Externally applied medicine bag for hyperplasia and swelling of cervical and lumbar joint vertebrae and preparation method of externally applied medicine bag

Abstract

The external application medicine bag is prepared from the following raw materials in parts by weight: 6 to 8g of flos carthami, 5 to 7g of ground beetles, 7 to 9g of leeches, 5 to 6g of akebia stems, 8 to 10g of herba taxilli, 6 to 8g of gadflies, 5 to 7g of sappan wood, 8 to 10g of radix salviae miltiorrhizae, 6 to 9g of radix paeoniae rubra, 5 to 7g of native copper, 7 to 9g of catechu, 8 to 10g of fossil fragments, 6 to 8g of oysters and 7 to 9g of rhizoma gastrodiae. The traditional Chinese medicine bag has the beneficial effects that the traditional Chinese medicine bag has comprehensive conditioning effects of dredging meridians and collaterals, removing stasis and blocking and reducing blood viscosity, can effectively prevent cardiovascular and cerebrovascular diseases through long-term local external application according to a treatment course, and has an auxiliary treatment effect on various common diseases such as hypertension, insomnia, anxiety, cerebral infarction and lumbar disc herniation; it is worth mentioning that by means of the three-dimensional structural design of the paper folding tea bag, the dissolution efficiency of effective components is remarkably improved, meanwhile, the packaging size is reduced by 60%, and the tea bag is more environmentally friendly and portable; meanwhile, through a standardized preparation process, the use convenience and safety can be taken into account on the basis of ensuring stable release of the drug effect.

Description

Technical Field

[0001] This invention relates to the field of external application of traditional Chinese medicine, specifically to external application medicine packs for cervical and lumbar vertebral hyperplasia and swelling, and their preparation methods. Background Technology

[0002] Cervical and lumbar vertebral joint hyperplasia and swelling are common and frequently occurring diseases among middle-aged and elderly people. With the acceleration of population aging and changes in modern lifestyles, the incidence rate is showing an upward trend year by year. These diseases are mostly caused by long-term strain, improper posture, and aging, which leads to poor blood circulation, meridian blockage, and malnutrition of muscles and bones.

[0003] Currently, clinical treatments for cervical and lumbar spondylosis mainly include oral medications, physical therapy, and surgical intervention. While oral anti-inflammatory drugs can temporarily relieve symptoms, long-term use can easily lead to gastrointestinal damage. Local injections of glucocorticoids are effective, but carry risks such as tissue atrophy and osteoporosis. Surgical treatment is highly invasive, expensive, and has a long recovery period. In comparison, traditional Chinese medicine external treatments have unique advantages.

[0004] However, existing traditional Chinese medicine external application preparations still have many shortcomings: First, the drug formulations are mostly limited to the single effects of promoting blood circulation and removing blood stasis or dispelling wind and dampness, lacking the overall regulation of the complex pathogenesis of the cervical and lumbar spine; Second, the particle size of traditional external application powders is uneven, the dissolution rate of effective ingredients is low, and the transdermal absorption effect is poor. Therefore, this application proposes an external application medicine pack for cervical and lumbar spine hyperplasia and swelling. Summary of the Invention

[0005] The purpose of this invention is to provide a topical medicated pack for cervical and lumbar vertebral hyperplasia and swelling, and its preparation method, so as to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a topical medicated pack for cervical and lumbar spondylosis and swelling, made from the following raw materials in parts by weight: safflower 6-8g, ground beetle 5-7g, leech 7-9g, akebia stem 5-6g, mulberry mistletoe 8-10g, horsefly 6-8g, sappanwood 5-7g, salvia miltiorrhiza 8-10g, red peony root 6-9g, natural copper 5-7g, catechu 7-9g, dragon bone 8-10g, oyster shell 6-8g, gastrodia elata 7-9g, dragon's blood 5-7g, actingaria root bark 6-8g, gentian root 5-7g, forsythia 8-10g, chicken bone grass 6-9g, artemisia capillaris 5-8g, apocynum venetum 7-9g, rhubarb 8-10g, prepared rehmannia root 6-8g, schisandra fruit 5-7g, frankincense 7-9g, myrrh 6-8g, and chuanxiong rhizome 8-10g.

[0007] Preferably, the akebia is Aristolochia manshuriensis or Aristolochia debilis.

[0008] Preferably, the horsefly is a dried horsefly or yellow horsefly.

[0009] Preferably, the natural copper is calcined natural copper with a particle size ≤0.5mm.

