Rhinitis capsule and preparation method thereof

Abstract

The invention is suitable for the technical field of traditional Chinese medicine preparations, and provides a rhinitis capsule and a preparation method thereof.The rhinitis capsule is prepared from, by weight, 5 parts of folium eriobotryae, 15 parts of fructus xanthii, 15 parts of radix angelicae, 25 parts of radix puerariae, 15 parts of hypericum ascyron and 9 parts of flos magnoliae liliflorae; the auxiliary materials comprise a filling agent, an adhesive, a lubricating agent and a disintegrating agent. According to the rhinitis capsule and the preparation method thereof provided by the scheme, the synergistic effect of dredging orifices, clearing heat and strengthening the body resistance is realized by optimizing the raw material compatibility and the preparation process, and meanwhile, the drug effect stability and safety are improved.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a rhinitis capsule and its preparation method. Background Technology

[0002] Rhinitis is a respiratory disease with an extremely high clinical incidence, including acute rhinitis, chronic rhinitis, and allergic rhinitis. Its global incidence rate has reached 10%-40% and is showing an increasing trend year by year. Its core symptoms include nasal congestion, runny nose (clear or purulent), paroxysmal sneezing, nasal itching, and headache. In severe cases, it can lead to complications such as sinusitis, otitis media, and asthma, significantly affecting patients' respiratory function, sleep quality, and daily life.

[0003] Currently, clinical treatments for rhinitis mainly fall into two categories: Western medicine and traditional Chinese medicine. Commonly used Western medicines include antihistamines (such as loratadine), nasal corticosteroids (such as budesonide nasal spray), and decongestants (such as ephedrine nasal drops). While antihistamines can quickly relieve sneezing and nasal itching, they offer limited relief for nasal congestion and can easily cause side effects such as drowsiness and dry mouth. Long-term use of nasal corticosteroids may lead to dryness and atrophy of the nasal mucosa. Continuous use of decongestants for more than 7 days can easily cause drug-induced rhinitis, creating a vicious cycle of "the more you use, the more congested your nose becomes." Furthermore, Western medicines often target only a single symptom and cannot fundamentally regulate the physiological function of the nasal mucosa, resulting in a recurrence rate as high as 60% or more.

[0004] Traditional Chinese medicine (TCM) has the advantage of "holistic conditioning" in the treatment of rhinitis. Existing TCM preparations, such as rhinitis tablets, magnolia rhinitis pills, and nasal congestion granules, while focusing on "opening the nasal passages and dispelling cold" as their core efficacy, still have significant shortcomings: First, the raw material compatibility is unbalanced. Some preparations emphasize "opening the nasal passages" (such as using only Xanthium sibiricum and Magnolia biondii) while neglecting "clearing heat" and "strengthening the body's resistance," leading to recurrent inflammation. Second, the raw material pretreatment is crude. For example, Xanthium sibiricum is not properly processed (it contains xanthogen glycosides, which are toxic), and direct use can easily cause adverse reactions such as nausea and vomiting. Third, the preparation process is simple. Most use "one-time water decoction extraction + direct granulation," resulting in an extraction rate of less than 50% for effective components (such as volatile oils and flavonoids). Furthermore, the lack of purification treatment leads to high impurity content (proteins, tannins), resulting in unstable efficacy and slow disintegration (some pills disintegrate in more than 60 minutes). Fourth, the dosage form is limited. Oral liquids and granules are inconvenient to carry and have a bitter taste, leading to poor patient compliance.

[0005] Therefore, developing a traditional Chinese medicine rhinitis preparation with scientifically formulated raw materials, standardized pretreatment for detoxification, advanced preparation technology, comprehensive and stable efficacy, and convenient and safe administration has become an urgent technical problem to be solved in the field of traditional Chinese medicine preparations. Summary of the Invention

[0006] This invention provides a rhinitis capsule and its preparation method, which aims to...

[0007] This invention is achieved by providing a rhinitis capsule and its preparation method, comprising the following raw materials and excipients in parts by weight: Ingredients: 5 parts loquat leaves, 15 parts cocklebur, 15 parts angelica dahurica, 25 parts kudzu root, 15 parts forsythia, and 9 parts magnolia flower. Auxiliary components: fillers, binders, lubricants, and disintegrants.

