifically includes: S401. Prepare a 5% (w / v) povidone K30 ethanol solution with an ethanol concentration of 70%. Slowly spray the solution onto the premixed powder while stirring at a speed of 50-60 r / min to form a soft material. Adjust the amount of solution according to the state of the soft material, using the standard that the powder forms a ball when held by hand, falls apart when lightly pressed, and does not stick to the hand after releasing the hand; S402, put the soft material into the fluidized bed granulator, and set the preheating inlet air to 70~75 DEG C, the inlet air volume to 80~100 m3 / h, the atomization pressure to 0.2~0.3 MPa, and the liquid spraying speed to 5~8 mL / min; the granulation process is monitored in real time to ensure that the particle temperature is in the range of 55~60 DEG C, the granulation is completed, the particles are sieved through a 16-mesh sieve, and the particles are dried in a hot air circulating drying box until the moisture content is less than or equal to 5%, thereby obtaining mixed particles.

[0012] Further, the step S5 specifically comprises: S501, put the mixed particles into a double-cone rotary mixer, and sequentially add the artificial ox gall powder, nano cinnabar powder and glycyrrhizic acid powder, and mix at a rotation speed of 12~15 r / min for 15~20 minutes; S502, add the inclusion ice powder, and continue to mix for 10~15 minutes; after mixing, the content uniformity is detected, thereby obtaining the ox gall detoxification mixture.

[0013] The present application has the following advantages: In the formula aspect, the present application adjusts the component ratio and introduces new components, which not only enhances the comprehensive effects of heat-clearing and detoxifying, anti-inflammatory and detumescence, antibacterial and antiviral, but also significantly reduces the potential safety risk through technical improvement and reasonable compatibility of toxic components; further expands the drug targeting for multiple diseases. In the preparation method, modern extraction, granulation and mixing technologies are adopted, which greatly improves the extraction rate and utilization rate of effective components of medicinal materials, and through precise process control, the quality of the granules is uniform, the components are evenly dispersed, the dissolution rate and bioavailability of the drug are effectively improved; the special treatment process for volatile components greatly reduces the component loss and ensures the stability of the product quality. Ultimately, the present application can not only enhance the therapeutic effect of ox gall detoxification capsules and reduce the toxicity risk, but also improve the production efficiency and quality stability. BRIEF DESCRIPTION OF DRAWINGS

[0014] Figure 1 The figure is a flowchart of the preparation method of the ox gall detoxification capsule.

[0015] The implementation, functional features and advantages of the present application will be further described with reference to the embodiments and the accompanying drawings. DETAILED DESCRIPTION

[0016] It should be understood that the specific embodiments described herein are only used to explain the present application, and are not used to limit the present application.

[0017] The invention provides a formula of a Niuhuang Jiedu capsule, comprising the following components: 4.5-5.5% artificial bezoar, 3.5-4.5% nano realgar, 23-26% gypsum, 19-21% rhubarb, 17-19% scutellaria, 10-12% platycodon, 2.5-3% borneol, 5-6% liquorice, 12-14% honeysuckle extract, 9-13% forsythia extract, 8-10% philadelphica extract, 7-9% isatis root extract, 6-8% burdock fruit extract, 1-5% glycyrrhizic acid, 8-9% beta-cyclodextrin, 2-2.5% povidone K30, and the balance being pharmaceutical-grade starch. The above percentages are by weight, and the total weight percentage of the components constitutes 100% of the Niuhuang Jiedu capsule formula.

[0018] Among the above components, artificial bezoar, used as the main ingredient, is used in dosage adjusted based on a balance between cost and efficacy. It possesses the core benefits of clearing heat and detoxifying, resolving phlegm and invigorating the mind. It effectively eliminates heat and toxins from the body and has a significant therapeutic effect on symptoms of internal heat, such as sore throat and mouth sores. Its bile acid and deoxycholic acid, among other ingredients, regulate the body's immune function and enhance anti-inflammatory effects, making it a key component in the heat-clearing effect of Niuhuang Jiedu Capsules.