[0010] The preparation method of a topical medicated pack for cervical and lumbar vertebral hyperplasia and swelling includes the following steps: S1. Herbal Powdering: After washing the raw medicinal materials, dry them until the moisture content is ≤8%, then grind them into fine powder and pass them through a 200-mesh sieve; S2. Sterilization: Sterilize the powder by ultraviolet irradiation or high-temperature steam; S3. Precise Weighing: Weigh each herbal powder according to the formula ratio using an electronic balance, with the error controlled within ±0.1g; S4. Mixing and Homogenizing: Put the weighed powder into a three-dimensional motion mixer and mix until the color is uniform; S5. Powder Purification: Pass the mixed powder through a 300-mesh sieve again to remove fibers and impurities; S6. Drying and Dehydration: Spread the powder evenly on a tray and place it in an oven to dehydrate until the moisture content is ≤5%; S7. Packaging and Bagging: Divide the powder into 30-50g packages and pack them into non-woven bags, then heat-seal them.

[0011] Preferably, the drying temperature in S1 is 50-60℃ and the drying time is 2 hours.

[0012] Preferably, the ultraviolet irradiation intensity in S2 is 0.5-1.0 W / m², and the irradiation time is 30-60 minutes; The high-temperature steam sterilization temperature is 100-121℃, and the time is 20-40 minutes.

[0013] Preferably, the mixing speed in S4 is 20-40 rpm and the mixing time is 30-60 minutes.

[0014] Preferably, the drying temperature in step S6 is 55-65℃ and the drying time is 1-2 hours.

[0015] Preferably, the nonwoven bag in S7 is a breathable medical nonwoven fabric with a sealing temperature of 120-140℃.

[0016] Compared with the prior art, the beneficial effects of the present invention are: the herbal pack has the comprehensive conditioning effects of clearing the meridians, removing blood stasis and reducing blood viscosity. Long-term local external application according to the course of treatment can effectively prevent cardiovascular and cerebrovascular diseases, and has an auxiliary therapeutic effect on a variety of common diseases such as hypertension, insomnia, anxiety, cerebral infarction, and lumbar disc herniation. It is worth mentioning that the "origami tea bag" three-dimensional structure design not only significantly improves the dissolution efficiency of the active ingredients, but also reduces the packaging volume by 60%, making it more environmentally friendly and portable. Meanwhile, through standardized preparation processes, it is possible to ensure stable drug release while also taking into account ease of use and safety. Detailed Implementation

[0017] To address the problems of existing traditional Chinese medicine external application preparations being limited to the single effects of promoting blood circulation and removing blood stasis or dispelling wind and dampness, lacking overall regulation of the complex pathogenesis of cervical and lumbar spine diseases, and having uneven drug particle size, low dissolution rate of effective ingredients, and poor transdermal absorption.

[0018] This invention provides a technical solution: a topical medicated pack for cervical and lumbar vertebral hyperplasia and swelling, made from the following raw materials in parts by weight: safflower 6-8g, ground beetle 5-7g, leech 7-9g, akebia stem 5-6g, mulberry mistletoe 8-10g, horsefly 6-8g, sappanwood 5-7g, salvia miltiorrhiza 8-10g, red peony root 6-9g, natural copper 5-7g, catechu 7-9g, dragon bone 8-10g, oyster shell 6-8g, gastrodia elata 7-9g, dragon's blood 5-7g, actingaria root bark 6-8g, gentian root 5-7g, forsythia 8-10g, chicken bone grass 6-9g, artemisia capillaris 5-8g, apocynum venetum 7-9g, rhubarb 8-10g, prepared rehmannia root 6-8g, schisandra fruit 5-7g, frankincense 7-9g, myrrh 6-8g, and chuanxiong rhizome 8-10g.

[0019] Example 1: Ingredient ratio: 6g safflower, 5g ground beetle, 7g leech, 5g akebia stem, 8g mulberry mistletoe, 6g horsefly, 5g sappanwood, 8g salvia miltiorrhiza, 6g red peony root, 5g natural copper, 7g catechu, 8g dragon bone, 6g oyster shell, 7g gastrodia elata, 5g dragon's blood, 6g vine root bark, 5g gentian root, 8g forsythia, 6g chicken bone grass, 5g artemisia capillaris, 7g apocynum venetum, 8g rhubarb, 6g prepared rehmannia root, 5g schisandra fruit, 7g frankincense, 6g myrrh, 8g chuanxiong rhizome.