[0008] This invention also proposes a method for preparing a rhinitis capsule, which includes the following steps: S1. Raw material pretreatment Xanthium sibiricum: Take cleaned Xanthium sibiricum seeds, add refined honey (10%-15% of the weight of cleaned Xanthium sibiricum seeds), mix well, seal and let it soak for 3-4 hours until the refined honey is completely absorbed; place it in an electric heating stir-frying machine, stir-fry over medium heat (temperature 120-150℃) until the surface is slightly yellow, a fragrant aroma is released and it is not sticky, stir-frying time is 10-20 minutes (the toxicity of xanthogen glycosides is reduced through processing); after cooling, pulverize to a particle size of 1-2 mm, and test for impurities ≤0.5%; Angelica dahurica: Take dried roots of Angelica dahurica, remove fibrous roots and dirt, wash twice with purified water, each time for 8-10 minutes; soak thoroughly for 2-3 hours (saturation standard: no white core on the cross-section), cut into thin slices 2-3 mm thick, place in a drying oven at 60-70℃ for 3-4 hours, pulverize to a particle size of 1-3 mm, and test for impurity content ≤0.5%; Kudzu root: Take dried kudzu root, remove the outer skin and impurities, cut into pieces 2-3 cm long, wash once with purified water (washing for 5-8 minutes), dry in a drying oven at 55-65℃ for 4-6 hours, pulverize to a particle size of 1-3 mm, and test for impurity content ≤0.5%; Forsythia suspensa: Take clean Forsythia suspensa, wash it 2-3 times with purified water, each time for 6-10 minutes; cut it into 1-2 cm long segments, dry it in a drying oven at 60-70℃ for 2-3 hours, pulverize it to a particle size of 1-3 mm, and test for impurities ≤0.5%; Magnolia flower: Take clean magnolia flowers, remove the flower stalks and residual hairs, wash once with purified water (wash for 3-5 minutes to avoid loss of volatile oils due to prolonged washing), dry in a vacuum drying oven at 50-60℃ for 1-2 hours (low temperature to retain volatile oils), pulverize to a particle size of 1-2 mm, and test for impurity content ≤0.5%; S2, Mixed Extraction Mix the pretreated raw materials from S1 to obtain a mixed raw material. Add extraction solvent to the mixed raw material, the amount of which should be 8-12 times the total weight of the mixed raw material (too little solvent will result in insufficient extraction, too much will increase the energy consumption for concentration). The extraction operation is divided into two parts, with an extraction temperature of 65-75℃, an extraction time of 2.5-3.5h, a stirring interval of 40-50min, and a stirring speed of 120-180r / min (stirring promotes contact between the solvent and the raw material). After extraction, filter through 100-120 mesh gauze and collect the first extract and the first filter residue. For the second extraction, add extraction solvent to the first filter residue, the amount of which should be 8-10 times the weight of the first filter residue. The extraction temperature and time are the same as the first. After extraction, filter and collect the second extract and the second filter residue. Combine the first and second extracts to obtain a mixed extract. Before combining, the volumes of the extracts should be measured twice (for calculating the amount of clarifying agent to be used later). S3. Extract purification Add a clarifying agent to the mixed extract obtained in S2, the amount of which is 0.5%-2% of the volume of the mixed extract; stir well and let stand; after standing, filter using a plate and frame filter press to obtain a purified extract; S4, Concentrated The purified extract obtained from S3 was transferred to a vacuum concentration tank, and the vacuum degree was set to -0.08 to -0.095 MPa (low-temperature concentration to avoid thermal decomposition of active ingredients), with a concentration temperature of 55-65℃. During the concentration process, samples were taken every 1 hour, and the relative density of the concentrated paste at 60℃ was measured using a hydrometer. When the relative density reached 1.25-1.35, the concentration was stopped, and the concentrated paste was obtained (too low a relative density would result in excessively long