[0019] Nano-realgar, gypsum, rhubarb, and scutellaria baicalensis serve as auxiliary herbs. After being processed with nanotechnology, nano-realgar reduces the risk of toxicity while retaining its detoxifying, insecticidal, dampness-drying, and expectorant properties. It assists artificial bezoar in enhancing its detoxifying efficacy, and is particularly effective in treating symptoms such as boils and eczema. Gypsum excels at clearing heat and purging fire, relieving restlessness and thirst, and primarily clears excess heat in the Yangming meridian, alleviating symptoms such as high fever and thirst. It synergizes with the main herbs to enhance its heat-clearing power. Rhubarb has the effects of purging accumulation, clearing heat and purging fire, cooling the blood, and detoxifying. It promotes bowel movements, expelling heat and toxins from the intestines, relieving symptoms such as constipation and swollen and painful gums, and regulating the release of internal heat pathogens. Scutellaria baicalensis excels at clearing heat and dampness, purging fire, and detoxifying. It is particularly adept at clearing damp-heat in the upper Jiao, and has a good effect on symptoms such as red and swollen eyes and coughs caused by lung heat. It synergizes with other ingredients to exert anti-inflammatory and antibacterial effects.

[0020] Platycodon grandiflorum, honeysuckle extract, forsythia extract, viola philippica extract, radix isatidis extract, and arctium lappa extract as auxiliary drugs; Platycodon grandiflorum can promote lung and relieve sore-throat, expel phlegm and pus, and can also carry other drugs to the disease site, thereby enhancing the treatment effect on throat diseases, and adjusting the drugs to make the drug distribution more uniform. Honeysuckle extract is rich in chlorogenic acid, luteolin and other components, has strong anti-inflammatory and antibacterial effects, can enhance the treatment effect of Niuhuang Jiedu Capsules on respiratory tract infection, skin inflammation and other diseases, and assist the monarch drug to improve the comprehensive effect of clearing heat and resolving toxins. Forsythia extract has the effects of relieving fever, anti-virus and anti-inflammatory, can assist in the treatment of fever, viral infection and other symptoms, and synergistically acts with honeysuckle extract to enhance the overall anti-virus capacity of the drug. Violate philippica extract has the main effects of cooling blood and reducing swelling, and can quickly relieve redness, swelling, heat and pain, thereby enhancing the treatment effect of the drug on local inflammation such as gum swelling and sore, and sore. Radix isatidis extract has the effects of clearing heat and resolving toxins, and cooling blood and benefiting throat, has significant effects on sore-throat, viral pharyngitis and other diseases, and is an important component for relieving symptoms of upper respiratory tract infection. Arctium lappa extract can dispel wind-heat and detoxify and resolve rash, and can effectively relieve symptoms such as red and swollen eyes, skin rash and other symptoms, and synergistically acts with other components to expand the treatment range of the drug.

[0021] Glycyrrhiza and glycyrrhizic acid as a drug, Glycyrrhiza can adjust the drugs, moderate the harsh nature of other drugs in the prescription, make the drug effect last and slow down, and also has certain effects of clearing heat and resolving toxins, reduces the toxicity of realgar and other components, and enhances the safety and stability of the prescription.

[0022] Borneol, β-cyclodextrin, povidone K30, and pharmaceutical grade starch as auxiliary materials, borneol has the effects of opening the orifice, refreshing the mind, clearing heat and relieving pain, can enhance the heat-clearing and swelling-reducing effect of the drug, and quickly relieve pain symptoms, and its volatility helps the transdermal absorption and rapid effect of the drug components; β-cyclodextrin can reduce the volatilization loss of borneol during production and storage, and ensure the stability of the components. β-cyclodextrin as a complexing material forms a complex with borneol to improve the stability of borneol, reduce its volatilization loss, and ensure the consistency of the efficacy of the drug during storage and use. Povidone K30 (PVP K30) as a binder in the granulation process can effectively bond the powder particles to form soft materials with good flowability and compressibility, ensuring the quality of particle formation and facilitating the smooth progress of subsequent capsule filling process. Starch (pharmaceutical grade) adjusts the granulation molding, acts as a diluent and filler to adjust the density and flowability of the particles, and also helps to control the weight of the capsule contents, ensuring the consistency of product specifications.

