Arthralgia-syndrome-relieving pain-relieving granules and preparation process thereof

Abstract

The invention discloses arthralgia-syndrome-relieving particles and a preparation process thereof, and belongs to the technical field of Yi medicine, the arthralgia-syndrome-relieving particles are prepared by scientific compatibility of multiple traditional Chinese medicinal materials including wine-processed radix paeoniae alba, fried pawpaw, wine-processed herba epimedii and the like, during preparation, the medicinal materials are firstly subjected to pretreatment such as cleaning and cutting, then are extracted through a decoction method, a percolation method and the like, and finally, the traditional Chinese medicinal materials are prepared into the arthralgia-syndrome-relieving particles. And concentrating, drying and granulating. The arthralgia-syndrome-relieving granules have the effects of warming meridians, activating blood, dredging collaterals, expelling wind-damp, relieving pain and diminishing swelling, all the medicinal materials are processed and selected to achieve specific effects for rheumatic arthralgia and other diseases caused by wind-cold-dampness arthralgia and qi-stagnation and blood stasis, for example, wine-processed radix paeoniae alba can enrich blood, regulate menstruation, calm the liver, relieve pain and the like, the formula is scientific and reasonable, the process is advanced, the curative effect can be remarkably improved, adverse reactions are reduced, and the curative effect is remarkable. The traditional Chinese medicine composition is convenient for patients to use, promotes the modernization process of ethnic medicines, provides convenient and effective treatment choices for the patients, is particularly suitable for patients with rheumatic arthralgia, ankle arthralgia, knee arthralgia and the like, and assists the patients to relieve pain and recover health.

Description

Technical Field

[0001] The invention belongs to the technical field of Yi medicine, and in particular relates to Bizhengling analgesic granules and a preparation process thereof. Background Art

[0002] As a traditional treasure of the Chinese nation, ethnic medicine has unique advantages in treating chronic diseases and regulating body functions. In recent years, with the acceleration of the modernization of traditional Chinese medicine, the technology of Chinese medicine formula granules has developed rapidly, which has improved the extraction efficiency and quality of Chinese medicine, made it more convenient for patients to use, and improved the treatment effect.

[0003] In the research and development and application of drugs such as Bi Zheng Ling Pain Relief Granules, ethnic medicine formula granule technology plays an important role. As a commonly used Yi medicine, Bi Zheng Ling Pain Relief Granules have the effects of warming the meridians and activating blood circulation, unblocking meridians and eliminating rheumatism, relieving pain and reducing swelling. It is widely used in the treatment of rheumatic arthritis, knee arthritis and other diseases.

[0004] The prior art has the following defects:

[0005] Unclear explanation of the pharmacodynamic mechanism: The pharmacodynamic mechanism of Bizhengling Pain-relieving Granules is still unclear, and the interaction between the various components and the specific mechanism of action on the human body need to be further studied;

[0006] Insufficient formulation optimization: The formulation ingredients of Bizhengling Pain Relief Granules are complex and diverse. The ratio and combination of different ingredients may have a significant impact on its efficacy, but the optimization work in this regard is still insufficient;

[0007] Weak response to individual differences: Due to the large individual differences in physique, age, condition, etc., the efficacy of Bizhengling Pain Relief Granules on different patients varies greatly. How to provide personalized treatment based on the specific conditions of the patients is a major challenge facing the current existing technologies;

[0008] Poor resolution of adverse reactions: During the use of Bizhengling Analgesic Granules, adverse reactions such as allergies and gastrointestinal discomfort may occur. The occurrence of these adverse reactions is closely related to many factors such as the patient's constitution, dosage, and method of medication. Currently, the monitoring and prevention measures for these adverse reactions still need to be further improved. Summary of the invention

[0009] The purpose of the present invention is to solve the above-mentioned problems and to propose Bi Zheng Ling analgesic granules and their preparation process.

[0010] To achieve the above-mentioned purpose, the present invention adopts the following technical scheme: Bi Zheng Ling analgesic granules are composed of the following Chinese medicinal materials in parts by weight: 30g-60g of white peony root, 15g-25g of papaya, 10g-20g of epimedium, 15g-25g of Achyranthes bidentata, 20g-30g of Clematidis, 20g-30g of Angelica dahurica, 15g-25g of Chuanxiong, 20g-30g of Drynaria, 12g-24g of Angelica sinensis, 15g-25g of Rehmannia root, 15g-25g of Saposhnikovia divaricata, 20g-30g of Psoralea corylifolia, 10g-20g of raw licorice (Ayi - Yi language name), and 20g-30g of Herba schizonepetae. These Chinese medicinal materials are processed specifically to achieve specific therapeutic effects.