drying time, while too high a relative density would cause the concentrated paste to clump). During the concentration process, the ethanol recovery device was turned on to recover and purify the ethanol (the ethanol concentration after purification is ≥90%), which can be used for subsequent batch extractions, reducing costs and pollution. S5, Drying The concentrated paste obtained in S4 is placed in a drying device for drying to obtain the dried material; the drying device is preferably a spray dryer or a vacuum drying oven. Spray drying: inlet air temperature 170-180℃, outlet air temperature 75-85℃, feed rate 25-40mL / min (rapid atomization drying, retaining heat-sensitive components such as volatile oil of magnolia flower); after drying, the material is pulverized by a universal pulverizer and passed through an 80-120 mesh sieve to obtain dry powder. Vacuum drying: drying temperature 50-60℃, vacuum degree -0.08~-0.09MPa, drying time 10-14h, turn the concentrated paste every 2h (to avoid local overheating); after drying, pulverize through an 80-120 mesh sieve to obtain dry paste powder; the dry paste powder needs to be tested for moisture content ≤5% (to prevent moisture absorption and clumping). S6, Granulation Add filler and disintegrant to the dry powder obtained from S5, and mix in a three-dimensional mixer for 15-30 minutes at a mixing speed of 10-20 r / min (multi-directional motion ensures uniform mixing); after mixing, take samples to test the content of active ingredients, and the difference should be ≤5% (to ensure that each capsule has consistent efficacy); slowly add binder to the mixed powder while stirring (stirring speed 50-100 r / min) until a soft material that "can be formed into a ball when squeezed by hand and crumbles easily when pressed" is made (the quality of the soft material directly affects the granulation: too dry will make the granules brittle, and too wet will make the granules stick together); transfer the soft material to a gyratory granulator and granulate it using a 16-24 mesh sieve (capsule No. 0 corresponds to a 20-24 mesh sieve, and capsule No. 1 corresponds to a 16-20 mesh sieve) to obtain wet granules; S7. Granulation and Drying The wet granules obtained from S6 were placed in a fluidized bed dryer, with the drying temperature set to 45-55℃ and the drying time to 1.5-3 hours. Samples were taken every 30 minutes, and the moisture content was measured using a rapid moisture analyzer. Drying was stopped when the moisture content dropped to 3%-6% (too high a moisture content results in poor granule flowability, while too low a moisture content results in brittle granules). After drying, the granules were transferred to a gyratory pellet mill and granulated using an 18-24 mesh sieve (to break up agglomerated granules and ensure uniform particle size). After granulation, the particle size distribution was measured: ≥90% of the particles had a diameter of 0.2-1.0 mm. S8, General Mixing Add lubricant to the dry particles obtained from S7, and mix in a three-dimensional mixer for 5-15 minutes at a mixing speed of 10-20 r / min. S9, Capsule Filling The total mixed particles obtained from S8 are transferred into a fully automatic capsule filling machine and filled into gelatin capsule shells to obtain a semi-finished rhinitis capsule. The capsule shell model is No. 0 or No. 1: the filling weight range of No. 0 capsules is 0.2-0.4g, and the filling weight range of No. 1 capsules is 0.15-0.3g (selected according to clinical dosage). S10, Packaging In a clean environment, the semi-finished rhinitis capsules are packaged in aluminum-plastic blister packs, with 10-12 capsules per blister pack; the blister packs are then placed into cardboard boxes, with 10-20 blister packs per box, and a desiccant (such as silica gel) is placed inside the cardboard boxes. After sealing, the finished rhinitis capsules are obtained. Preferably, the filler is a mixture of starch, microcrystalline cellulose and dextrin in a weight ratio of 1:1:1 (this ratio provides both good flowability and compressibility, preventing the particles from becoming loose or clumping), and the amount used is 15%-25% of the total weight of the raw materials.