[0023] For example, Figure 1As shown, the application also provides a preparation method of the Beizhuyu Jieyu Capsule, based on the formula of the Beizhuyu Jieyu Capsule as described above, and the preparation method specifically comprises: S1, accurately weighing each component according to the formula of the Beizhuyu Jieyu Capsule. For example, the set content of each component is as follows: artificial bovine bezoar 45g, accounting for 5.06%; nanometer realgar 35g, accounting for 3.94%; gypsum 220g, accounting for 24.72%; rhubarb 180g, accounting for 20.22%; Huangqi 160g, accounting for 17.98%; Jiegeng 100g, accounting for 11.24%; Bingpian 25g, accounting for 2.81%; Gancao 50g, accounting for 5.62%; Jinyinhua extract 120g, accounting for 13.43%; Lianqiao extract 100g, accounting for 11.24%; Zihuandiding extract 80g, accounting for 8.99%; Banlangen extract 80g, accounting for 8.99%; Niubangzi extract 60g, accounting for 6.74%; Gancao acid 10g, accounting for 1.12%; β-cyclodextrin 75g, accounting for 8.43%; povidone K30 20g, accounting for 2.25%; and the rest is medicinal starch.

[0024] S2, performing a crushing and screening treatment on the combination of artificial bovine bezoar, nanometer realgar and Gancao acid, performing another crushing and screening treatment on the combination of rhubarb, Huangqi, Jiegeng and Gancao, performing ultrasonic extraction on the gypsum, performing dissolution treatment on the Bingpian, and performing crushing treatment on the Jinyinhua extract, Lianqiao extract, Zihuandiding extract, Banlangen extract and Niubangzi extract.

[0025] S201, performing a crushing and screening treatment on the combination of artificial bovine bezoar, nanometer realgar and Gancao acid, specifically as follows: The artificial bovine bezoar, nanometer realgar and Gancao acid are crushed by using an air flow crusher, wherein the artificial bovine bezoar and Gancao acid are passed through a 100-mesh screen, and the nanometer realgar is crushed under the monitoring of a laser particle size analyzer to ensure that more than 90% of the particles have a particle size of less than 100 nm, thereby obtaining artificial bovine bezoar powder, nanometer realgar powder and Gancao acid powder. During the crushing process, the environmental temperature is kept at ≤25℃ and the humidity is kept at ≤45% to prevent the components from denaturation or adhesion.

[0026] S202, performing another crushing and screening treatment on the combination of rhubarb, Huangqi, Jiegeng and Gancao, specifically comprising: The rhubarb, Huangqi, Jiegeng and Gancao are crushed by using a low-temperature crushing technology with pre-cooling of liquid nitrogen at -20℃, and then passed through an 80-mesh screen to obtain rhubarb powder, Huangqi powder, Jiegeng powder and Gancao powder.

[0027] S203, performing ultrasonic extraction on the gypsum, specifically comprising: The gypsum is placed in an ultrasonic extraction tank, 8 to 10 times the amount of purified water is added, the ultrasonic power is set to 300 to 350 W, the frequency is 40 kHz, the extraction is performed twice, each time for 40 to 50 minutes, the extract is filtered through a plate and frame filter press, the filtrate is concentrated under reduced pressure in a vacuum concentration tank (temperature 55 to 65° C., vacuum degree -0.06 to -0.08 MPa) to a relative density of 1.2 to 1.3, and then transferred to a spray drying tower with an air inlet temperature of 180 to 190° C. and an air outlet temperature of 80 to 90° C. After drying, the gypsum is crushed and passed through an 80-mesh sieve to obtain gypsum powder.

