Traditional Chinese medicine pill for treating high uric acid and preparation process thereof

Abstract

The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine pill for treating high uric acid and a preparation process thereof. The invention provides a traditional Chinese medicine pill for treating high uric acid. The traditional Chinese medicine composition is characterized by comprising the following components in percentage by weight: 5% of curcuma zedoary, 4% of immature bitter orange, 2% of golden cypress, 3% of poria cocos, 4% of astragalus membranaceus, 3% of cinnamon, 2% of cowherb seed, 2% of gallnut, 2% of clove, 2% of rheum officinale, 2% of sappan wood, 4% of ligusticum wallichii, 3% of honeysuckle, 1.5% of scorpio, 2% of liquorice, 2% of fructus cnidii, 1.5% of asarum, 0.05% of diclofenac, 0.05% of piroxicam, 14.9% of honey and 40% of syrup. The preparation method has the beneficial effects that the preparation process is reasonable: in the preparation process, the weighing precision of each raw material is strictly controlled, so that the accuracy of the formula is ensured; appropriate crushing meshes and a low-temperature crushing process are adopted, so that the dissolution rate of the medicine is improved, and effective components are reserved; an equivalent progressive increase mixing method and a three-dimensional mixing machine are adopted in the mixing process, so that all the components are uniformly mixed; and controlling the hardness of the soft material and the specification of the pill in the pill making process.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine, and in particular to a traditional Chinese medicine pill for treating hyperuricemia and a preparation process thereof. Background Art

[0002] Hyperuricemia is a common metabolic disease. Long-term high uric acid levels can easily lead to serious complications such as gout and kidney stones, severely impacting patients' health and quality of life. Currently, the medications available on the market for treating hyperuricemia are primarily divided into Western and Traditional Chinese Medicine (TCM). While Western medicines are fast-acting, they also have numerous side effects, such as gastrointestinal discomfort and liver and kidney damage, placing a significant burden on patients with long-term use. While existing TCM preparations have relatively few side effects, their therapeutic effects sometimes fail to meet clinical needs, often exhibiting issues such as insignificant efficacy and slow onset of action.

[0003] Therefore, developing a safe, effective and low-side-effect drug for treating hyperuricemia is of great practical significance. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine pill for treating high uric acid and a preparation process thereof, wherein the traditional Chinese medicine pill can effectively reduce uric acid levels with minimal side effects; at the same time, a scientific and reasonable preparation process is provided to ensure the quality and efficacy of the traditional Chinese medicine pill.

[0005] The invention provides a traditional Chinese medicine pill for treating high uric acid. The traditional Chinese medicine pill is composed of the following ingredients in percentage by weight: 5% of zedoary zedoary, 4% of immature bitter orange, 2% of phellodendron, 3% of tuckahoe, 4% of astragalus, 3% of cinnamon bark, 2% of vaccaria segetalis, 2% of gallnut, 2% of clove, 2% of rhubarb, 2% of sappan wood, 4% of ligusticum chuanxiong, 3% of honeysuckle, 1.5% of scorpion, 2% of liquorice, 2% of cnidium monnieri, 1.5% of asarum, 0.05% of diclofenac, 0.05% of piroxicam, 14.9% of honey and 40% of syrup.

[0006] The preparation process of the Chinese medicine pill comprises the following steps:

[0007] Weighing raw materials: Accurately weigh each component according to weight percentage. The weighing accuracy of traditional Chinese medicine components is ±0.5g, and the weighing accuracy of chemical medicine components is ±0.01g;

[0008] Crushing: Crush zedoaria, immature bitter orange, phellodendron, poria, astragalus, cinnamon bark, vaccaria segetalis, gallnut, clove, rhubarb, sappan wood, ligusticum chuanxiong, honeysuckle, scorpion, liquorice, cnidium monnieri, and asarum separately, and pass through a 100-120 mesh sieve to adjust the particle size distribution of the Chinese medicine powder to 50-150 μm; for animal medicinal materials such as scorpion, adopt a low-temperature crushing process, and control the ambient temperature during crushing at -10°C to -5°C to prevent the active ingredients from being destroyed by heat;