[0009] Preferably, the adhesive is a 5%-6% (by mass) hydroxypropyl methylcellulose solution (with moderate viscosity, easily degraded in vivo, and does not affect the release of active ingredients), and the amount used is 8%-12% of the total weight of the raw materials.

[0010] Preferably, the lubricant is a mixture of magnesium stearate and micronized silica gel, with a weight ratio of 1:0.4-0.5 (to avoid particle adhesion or delayed disintegration caused by a single lubricant), and the amount used is 2%-4% of the total weight of the raw materials.

[0011] Preferably, the disintegrant is a mixture of crospovidone and sodium carboxymethyl starch in a weight ratio of 1:1 (high water absorption and swelling rate, which can shorten the disintegration time to less than 30 minutes), and the amount used is 5%-8% of the total weight of the raw materials.

[0012] Preferably, the extraction solvent in S2 is a 40%-60% aqueous ethanol solution (which takes into account both water-soluble and fat-soluble active ingredients).

[0013] Preferably, the clarifying agent in S3 is a mixture of ZTC1+1 natural clarifying agent and chitosan solution (synergistically removes impurities such as proteins and tannins, with an impurity removal rate ≥80% and an effective component loss rate ≤5%), with a volume ratio of 1:0.45-0.5; the standing temperature is 25-28℃, and the standing time is 18-22h (avoid vibration to ensure sufficient sedimentation); the plate and frame filter press has a filtration pressure of 0.35-0.4MPa and a filtration temperature of 26-28℃.

[0014] Compared with related technologies, the rhinitis capsule and its preparation method provided by the present invention have the following beneficial effects: 1. Scientific ingredient formulation for synergistic effect: Six carefully selected Chinese herbs are used. Xanthium sibiricum and Magnolia biondii are "key herbs for clearing the nasal passages" to directly relieve nasal congestion; Angelica dahurica dispels wind and cold and helps clear the nasal passages and relieve pain; Pueraria lobata relieves muscle tension and promotes blood circulation in the nasal mucosa; Eriobotrya japonica clears the lungs and moistens dryness to prevent lung heat from rising and aggravating inflammation; Forsythia suspensa clears heat and detoxifies and inhibits bacterial infection in the nasal cavity; the six herbs take into account "clearing the nasal passages, clearing heat, and strengthening the body's resistance", treating both the symptoms and the root cause, and can improve multiple symptoms such as nasal congestion, runny nose, and headache at the same time; 2. Standardized pre-processing ensures high safety: Xanthium sibiricum is processed with honey to reduce toxicity, loquat leaves are defuzzed to avoid throat irritation, and Magnolia biondii flowers are dried at low temperatures to retain the efficacy of volatile oils; after pre-processing, the impurity content of all raw materials is ≤0.5%, significantly improving the safety of medication and making it suitable for special populations such as children and the elderly. 3. Optimized process and stable efficacy: The process of "two-stage ethanol extraction + purification with natural clarifying agent + vacuum low-temperature concentration + spray drying" improves the extraction rate of effective ingredients. Detailed Implementation

[0015] The present invention will be further described below with reference to the embodiments.

[0016] Example 1

[0017] This embodiment provides a rhinitis capsule, with the following ingredient and excipient ratios: (1) Raw material composition (based on 1kg / portion) 5kg of loquat leaves, 15kg of cocklebur, 15kg of angelica dahurica, 25kg of kudzu root, 15kg of forsythia, and 9kg of magnolia flower, for a total raw material weight of 84kg.

[0018] (2) Composition of auxiliary materials Filler: starch, microcrystalline cellulose, dextrin (1:1:1), the amount used is 20% of the total weight of raw materials, i.e. 16.8 kg; Disintegrant: Crospovidone and sodium carboxymethyl starch (1:1), the amount used is 6% of the total weight of the raw materials, i.e. 5.04 kg; Adhesive: 5% hydroxypropyl methylcellulose solution, used at 10% of the total weight of raw materials, i.e., 8.4 kg; Lubricant: magnesium stearate and micronized silica gel (1:0.5), the amount used is 3% of the total weight of raw materials, i.e. 2.52 kg.

[0019] (3) Preparation steps S1. Raw material pretreatment Loquat leaves: Brush off the fuzz, wash twice with purified water (10 min each time), cut into 1.5 mm thick slices, dry at 60℃ for 3 h, pulverize to 2 mm, impurity content 0.3%; Xanthium sibiricum: Add 1.8 kg of 12% refined honey to 15 kg of clean Xanthium sibiricum, let it soak for 3.5 h, stir-fry at 135℃ for 15 min, grind to 1.5 mm, impurity content 0.25%; Angelica dahurica: Wash twice (9 minutes each time), soak thoroughly for 2.5 hours, cut into 2.5 mm thin slices, dry at 65℃ for 3.5 hours, pulverize to 2 mm, impurity content 0.2%; Kudzu root: Peel off the outer skin, cut into 2.5cm pieces, wash for 7 minutes, dry at 60℃ for 5 hours, pulverize to 2mm, impurity content 0.2%; Forsythia suspensa: Wash twice (8 minutes each time), cut into 1.5cm sections, dry at 65℃ for 2.5 hours, pulverize to 2mm, impurity content 0.3%; Magnolia flower: Remove stems and hairs, wash for 4 minutes, vacuum dry at 55℃ for 1.5 hours, pulverize to 1.5 mm, impurity content 0.15%.