[0020] The preparation method is as follows: Select medicinal materials, remove impurities and non-medicinal parts, rinse with water and drain, place in a hot air circulating oven, dry at 55℃ for 2 hours until the moisture content is ≤8%, remove and immediately grind into powder using a pulverizer, pass through a 200-mesh sieve, and collect the sieve residue for later use; spread the powder in a sterilization tray with a thickness not exceeding 2cm, place in an ultraviolet irradiation chamber, and sterilize by irradiation at an intensity of 0.8W / m² for 40 minutes, turning it over every 10 minutes to ensure uniform sterilization; use an electronic analytical balance to weigh the powder according to the formula ratio, controlling the weighing error to ±0.1g. Within the specified range, and keep records; put the powder into the mixer, set the speed to 30 rpm, and mix for 45 minutes until the powder color is uniform; pass the powder through a 300-mesh vibrating sieve to remove fibers and impurities, and collect the powder; spread the powder on a tray to a thickness of about 1 cm, place it in a drying oven, and dehydrate and dry it at 60℃ for 1.5 hours until the moisture content is ≤5%; S7, Packaging and bagging: use a packaging machine to dispense the powder into non-woven bags, each bag containing 40g, use a heat sealing machine to seal the bag opening at 130℃, cover with aluminum foil, and store in a cool and dry place.

[0021] Example 2: Ingredient ratio: Safflower 7g, Ground beetle 6g, Leech 8g, Akebia stem 5.5g, Mistletoe 9g, Tabanus 7g, Sappanwood 6g, Salvia miltiorrhiza 9g, Red peony root 7g, Natural copper 6g, Catechu 8g, Dragon bone 9g, Oyster shell 7g, Gastrodia elata 8g, Dragon's blood 6g, Actinidia chinensis root bark 7g, Gentian root 6g, Forsythia suspensa 9g, Abrus precatorius 7g, Artemisia capillaris 6g, Apocynum venetum 8g, Rhubarb 9g, Rehmannia glutinosa 7g, Schisandra chinensis 6g, Frankincense 8g, Myrrh 7g, Ligusticum chuanxiong 9g.

[0022] The preparation method is as follows: Select medicinal materials, rinse with water and drain, spread on a drying tray, and dry in a hot air drying oven at 50℃ for 2.5 hours. When the moisture content of the medicinal materials is ≤8%, remove them and immediately pulverize them using a pulverizer, pass them through a 200-mesh sieve, and collect the fine powder. Put the powder into a container and sterilize it using a pressure steam sterilizer. Set the temperature to 115℃, the pressure to 0.12MPa, and the sterilization time to 30 minutes. After sterilization, cool to room temperature. In a clean workbench, use an electronic balance to weigh the powder according to the formula, controlling the error to within ±0.1g, and place it into separate containers. Put the powder into a mixer. Set the speed to 25 rpm and mix for 50 minutes until the powder color is uniform. Transfer the powder to a vibrating sieve and pass it through a 300-mesh sieve to remove particles and fibrous impurities. Spread the powder on a tray with a thickness of 1.5 cm and place it in a vacuum drying oven. Dehydrate it for 2 hours at 58℃ and -0.08 MPa until the moisture content is ≤5%. S7. Packaging: Using a packaging production line, dispense the powder into non-woven bags, each containing 35 g. Seal the bags at 125℃ using a heat sealer. Finally, seal the outer packaging with aluminum foil bags and store in a dry environment.

[0023] Example 3: Ingredient ratio: 8g safflower, 7g ground beetle, 9g leech, 6g akebia stem, 10g mulberry mistletoe, 8g horsefly, 7g sappanwood, 10g salvia miltiorrhiza, 9g red peony root, 7g natural copper, 9g catechu, 10g dragon bone, 8g oyster shell, 9g gastrodia elata, 7g dragon's blood, 8g vine root bark, 7g gentian root, 10g forsythia, 9g chicken bone grass, 8g artemisia capillaris, 9g apocynum venetum, 10g rhubarb, 8g prepared rehmannia root, 7g schisandra fruit, 9g frankincense, 8g myrrh, 10g chuanxiong rhizome.

[0024] The preparation method is as follows: Select medicinal materials, rinse with water and drain, place in a microwave vacuum dryer, dry at 60℃ and -0.06MPa for 1.5 hours until the moisture content is ≤8%, immediately pulverize with a pulverizer, pass through a 200-mesh sieve, and collect the powder; spread the powder in a tray and place it in an ultraviolet irradiation sterilization device, set the irradiation intensity to 1.0W / m², sterilize for 30 minutes, and rotate the tray to ensure uniform irradiation; in a clean room, use an electronic balance to weigh the powder according to the formula, controlling the weighing error within ±0.1g. The process is double-checked; the powder is added to a mixer, the speed is set to 35 rpm, and the mixture is mixed for 40 minutes. Sampling is used to ensure the uniformity of the mixture; the powder is sieved through a 300-mesh sieve using a sieving machine to remove impurities and fibers under negative pressure to obtain the powder; the powder is spread on a dryer and dehydrated at 65°C for 1 hour until the moisture content is ≤5%; the powder is packaged into non-woven bags, each containing 45g, and sealed by heat sealing at 140°C. The outer packaging is made of composite film and stored in a warehouse.