[0009] Mixing: Place the crushed Chinese medicine powder, diclofenac and piroxicam in a three-dimensional mixer, and use an equal amount incremental mixing method to first mix the diclofenac and piroxicam with a small amount of Chinese medicine powder, then gradually add the remaining Chinese medicine powder, and mix at a speed of 30-40 r / min for 20-30 minutes, so that the content uniformity deviation of each component in the mixed powder does not exceed ±5%;

[0010] Pill making: Add honey and syrup melted at 60-80°C to the mixed powder, control the stirring speed at 50-80r / min, and stir for 10-15 minutes to make a plastic soft material. The hardness of the soft material should be such that it can be kneaded into a ball by hand and disintegrates when pressed lightly. The prepared pills have a diameter of 5-6mm and a single pill weight of 0.2-0.3g, with a pill weight variation of no more than ±5%.

[0011] Drying: Place the prepared pills in a hot air circulation drying oven, control the drying temperature at 55-60°C, and dry for 4-6 hours to reduce the moisture content of the pills to 4%-5%;

[0012] Packaging: Use aluminum-plastic blister packaging or glass bottle sealed packaging. The humidity of the packaging environment is controlled at 45%-60% RH and the temperature is controlled at 20-25℃.

[0013] Furthermore, the Chinese medicine pills are in the form of water-honeyed pills or honeyed pills, wherein the honey has a Baume degree of 40-42° and the syrup concentration is 60%-70% (w / w). During the preparation of the Chinese medicine pills, an appropriate amount of disintegrant may be added, wherein the disintegrant is sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose, with the amount added being 0.5%-1% by weight of the mixed powder. The Chinese medicine pills are approximately four grams, and one is taken daily, morning and evening. The percentage of the Chinese medicine pills is calculated based on the total amount of four Chinese medicine pills.

[0014] The beneficial effects of the present invention are:

[0015] The formula is scientific and effective: In the Chinese medicine pill formula of the present invention, Curcuma zedoaria breaks blood and promotes qi, eliminates accumulation and relieves pain; Citrus aurantium breaks qi and eliminates accumulation, resolves phlegm and relieves bloating; Phellodendron chinense clears heat and dries dampness, purges fire and detoxifies; Poria promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind; Astragalus replenishes qi and raises yang, consolidates the exterior and stops sweating; Cinnamon replenishes fire and supports yang, and guides fire back to its source; Vaccaria segetalis promotes blood circulation and promotes menstruation, promotes lactation and reduces swelling; Gallnut astringes the lungs and reduces fire, astringes the intestines and stops diarrhea; Clove warms the middle and reduces adverse reactions, nourishes the kidney and supports yang; Rhubarb is a laxative, attacks accumulation, clears heat and purges fire; Sappanwood promotes blood circulation and removes blood stasis, reduces swelling and relieves pain; Chuanxiong promotes blood circulation The herbal ingredients are compatible with each other and work together to clear away heat and dampness, activate blood circulation and remove blood stasis, dredge meridians and relieve pain, and regulate metabolism, effectively lowering uric acid levels. At the same time, adding a small amount of diclofenac and piroxicam can enhance the anti-inflammatory and analgesic effects, synergize with the herbal ingredients, and improve the therapeutic effect.

[0016] Reasonable preparation process: During the preparation process, the weighing accuracy of each raw material is strictly controlled to ensure the accuracy of the formula; the use of appropriate grinding mesh and low-temperature grinding process is conducive to improving the solubility of the drug and the retention of active ingredients; the equal amount incremental mixing method and three-dimensional mixer are used in the mixing process to ensure the uniform mixing of each component; the control of soft material hardness and pill specifications during the pill making process, as well as the parameter setting of the drying and packaging links, all guarantee the quality stability and efficacy reliability of the traditional Chinese medicine pills;

[0017] Small side effects: The present invention mainly uses traditional Chinese medicine ingredients, and the amount of chemical medicine ingredients is extremely small. Compared with simple Western medicine treatment, the side effects of the drugs are greatly reduced, and the long-term use of patients is highly safe.

[0018] Obviously, based on the above contents of the present invention, according to common technical knowledge and customary means in this field, without departing from the above basic technical ideas of the present invention, other various forms of modifications, replacements or changes can be made.