[0011] In the above-mentioned Bizhengling analgesic granules, the Chinese medicinal materials are processed by the following processing methods:

[0012] White peony root with wine: mix white peony root with appropriate amount of yellow wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low fire, fry it until it turns slightly yellow, take it out and let it cool;

[0013] Stir-fry papaya. Place papaya in a stir-fry container, heat over low heat until light yellow, then take out and let cool.

[0014] Wine Epimedium: Mix Epimedium with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low heat, fry until it turns slightly yellow, take it out and let it cool;

[0015] Salted Achyranthes, mix Achyranthes with appropriate amount of salt water, and let it soak for a while. After the salt water is completely absorbed, put it in a frying container, heat it over a low heat, fry it until it is slightly dry, take it out and let it cool;

[0016] Wine Clematis: Mix the Clematis with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low heat, fry until it turns slightly yellow, take it out and let it cool;

[0017] Wine-cooked Angelica dahurica: Mix Angelica dahurica with rice wine, let it soak for a while, and when the wine is completely absorbed, put it in a frying container, heat it over a low fire, fry until it turns slightly yellow, take it out and let it cool;

[0018] Ligusticum chuanxiong with wine: Mix ligusticum chuanxiong with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low fire, fry it until it turns slightly yellow, take it out and let it cool;

[0019] Raw bone drynaria, use raw bone drynaria directly;

[0020] Wine angelica: Mix angelica with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low fire, fry until it turns slightly yellow, take it out and let it cool;

[0021] Rehmannia root, use Rehmannia root directly;

[0022] Raw Saposhnikovia, use raw Saposhnikovia directly;

[0023] Salted Psoralea corylifolia: Mix Psoralea corylifolia with appropriate amount of salt water, and let it soak for a while. After the salt water is completely absorbed, put it in a frying container, heat it over a low heat, fry it until it is slightly dry, and take it out to cool.

[0024] Raw licorice, use raw licorice directly;

[0025] Raw radix polygoni multiflori, use raw radix polygoni multiflori directly.

[0026] The above-mentioned Bi Zheng Ling Analgesic Granules are used for "rheumatic arthralgia, ankle arthralgia, and knee arthralgia" caused by wind-cold-dampness obstruction and qi stagnation and blood stasis. The specific symptoms include ankle and knee joint pain, swelling, limited movement, fear of cold, obvious tenderness, and aggravation after activities when exposed to wind and cold or weather changes. In terms of Western medicine diseases, it is mainly used for "ankle and knee joint bone hyperplasia and arthritis, lumbar vertebrae bone hyperplasia."

[0027] In the above-mentioned Bi Zheng Ling Analgesic Granules, the dosage is 1 bag / time, 20g / time, taken with boiled water, three times a day, divided into morning, noon and evening, taken after meals, and used strictly according to the prescribed usage and dosage to ensure the efficacy and safety of the drug.

[0028] In the above-mentioned Bi Zheng Ling Analgesic Granules, the packaging specification is 20 grams / bag, 10 bags per box. The standardized packaging is convenient for patients to use and store, and is also conducive to the production and management of drugs.

[0029] The present invention also discloses a preparation process of Bizhengling analgesic granules, which comprises the following steps:

[0030] S1. Pretreatment of medicinal materials:

[0031] a. Cleaning: Clean all the herbs as described in claim 1 to remove dirt, impurities, etc. on the surface;

[0032] b. Cutting: Slice or cut some medicinal materials into sections as needed to facilitate subsequent extraction;

[0033] S2. Extraction:

[0034] a. Soaking: Put the pre-treated medicinal materials into the extraction tank, add appropriate amount of water or ethanol and other solvents for soaking. The soaking time depends on the nature of the medicinal materials, usually several hours to overnight;

[0035] b. Extraction: Extraction is performed by decoction or percolation. The number of extractions and the extraction time are determined according to the active ingredient content of the medicinal materials and the extraction efficiency. The decoction method is usually to boil the medicinal materials and water together, and then keep the slightly boiling state for a certain period of time, and the extract is obtained after filtration; the percolation method is to continuously add solvents above the medicinal materials, so that it slowly penetrates through the medicinal material layer, and collect the exuded extract;

[0036] S3, concentration: the extracted medicinal solution is concentrated to remove excess water or solvent to obtain a concentrated solution; the concentration can be carried out by vacuum concentration, thin film evaporation and other methods;

[0037] S4, drying: drying the concentrated liquid to obtain dry paste powder. The drying method can be spray drying, vacuum drying or freeze drying, etc. The specific selection depends on the properties of the medicinal materials and production requirements;