[0028] S204, dissolving the borneol, specifically comprising: The borneol and β-cyclodextrin are prepared in a ratio of 1:3, the β-cyclodextrin is first added to 60-70°C purified water, stirred to dissolve, and then the borneol is added, and the mixture is transferred to an ultrasonic inclusion reactor. The inclusion complex is included at 60°C and an ultrasonic power of 200W for 1-1.5 hours. The inclusion complex is dried in a vacuum drying oven (temperature 50-55°C, vacuum degree -0.06MPa) and then crushed through an 80-mesh sieve to obtain borneol powder; wherein the weight of the added purified water is 8-10 times that of the β-cyclodextrin.

[0029] S205, crushing the honeysuckle extract, forsythia suspensa extract, Viola yedoensis extract, isatis root extract, and burdock fruit extract, specifically comprising: The honeysuckle extract, forsythia extract, viola yedoensis extract, isatis root extract, and burdock fruit extract were tested for effective ingredient content, and were crushed to 100 mesh using an ultrafine grinder. After crushing, a particle size distribution test was performed to ensure that the D90 particle size was ≤150 μm to obtain honeysuckle extract powder, forsythia extract powder, viola yedoensis extract powder, isatis root extract powder, and burdock fruit extract powder.

[0030] S3. The gypsum powder, rhubarb powder, scutellaria powder, platycodon powder, licorice powder, honeysuckle extract powder, forsythia extract powder, viola yedoensis extract powder, isatis root extract powder, and burdock fruit extract powder treated in step S2 are mixed using a three-dimensional motion mixer, with a set speed of 15-20 r / min and a mixing time of 30-40 minutes to obtain a premixed powder.

[0031] S4. Prepare a 5% (w / v) povidone K30 ethanol solution, slowly spray the solution onto the premixed powder and stir to form a soft material that can be held in the hand, and use the soft material to granulate using a granulator to obtain mixed granules. Specifically, the steps include: S401, a 5% (w / v) povidone K30 ethanol solution is prepared, wherein the ethanol concentration is 70%, and the solution is slowly sprayed on the premixed powder while stirring at a speed of 50-60 r / min to make a soft material. The solution amount is adjusted according to the state of the soft material, and the standard is that the soft material can be held together, lightly pressed to disperse, and the powder does not stick to the hand after being released. 5% (w / v) is a unit representing the concentration of the solution, where w represents weight and v represents volume, and 5% (w / v) means that there are 5 g of solute in every 100 mL of solution.

[0032] S402, the soft material is placed into a fluidized bed granulator, and the preheating inlet air is set to 70-75℃, the inlet air volume is 80-100 m³ / h, the atomization pressure is 0.2-0.3 MPa, and the liquid spraying speed is 5-8 mL / min. The granule temperature is monitored in real time during the granulation process to be within the range of 55-60℃, and after the granulation is completed, the granules are sieved through a 16-mesh sieve and dried in a hot air circulating drying box to a moisture content of ≤5% to obtain mixed granules.

[0033] S5, the mixed granules are put into a mixer, and the artificial bovine bile powder, nano realgar powder, glycyrrhizic acid powder, and ice powder treated in step S2 are added in sequence to obtain a bovine bile detoxification mixture. Specifically, the following steps are included: S501, the mixed granules are put into a double-cone rotary mixer, and the artificial bovine bile powder, nano realgar powder, and glycyrrhizic acid powder are added in sequence and mixed at a speed of 12-15 r / min for 15-20 minutes; S502, the ice powder after inclusion is added, and the mixing is continued for 10-15 minutes. After mixing, the content uniformity is detected to ensure that the RSD is ≤5%, and the bovine bile detoxification mixture is obtained.

[0034] S6, the bovine bile detoxification mixture is filled into capsules and subjected to quality detection to obtain the bovine bile detoxification capsules.

[0035] The bovine bile detoxification mixture is filled into selected capsules, and after filling is completed, the capsules are subjected to a sealing inspection, and capsules with powder leakage or poor sealing are removed. Through automatic visual detection equipment, capsules with surface damage, deformation, uneven color, and the like are removed, and after content determination and microbial limit test, the bovine bile detoxification capsules are packaged.