[0019] The following further describes the above content of the present invention in detail through specific embodiments in the form of examples. However, this should not be construed as limiting the scope of the above subject matter of the present invention to the following examples. All technologies implemented based on the above content of the present invention fall within the scope of the present invention. DETAILED DESCRIPTION

[0020] The present invention is described below with specific examples, which are not intended to limit the present invention.

[0021] Example 1,

[0022] Weigh the raw materials: weigh 50g of Curcuma zedoaria, 40g of Citrus aurantium, 20g of Phellodendron chinense, 30g of Poria cocos, 40g of Astragalus membranaceus, 30g of cinnamon bark, 20g of Vaccaria segetalis, 20g of Gallnut, 20g of Clove, 20g of Rhubarb, 20g of Sappan wood, 40g of Chuanxiong, 30g of Honeysuckle, 15g of Scorpion, 20g of Licorice, 20g of Cnidium monnieri, 15g of Asarum, 0.5g of Diclofenac, 0.5g of Piroxicam, 149g of honey, and 400g of syrup according to weight percentage.

[0023] Crushing: crush each Chinese medicine component separately. The whole scorpion adopts low-temperature crushing process and is crushed at -8℃. The other Chinese medicines are crushed normally and then all are sieved through a 110-mesh sieve.

[0024] Mixing: First, mix diclofenac and piroxicam with a small amount of traditional Chinese medicine powder, then gradually add the remaining traditional Chinese medicine powder, place in a three-dimensional mixer, and mix at a speed of 35r / min for 25 minutes.

[0025] Pill making: heat honey and syrup to 70℃ to melt, add them to the mixed powder, stir at a stirring rate of 65r / min for 12 minutes to make a plastic soft material, and make pills with a diameter of 5.5mm and a single pill weight of 0.25g.

[0026] Drying: Place the pills in a hot air circulation drying oven and dry them at 58°C for 5 hours to reduce the moisture content to 4.5%.

[0027] Packaging: Aluminum-plastic blister packaging is used. The packaging environment humidity is controlled at 50% RH and the temperature is controlled at 22℃.

[0028] Example 2,

[0029] Weigh the raw materials: weigh 50g of Curcuma zedoaria, 40g of Citrus aurantium, 20g of Phellodendron chinense, 30g of Poria cocos, 40g of Astragalus membranaceus, 30g of cinnamon bark, 20g of Vaccaria segetalis, 20g of Gallnut, 20g of Clove, 20g of Rhubarb, 20g of Sappan wood, 40g of Chuanxiong, 30g of Honeysuckle, 15g of Scorpion, 20g of Licorice, 20g of Cnidium monnieri, 15g of Asarum, 0.5g of Diclofenac, 0.5g of Piroxicam, 149g of honey, and 400g of syrup by weight, and add 5g of sodium carboxymethyl starch (0.5% by weight of the mixed powder) as a disintegrant.

[0030] Crushing: crush each Chinese medicine component separately. The whole scorpion is crushed by low-temperature crushing process at -10℃. The other Chinese medicines are crushed normally and then all are sieved through 100 mesh.

[0031] Mixing: First, mix diclofenac, piroxicam and sodium carboxymethyl starch with a small amount of traditional Chinese medicine powder, then gradually add the remaining traditional Chinese medicine powder, place in a three-dimensional mixer, and mix at a speed of 30r / min for 30 minutes.

[0032] Pill making: heat honey and syrup to 60℃ to melt, add them to the mixed powder, stir at a stirring rate of 50r / min for 15 minutes to make a plastic soft material, and make pills with a diameter of 5mm and a single pill weight of 0.2g.

[0033] Drying: Place the pills in a hot air circulation drying oven and dry them at 55°C for 6 hours to reduce the moisture content to 4%.

[0034] Packaging: sealed in glass bottles, the packaging environment humidity is controlled at 45% RH, and the temperature is controlled at 20℃.

[0035] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0036] The above description is only a preferred embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made by using the contents of the present invention specification under the inventive concept of the present invention, or direct / indirect application in other related technical fields are included in the patent protection scope of the present invention.