[0025] Effect verification To verify the clinical efficacy of the external application pack of this invention, a randomized controlled trial was conducted on 120 patients with cervical and lumbar spondylosis. The treatment group (n=80) used the external application pack of this invention, while the control group (n=40) used traditional external application powder. Results after 4 weeks of treatment showed: Improvement in pain intensity: The visual analog scale (VAS) score in the treatment group decreased from 6.8±1.2 points at baseline to 2.1±0.8 points, with an improvement rate of 69.1%, which was significantly higher than 48.5% in the control group (P<0.01). Joint function recovery: The JOA score in the treatment group increased from 12.5±2.8 to 23.6±3.1, with a functional improvement rate of 68.8%, which was significantly better than the 55.2% in the control group (P<0.05). Clinical symptom relief: The average time for relief of symptoms such as joint stiffness, swelling, and tenderness in the treatment group was 5.2 ± 1.3 days, which was 3.6 days shorter than that in the control group (P<0.01). Imaging improvements: X-rays in the treatment group showed an improvement rate of 42.5% in joint space and a reduction rate of 78.8% in soft tissue swelling, both significantly higher than those in the control group; Safety evaluation: Only 3 cases in the treatment group experienced mild skin irritation, with an incidence rate of 3.75%, which was not significantly different from the control group.

[0026] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A topical medicated pack for cervical and lumbar vertebral hyperplasia and swelling, characterized in that... Made from the following ingredients in parts by weight: safflower 6-8g, ground beetle 5-7g, leech 7-9g, akebia stem 5-6g, mulberry mistletoe 8-10g, horsefly 6-8g, sappanwood 5-7g, salvia miltiorrhiza 8-10g, red peony root 6-9g, natural copper 5-7g, catechu 7-9g, dragon bone 8-10g, oyster shell 6-8g, gastrodia elata 7-9g, dragon's blood 5-7g, actingaria root bark 6-8g, gentian root 5-7g, forsythia 8-10g, chicken bone grass 6-9g, artemisia capillaris 5-8g, apocynum venetum 7-9g, rhubarb 8-10g, prepared rehmannia root 6-8g, schisandra fruit 5-7g, frankincense 7-9g, myrrh 6-8g, chuanxiong rhizome 8-10g.

2. The external application pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 1, characterized in that: The akebia is either Aristolochia manshuriensis or Aristolochia debilis.

3. The external application pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 1, characterized in that: The horsefly is one of the dried bodies of the horsefly or the yellow horsefly.

4. The external application pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 1, characterized in that: The natural copper is calcined natural copper with a particle size ≤ 0.5 mm.

5. A method for preparing a topical medicated pack for cervical and lumbar vertebral hyperplasia and swelling, characterized in that: Includes the following steps: S1. Herbal Powdering: After washing the raw medicinal materials, dry them until the moisture content is ≤8%, then grind them into fine powder and pass them through a 200-mesh sieve; S2. Sterilization: Sterilize the powder by ultraviolet irradiation or high-temperature steam; S3. Precise Weighing: Weigh each herbal powder according to the formula ratio using an electronic balance, with the error controlled within ±0.1g; S4. Mixing and Homogenizing: Put the weighed powder into a three-dimensional motion mixer and mix until the color is uniform; S5. Powder Purification: Pass the mixed powder through a 300-mesh sieve again to remove fibers and impurities; S6. Drying and Dehydration: Spread the powder evenly on a tray and place it in an oven to dehydrate until the moisture content is ≤5%; S7. Packaging and Bagging: Divide the powder into 30-50g packages and pack them into non-woven bags, then heat-seal them.

6. The method for preparing the external application medicine pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 5, characterized in that: The drying temperature in S1 is 50-60℃, and the drying time is 2 hours.

7. The method for preparing the external application medicine pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 5, characterized in that: The ultraviolet irradiation intensity in S2 is 0.5-1.0 W / m², and the irradiation time is 30-60 minutes; The high-temperature steam sterilization temperature is 100-121℃, and the time is 20-40 minutes.

8. The method for preparing the external application medicine pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 5, characterized in that: The mixing speed in S4 is 20-40 rpm, and the mixing time is 30-60 minutes.

9. The method for preparing the external application medicine pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 5, characterized in that: The drying temperature in S6 is 55-65℃, and the drying time is 1-2 hours.

10. The method for preparing the external application medicine pack for cervical and lumbar vertebral hyperplasia and swelling according to claim 5, characterized in that: The non-woven bag in S7 is a breathable medical non-woven fabric with a sealing temperature of 120-140℃.