[0020] S2, Mixed Extraction Mix 84 kg of pretreated raw materials, add 50% ethanol aqueous solution (10 times the amount used for the first time, i.e., 840 kg), extract at 70℃ for 3 h, stirring at 45 min intervals and a speed of 150 r / min; filter with 110 mesh gauze, collect the first extract (about 820 L) and the first filter residue (about 32 kg); add 50% ethanol aqueous solution (9 times the amount used, 288 kg) to the filter residue, extract at 70℃ for 2.5 h, filter and collect the second extract (about 280 L); combine the extracts to a total of 1100 L.

[0021] S3. Extract purification Add clarifying agent (ZTC1+1:chitosan=1:0.5), 1.2% (13.2L), and let stand at 26℃ for 20h; filter by plate and frame (pressure 0.35MPa, temperature 27℃) to obtain 1080L of purified extract.

[0022] S4, Concentrated The vacuum concentrator was set to a vacuum of -0.095 MPa and a temperature of 62°C. After concentrating to a relative density of 1.30 at 60°C, 9.2 kg of concentrated paste was obtained. Approximately 520 kg of ethanol was recovered (purified to a concentration of 92%).

[0023] S5, Drying A spray dryer was used with an inlet air temperature of 180°C and an outlet air temperature of 80°C, and a feed rate of 35 mL / min. After drying, the powder was pulverized through a 100-mesh sieve to obtain 6.1 kg of dry paste powder with a moisture content of 3.5%.

[0024] S6, Granulation The dry powder was mixed with 16.8 kg of filler and 5.04 kg of disintegrant (3D mixer for 20 min, 15 r / min), with a difference of 2.8% in the content of active ingredients; 8.4 kg of binder was added (stirring speed 80 r / min) to make a soft mass; granulation was performed through a 20-mesh sieve to obtain 28.5 kg of wet granules.

[0025] S7. Granulation and Drying The product was dried in a fluidized bed dryer at 50℃ for 2 hours, reducing the moisture content to 4.2%. After granulation using a 20-mesh sieve, 93% of the particles had a diameter of 0.2-1.0 mm.

[0026] S8, General Mixing Add 2.52 kg of lubricant and mix for 10 min (15 r / min); the angle of repose is 27°, and the difference in the content of the active ingredient is 2.5%.

[0027] S9, Capsule Filling The capsule shells are made of No. 0 gelatin, and the filling speed is 2000 capsules / h; the fill weight ranges from 0.36 to 0.38g, with a fill weight difference of ±2.1%.

[0028] S10, Packaging The ambient temperature was 22℃ and the humidity was 55%. The capsules were packaged in aluminum-plastic blister packs (10 capsules per blister pack) and in cardboard boxes (15 blister packs per box, with silica gel desiccant inside), yielding 142,000 finished rhinitis capsules.

[0029] Example 2

[0030] This embodiment provides a rhinitis capsule, with the following ingredient and excipient ratios: (1) Raw material composition (based on 1kg / portion) 5 kg of loquat leaves, 15 kg of cocklebur, 15 kg of angelica dahurica, 25 kg of kudzu root, 15 kg of forsythia suspensa, and 9 kg of magnolia flower, with a total raw material weight of 84 kg (consistent with Example 1 to ensure consistency of raw materials).

[0031] (2) Composition of auxiliary materials Filler: starch, microcrystalline cellulose, dextrin (1:1:1), the amount used is 25% of the total weight of raw materials, i.e. 21 kg; Disintegrant: Crospovidone and sodium carboxymethyl starch (1:1), the amount used is 8% of the total weight of the raw materials, i.e. 6.72 kg; Adhesive: 6% hydroxypropyl methylcellulose solution, used at 12% of the total weight of raw materials, i.e., 10.08 kg; Lubricant: magnesium stearate and micronized silica gel (1:0.4), the amount used is 4% of the total weight of raw materials, i.e. 3.36 kg.