[0037] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine pill for treating high uric acid, characterized in that: The invention is composed of the following ingredients in percentage by weight: 5% of zedoary zedoary, 4% of immature bitter orange, 2% of phellodendron, 3% of tuckahoe, 4% of astragalus, 3% of cinnamon bark, 2% of vaccaria segetalis, 2% of gallnut, 2% of clove, 2% of rhubarb, 2% of sappan wood, 4% of ligusticum chuanxiong, 3% of honeysuckle, 1.5% of scorpion, 2% of liquorice, 2% of cnidium monnieri, 1.5% of asarum, 0.05% of diclofenac, 0.05% of piroxicam, 14.9% of honey and 40% of syrup.

2. The Chinese medicinal pill for treating high uric acid according to claim 1, characterized in that: The preparation process of the Chinese medicine pill comprises the following steps: Weighing raw materials: Accurately weigh each component according to weight percentage. The weighing accuracy of traditional Chinese medicine components is ±0.5g, and the weighing accuracy of chemical medicine components is ±0.01g; Grinding: Grind zedoaria, immature bitter orange, phellodendron, poria, astragalus, cinnamon bark, vaccaria, gallnut, clove, rhubarb, sappan wood, ligusticum chuanxiong, honeysuckle, scorpion, liquorice, cnidium monnieri, and asarum separately, and pass through a 100-120 mesh sieve to make the particle size distribution of the Chinese medicine powder between 50-150 μm; Mixing: Place the crushed Chinese medicine powder, diclofenac and piroxicam in a three-dimensional mixer and mix at a speed of 30-40 r / min for 20-30 minutes, so that the content uniformity deviation of each component in the mixed powder does not exceed ±5%; Pill making: add honey and syrup melted at 60-80℃ to the mixed powder, control the stirring speed at 50-80r / min, and stir for 10-15 minutes to make a plastic soft material. The hardness of the soft material should be such that it can be kneaded into a ball by hand and will fall apart when pressed lightly. Drying: Place the prepared pills in a hot air circulation drying oven, control the drying temperature at 55-60°C, and dry for 4-6 hours to reduce the moisture content of the pills to 4%-5%; Packaging: Use aluminum-plastic blister packaging or glass bottle sealed packaging. The humidity of the packaging environment is controlled at 45%-60% RH and the temperature is controlled at 20-25℃.

3. The preparation process of the Chinese medicine pill according to claim 2, characterized in that: In the pulverization step, for animal medicinal materials such as scorpions, a low-temperature pulverization process is adopted, and the ambient temperature during pulverization is controlled at -10°C to -5°C to prevent the effective ingredients from being destroyed by heat.

4. The preparation process of the Chinese medicine pill according to claim 2, characterized in that: In the mixing step, an equal amount incremental mixing method is adopted, wherein diclofenac and piroxicam are firstly mixed evenly with a small amount of traditional Chinese medicine powder, and then the remaining traditional Chinese medicine powder is gradually added and mixed.

5. The preparation process of the Chinese medicine pill according to claim 2, characterized in that: In the pill-making step, the diameter of the prepared pills is 5-6 mm, the weight of a single pill is 0.2-0.3 g, and the difference in pill weight does not exceed ±5%.

6. The Chinese medicinal pill for treating high uric acid according to claim 1, characterized in that: The dosage form of the traditional Chinese medicine pills is water-honey pills or honey pills, wherein the degree of Baume of the honey is 40-42°Bé, and the concentration of the syrup is 60%-70% (w / w).

7. The Chinese medicinal pill for treating high uric acid according to claim 1, characterized in that: During the preparation of the Chinese medicine pills, an appropriate amount of disintegrant can be added. The disintegrant is sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose, and the amount added is 0.5%-1% of the weight of the mixed powder.

8. The Chinese medicinal pill for treating high uric acid according to claim 1, characterized in that: The Chinese medicine pill is taken orally. The Chinese medicine pill is about four grams, and one is taken in the morning and evening every day.

9. The Chinese medicinal pill for treating high uric acid according to claim 1, characterized in that: The percentage of the Chinese medicine pills is calculated based on the total amount of four Chinese medicine pills.