[0036] The application adjusts the component proportion and introduces new components in the formula aspect, enhances the comprehensive curative effects of heat-clearing and detoxifying, anti-inflammatory and detumescence, antibacterial and antiviral, and significantly reduces the potential safety risk through the technical improvement and reasonable compatibility of toxic components; further expands the drug targeting for various diseases. The modern extraction, granulation and mixing technology is adopted in the preparation method, greatly improves the extraction rate and utilization rate of effective components of medicinal materials, ensures the uniform quality and uniform dispersion of components of granules through precise process control, effectively improves the dissolution rate and bioavailability of the drug; the special treatment process of volatile components greatly reduces the component loss and guarantees the stability of product quality. Finally, the efficacy of Niuhuang Jiedu Capsules can be enhanced and the toxicity risk can be reduced, and the production efficiency and quality stability can be improved.

[0037] It should be noted that in this document, the terms "comprising", "including", or any other variant thereof are intended to cover non-exclusive inclusions, so that a process, device, article or method including a series of elements not only includes those elements, but also includes other elements not explicitly listed, or inherent to such a process, device, article or method. Without more limitations, the element defined by the statement "including a" does not exclude the presence of other identical elements in the process, device, article or method including the element.

[0038] The above only describes the preferred embodiments of the application, and does not limit the patent scope of the application, and any equivalent structure or equivalent process transformation using the content of the specification and drawings, or direct or indirect application in other related technical fields, are also included in the patent protection scope of the application.

Claims

1. A formula of Niuhuang Jiedu Capsule, characterized in that: Includes the following components: Artificial bezoar 4.5~5.5% Nano realgar 3.5~4.5% Gypsum 23~26% Rhubarb 19~21% Scutellaria baicalensis 17-19% Platycodon grandiflorum 10~12% Borneol 2.5~3% Licorice 5-6% Honeysuckle extract 12~14% Forsythia suspensa extract 9~13% 8~10% of edema yedoensis extract Isatis root extract 7~9% Burdock fruit extract 6~8% Glycyrrhizic acid 1~5% β-cyclodextrin 8~9% Povidone K30 2~2.5% Pharmaceutical grade starch residue The above percentages are weight percentages, and the sum of the components constitutes 100% of the total weight percentage of the Niuhuang Jiedu Capsule formula.

2. A method for preparing Niuhuang Jiedu Capsule, characterized in that: Based on the formula of Niuhuang Jiedu Capsule according to claim 1, the preparation method specifically comprises: S1, according to the formula of described Niuhuang Jiedu Capsule, accurately weigh each component of setting weight percentage; S2, crushing and screening the combination of artificial bezoar, nano-realgar, and glycyrrhizic acid, crushing and screening the combination of rhubarb, scutellaria, platycodon, and licorice, ultrasonically extracting the gypsum, dissolving the borneol, and crushing the honeysuckle extract, forsythia extract, Viola yedoensis extract, isatis root extract, and arctium fruit extract; S3, mixing the gypsum powder, rhubarb powder, scutellaria powder, platycodon powder, licorice powder, honeysuckle extract powder, forsythia extract powder, Viola yedoensis extract powder, isatis root extract powder, and burdock fruit extract powder after the treatment in step S2 in a mixer for 30 to 40 minutes to obtain a premixed powder; S4. Prepare a 5% (w / v) povidone K30 ethanol solution, slowly spray the solution on the premixed powder and stir to form a soft material that can be held in the hand, and use the soft material to granulate using a granulator to obtain mixed granules; S5, the mixed particles are put into a mixer, and the artificial bezoar powder, nano realgar powder, glycyrrhizic acid powder and borneol powder after step S2 are added in sequence to obtain a bezoar detoxification mixture; S6, filling the Niuhuang Jiedu mixture into capsules, and performing quality inspection to obtain the Niuhuang Jiedu capsules.

3. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that, In step S2, the combination of artificial bezoar, nano-realgar and glycyrrhizic acid is subjected to a crushing and screening process, specifically: The artificial bezoar, nano-realgar and glycyrrhizic acid are respectively pulverized by a jet mill, wherein the artificial bezoar and glycyrrhizic acid are passed through a 100-mesh sieve, and the nano-realgar is monitored by a laser particle size analyzer to ensure that more than 90% of the particles are less than 100 nm in size, thereby obtaining artificial bezoar powder, nano-realgar powder and glycyrrhizic acid powder.

4. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that In the step S2, the combination of rhubarb, scutellaria, platycodon and liquorice is subjected to another crushing and screening process, specifically comprising: The rhubarb, scutellaria, platycodon and liquorice are pulverized by adopting a low-temperature pulverization technology with -20°C liquid nitrogen precooling, and the pulverized rhubarb, scutellaria, platycodon and liquorice are sieved with 80 meshes to obtain rhubarb powder, scutellaria powder, platycodon powder and liquorice powder.

5. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that, In the step S2, the gypsum is subjected to ultrasonic extraction, which specifically includes: The gypsum is placed in an ultrasonic extraction tank, and 8 to 10 times the amount of purified water is added to perform ultrasonic extraction twice, each time for 40 to 50 minutes. The extract is filtered through a plate and frame filter press, and the filtrate is concentrated under reduced pressure in a vacuum concentration tank to a relative density of 1.2 to 1.3, and then dried. After drying, the gypsum is crushed and passed through an 80-mesh sieve to obtain gypsum powder.

6. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that, In step S2, the borneol is dissolved, specifically comprising: The borneol and β-cyclodextrin are prepared in a ratio of 1:3, the β-cyclodextrin is first added to 60-70°C purified water, stirred to dissolve, and then the borneol is added, and the mixture is transferred to an ultrasonic inclusion reactor for inclusion for 1-1.5 hours. The obtained inclusion compound is dried in a vacuum drying oven and then crushed through an 80-mesh sieve to obtain borneol powder; wherein the weight of the added purified water is 8-10 times that of the β-cyclodextrin.

7. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that, In the step S2, the honeysuckle extract, forsythia suspensa extract, Viola yedoensis extract, isatis root extract, and arctium lappa fruit extract are pulverized, specifically comprising: The honeysuckle extract, forsythia extract, viola yedoensis extract, isatis root extract, and burdock fruit extract were tested for effective ingredient content, and were crushed to 100 mesh using an ultrafine grinder. After crushing, a particle size distribution test was performed to ensure that the D90 particle size was ≤150 μm to obtain honeysuckle extract powder, forsythia extract powder, viola yedoensis extract powder, isatis root extract powder, and burdock fruit extract powder.

8. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that, The step S4 specifically includes: S401. Prepare a 5% (w / v) povidone K30 ethanol solution with an ethanol concentration of 70%. Slowly spray the solution onto the premixed powder while stirring at a speed of 50-60 r / min to form a soft material. Adjust the amount of solution according to the state of the soft material, using the standard that the powder forms a ball when held by hand, falls apart when lightly pressed, and does not stick to the hand after releasing the hand; S402, placing the soft material into a fluidized bed granulator, and setting the preheated air intake to 70-75°C, the air intake volume to 80-100 m³ / h, the atomization pressure to 0.2-0.3 MPa, and the spray rate to 5-8 mL / min; during the granulation process, the granule temperature is monitored in real time within the range of 55-60°C, and after granulation is completed, the granules are sieved through a 16-mesh sieve and dried in a hot air circulation drying oven to a moisture content of ≤5% to obtain mixed granules.

9. The preparation method of Niuhuang Jiedu Capsule according to claim 2, characterized in that: The step S5 specifically includes: S501, the mixed particles are put into a double cone rotary mixer, and the artificial bezoar powder, nano realgar powder and glycyrrhizic acid powder are added in sequence, and mixed at a rotating speed of 12-15 r / min for 15-20 minutes; S502, adding the encapsulated borneol powder, continuing to mix for 10 to 15 minutes, and testing the content uniformity after mixing to obtain the bezoar detoxification mixture.

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