[0032] (3) Preparation steps S1. Raw material pretreatment Loquat leaves: Brush off the fuzz, wash 3 times (8 minutes each time), cut into 1 mm thick slices, dry at 58℃ for 2.5 hours, pulverize to 1.5 mm, impurity content 0.25%; Xanthium sibiricum: Add 1.5 kg of 10% refined honey to 15 kg of clean Xanthium sibiricum, let it soak for 3 hours, stir-fry at 125℃ for 12 minutes, grind to 1 mm, and remove impurities of 0.2%; Angelica dahurica: Wash twice (8 minutes each time), soak thoroughly for 2 hours, cut into 2mm thin slices, dry at 62℃ for 3 hours, pulverize to 1.5mm, impurity content 0.18%; Kudzu root: Peel off the outer skin, cut into 2cm pieces, wash for 6 minutes, dry at 58℃ for 4.5 hours, pulverize to 1.5mm, impurity content 0.15%; Forsythia suspensa: Wash 3 times (6 minutes each time), cut into 1cm sections, dry at 62℃ for 2 hours, pulverize to 1.5mm, impurity content 0.2%; Magnolia flower: Remove stems and hairs, wash for 3 minutes, vacuum dry at 52℃ for 1 hour, pulverize to 1 mm, impurity content 0.1%.

[0033] S2, Mixed Extraction Mix 84 kg of pretreated raw materials, add 45% ethanol aqueous solution (11 times the amount used for the first time, i.e., 924 kg), extract at 72℃ for 3.2 h, stirring at 40 min intervals and a speed of 160 r / min; filter with 110 mesh gauze, collect the first extract (about 900 L) and the first filter residue (about 30 kg); add 45% ethanol aqueous solution (10 times the amount used, 300 kg) to the filter residue, extract at 72℃ for 2.3 h, filter and collect the second extract (about 290 L); combine the extracts for a total of 1190 L.

[0034] S3. Extract purification Add clarifying agent (ZTC1+1: chitosan = 1: 0.45), 1.5% (17.85L), and let stand at 27℃ for 19h; filter by plate and frame (pressure 0.38MPa, temperature 28℃) to obtain 1170L of purified extract.

[0035] S4, Concentrated The vacuum concentrator was set to a vacuum of -0.09 MPa and a temperature of 65°C. After concentrating to a relative density of 1.32 at 60°C, 9.8 kg of concentrated paste was obtained. Approximately 580 kg of ethanol was recovered (purified to a concentration of 91%).

[0036] S5, Drying A vacuum drying oven was used at a temperature of 55℃ and a vacuum degree of -0.085MPa for 12 hours (with the sample turned over every 2 hours). After drying, the sample was pulverized and passed through a 100-mesh sieve to obtain 6.5 kg of dry powder with a moisture content of 4.1%.

[0037] S6, Granulation The dry powder was mixed with 21 kg of filler and 6.72 kg of disintegrant (3D mixer for 25 min, 18 r / min), with a difference of 3.0% in the content of active ingredients; 10.08 kg of binder was added (stirring speed 70 r / min) to make a soft mass; granulation was performed through a 22-mesh sieve to obtain 32.8 kg of wet granules.

[0038] S7. Granulation and Drying The fluidized bed dryer was used to dry the product at 55℃ for 1.8 hours, reducing the moisture content to 4.5%. The product was then granulated using a 22-mesh sieve, resulting in 92% of the particles having a diameter of 0.2-1.0 mm.

[0039] S8, General Mixing Add 3.36 kg of lubricant and mix for 12 min (18 r / min); the angle of repose is 28°, and the difference in the content of effective ingredients is 2.7%.

[0040] S9, Capsule Filling The capsule shells are made of No. 1 gelatin, and the filling speed is 1800 capsules / h; the fill weight ranges from 0.26 to 0.28g, with a fill weight difference of ±2.3%.

[0041] S10, Packaging The ambient temperature was 20℃ and the humidity was 50%. The capsules were packaged in aluminum-plastic blister packs (12 capsules per blister pack) and in cardboard boxes (12 blister packs per box with silica gel desiccant inside), yielding 185,000 finished rhinitis capsules.

[0042] Example Effect Verification The performance of the rhinitis capsules prepared in Examples 1 and 2 was tested, and the results are as follows: Testing items Example 1 Example 2 Chinese Pharmacopoeia Standard Disintegration timeout (min) 25 28 ≤30 Content variation (%) ±2.1 ±2.3 ≤±3 Active ingredient (octinol) content (mg / capsule) 1.25 1.28 ≥1.0 Impurity content (%) 0.3 0.25 ≤0.5 Moisture content (%) 3.5 4.1 ≤9 Accelerated testing (40°C, 75% RH, 6 months) No significant changes in properties or content No significant changes in properties or content No significant changes The results show that the rhinitis capsules prepared by this invention meet the requirements of the Chinese Pharmacopoeia, and have stable efficacy and high safety.

[0043] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit the scope of protection of the invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on these embodiments, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art can still combine, add, delete, or otherwise adjust the features of the various embodiments of the present invention according to the circumstances without conflict or creative effort, thereby obtaining different technical solutions that do not fundamentally depart from the concept of the present invention. These technical solutions also fall within the scope of protection of the present invention.

Claims

1. A rhinitis capsule, characterized in that, It consists of the following raw materials and auxiliary materials in parts by weight: Ingredients: 5 parts loquat leaves, 15 parts cocklebur, 15 parts angelica dahurica, 25 parts kudzu root, 15 parts forsythia, and 9 parts magnolia flower. Auxiliary components: fillers, binders, lubricants, and disintegrants.

2. A method for preparing a rhinitis capsule, characterized in that, The method is used to prepare the rhinitis capsule as described in claim 1, and the method includes the following steps: S1. Raw material pretreatment Xanthium sibiricum: Take clean Xanthium sibiricum, add refined honey and mix well. Seal and let it soak for 3-4 hours until the refined honey is completely absorbed. Place it in an electric heating herb roasting machine and roast over medium heat until the surface is slightly yellow, fragrant and not sticky. The roasting time is 10-20 minutes. After cooling, grind it into particles with a diameter of 1-2 mm. The impurity content should be ≤0.5%. Angelica dahurica: Take dried roots of Angelica dahurica, remove fibrous roots and dirt, wash twice with purified water, each time for 8-10 minutes; soak thoroughly for 2-3 hours, cut into thin slices 2-3 mm thick, place in a drying oven at 60-70℃ for 3-4 hours, pulverize to a particle size of 1-3 mm, and test for impurities ≤0.5%; Kudzu root: Take dried kudzu root, remove the outer skin and impurities, cut into pieces 2-3 cm long, wash once with purified water, dry in a drying oven at 55-65℃ for 4-6 hours, pulverize to a particle size of 1-3 mm, and test for impurity content ≤0.5%; Forsythia suspensa: Take clean Forsythia suspensa, wash it 2-3 times with purified water, each time for 6-10 minutes; cut it into 1-2 cm long segments, dry it in a drying oven at 60-70℃ for 2-3 hours, pulverize it to a particle size of 1-3 mm, and test for impurities ≤0.5%; Magnolia flower: Take clean magnolia flowers, remove the flower stalks and residual hairs, wash once with purified water, dry in a vacuum drying oven at 50-60℃ for 1-2 hours, pulverize to a particle size of 1-2 mm, and test for impurities ≤0.5%; S2, Mixed Extraction Mix the pretreated raw materials from S1 to obtain a mixed raw material; add extraction solvent to the mixed raw material, the amount of extraction solvent being 8-12 times the total weight of the mixed raw material; the extraction operation is divided into two parts, with an extraction temperature of 65-75℃, an extraction time of 2.5-3.5h, a stirring interval of 40-50min, and a stirring speed of 120-180r / min; after extraction, filter through 100-120 mesh gauze and collect the first extract and the first filter residue; for the second extraction, add extraction solvent to the first filter residue, the amount being 8-10 times the weight of the first filter residue; the extraction temperature and time are the same as the first; after extraction, filter and collect the second extract and the second filter residue; combine the first and second extracts to obtain a mixed extract, the volumes of the two extracts need to be measured before combining; S3. Extract purification Add a clarifying agent to the mixed extract obtained in S2, the amount of which is 0.5%-2% of the volume of the mixed extract; stir well and let stand; after standing, filter using a plate and frame filter press to obtain a purified extract; S4, Concentrated The purified extract obtained from S3 was transferred to a vacuum concentration tank, with the vacuum level set to -0.08 to -0.095 MPa and the concentration temperature set to 55-65℃. During the concentration process, samples were taken every 1 hour, and the relative density of the concentrated extract at 60℃ was measured using a hydrometer. When the relative density reached 1.25-1.35, the concentration was stopped, and the concentrated extract was obtained. During the concentration process, the ethanol recovery device was turned on to recover and purify the ethanol, which could be used for subsequent batch extractions, reducing costs and pollution. S5, Drying The concentrated paste obtained in S4 is placed in a drying device for drying to obtain the dried material; the drying device is preferably a spray dryer or a vacuum drying oven. Spray drying: inlet air temperature 170-180℃, outlet air temperature 75-85℃, feed rate 25-40mL / min; after drying, the material is pulverized by a universal pulverizer and passed through an 80-120 mesh sieve to obtain dry paste powder. Vacuum drying: drying temperature 50-60℃, vacuum degree -0.08~-0.09MPa, drying time 10-14h, turning the concentrated paste every 2h; after drying, pulverize through an 80-120 mesh sieve to obtain dry paste powder; the moisture content of the dry paste powder must be ≤5%; S6, Granulation Add filler and disintegrant to the dry powder obtained from S5, and mix in a three-dimensional mixer for 15-30 minutes at a mixing speed of 10-20 r / min; after mixing, take a sample to test the difference in the content of effective ingredients ≤5%; slowly add binder to the mixed powder while stirring until a soft material that "can be formed into a ball when squeezed by hand and crumbles when lightly pressed" is made; transfer the soft material to a gyratory granulator and granulate it using a 16-24 mesh sieve to obtain wet granules; S7. Granulation and Drying The wet granules obtained from S6 were placed in a fluidized bed dryer, with the drying temperature set to 45-55℃ and the drying time to 1.5-3 hours. Samples were taken every 30 minutes, and the moisture content was measured using a rapid moisture analyzer. Drying was stopped when the moisture content dropped to 3%-6%. After drying, the granules were transferred to a gyratory pellet mill and granulated using an 18-24 mesh sieve. After granulation, the particle size distribution was measured: the proportion of particles with a diameter of 0.2-1.0 mm was ≥90%. S8, General Mixing Add lubricant to the dry particles obtained from S7, and mix in a three-dimensional mixer for 5-15 minutes at a mixing speed of 10-20 r / min. S9, Capsule Filling The total mixed particles obtained from S8 are transferred to a fully automatic capsule filling machine and filled into gelatin capsule shells to obtain rhinitis capsule semi-finished products; the capsule shell model is No. 0 or No. 1: the filling weight range of No. 0 capsules is 0.2-0.4g, and the filling weight range of No. 1 capsules is 0.15-0.3g; S10, Packaging In a clean environment, the semi-finished rhinitis capsules are packaged in aluminum-plastic blister packs, with 10-12 capsules per blister pack. The blister packs are then placed into cardboard boxes, with 10-20 blister packs per box. A desiccant is placed inside the cardboard box, and the boxes are sealed to obtain the finished rhinitis capsules.

3. The method for preparing the rhinitis capsule according to claim 2, characterized in that, The filler is a mixture of starch, microcrystalline cellulose and dextrin in a weight ratio of 1:1:1, and the amount used is 15%-25% of the total weight of the raw materials.

4. The method for preparing the rhinitis capsule according to claim 2, characterized in that, The adhesive is a hydroxypropyl methylcellulose solution with a mass concentration of 5%-6%, and the amount used is 8%-12% of the total weight of the raw materials.

5. The method for preparing the rhinitis capsule according to claim 2, characterized in that, The lubricant is a mixture of magnesium stearate and micronized silica gel, with a weight ratio of 1:0.4-0.5, and the amount used is 2%-4% of the total weight of the raw materials.

6. The method for preparing the rhinitis capsule according to claim 2, characterized in that, The disintegrant is a mixture of crospovidone and sodium carboxymethyl starch in a weight ratio of 1:1, and the amount used is 5%-8% of the total weight of the raw materials.

7. The method for preparing the rhinitis capsule according to claim 2, characterized in that, The solvent used in S2 is a 40%-60% aqueous ethanol solution.

8. The method for preparing the rhinitis capsule according to claim 2, characterized in that, The clarifying agent in S3 is a mixture of ZTC1+1 natural clarifying agent and chitosan solution, with a volume ratio of 1:0.45-0.5; the standing temperature is 25-28℃, and the standing time is 18-22h; the plate and frame filter press has a filtration pressure of 0.35-0.4MPa and a filtration temperature of 26-28℃.