[0038] S5. Granulation:

[0039] a. Mixing: Mix the dry paste powder with appropriate amount of auxiliary materials to improve the formability and solubility of the particles;

[0040] b. Making soft material: Add appropriate amount of wetting agent to make the mixed powder into soft material. The hardness of the soft material should be moderate to facilitate subsequent granulation;

[0041] c. Granulation: The soft material is made into granules through a screen or granulator. The size and uniformity of the granules should be well controlled during the granulation process;

[0042] d. Drying and granulation: The prepared wet granules are dried, and then sieved and granulated to obtain granules that meet the requirements.

[0043] In the above-mentioned preparation process of Bizhengling analgesic granules, the process parameters and quality standards of each link should be strictly controlled throughout the production process to ensure the quality and efficacy of the granules, including the following aspects:

[0044] Control the degree of cleaning and cutting specifications during the pretreatment of medicinal materials to ensure the purity of the medicinal materials and the appropriate extraction size;

[0045] Precisely control the soaking time, extraction method, extraction times and extraction time during the extraction process to fully extract the active ingredients in the medicinal materials while avoiding over-extraction or under-extraction;

[0046] Reasonable selection of concentration methods and parameters to ensure the concentration and quality of the concentrate while reducing the loss of active ingredients;

[0047] Select appropriate drying methods and parameters according to the properties of medicinal materials and product requirements to ensure the quality and stability of dry paste powder;

[0048] During the granulation process, the selection and dosage of auxiliary materials, the type and dosage of wetting agents, the hardness of soft materials, the granulation method and parameters, the drying temperature and time, and the specifications of the whole granules are strictly controlled to ensure the formability, solubility, size uniformity and quality stability of the granules;

[0049] Taking into account the diversity and complexity of medicinal materials, the specific production process may need to be adjusted and optimized according to actual conditions. In addition, since the preparation of Chinese medicine granules involves multiple links and complex technical requirements, it is recommended to carry out production under the guidance of professionals to ensure the safety, effectiveness and controllability of the production process.

[0050] Compared with the prior art, the advantages of the present invention are:

[0051] 1. Scientific and reasonable formula

[0052] After strict screening and scientific combination of a variety of Chinese medicinal materials, including blood-invigorating and blood-activating types (white peony root, Chuanxiong, Chinese angelica, Rehmannia root, licorice), rheumatism-relieving types (Angelica pubescens, Clematis chinensis, Achyranthes bidentata), meridian-warming and collateral-unblocking types (Drynhazakana, Epimedium, Papaya), etc., the ingredients work synergistically, and the overall therapeutic effect is better than that of a single ingredient, and it can more effectively treat diseases such as rheumatic arthralgia and knee arthritis.

[0053] 2. Advanced Preparation Technology

[0054] Using advanced Chinese medicine granule preparation technology, the Chinese medicinal materials are washed, dried, and crushed, and then made into granules through extraction, concentration, drying and other process steps. During the preparation process, parameters such as temperature and time are strictly controlled to ensure that the effective ingredients are fully extracted and retained, thereby improving the efficacy and stability of the product;

[0055] The use of aseptic packaging technology ensures the sanitary quality of the product, extends the shelf life of the product, and is also convenient for patients to carry and use.

[0056] 3. Personalized treatment

[0057] Developing a personalized treatment plan based on the patient's specific conditions (such as condition, physical constitution, etc.), and adjusting the medication dosage and course of treatment after a comprehensive assessment of the patient's condition can better meet the needs of different patients and improve treatment outcomes.

[0058] 4. Safe and reliable medication

[0059] In-depth research has been conducted on the safety of Bi Zheng Ling Analgesic Granules, including the monitoring of adverse reactions and the formulation of preventive measures. Due to the synergistic effect of the ingredients in the formula and the strict control of the preparation process, while the therapeutic effect is significant, the occurrence of adverse reactions can be reduced, making patients safer and more comfortable during the medication process.

[0060] V. Promote the modernization of ethnic medicine

[0061] The implementation of the present invention not only provides patients with more effective treatment options, but also promotes the modernization of ethnic medicine (Yi medicine). Through the application of scientific compatibility and advanced preparation technology, it provides strong support for the standardization and international development of traditional Chinese medicine (ethnic medicine). DETAILED DESCRIPTION

[0062] The following examples are for illustrative purposes only and are not intended to limit the scope of the present invention.

[0063] Embodiment 1

[0064] The Bi Zheng Ling Pain Relief Granules of this embodiment are targeted at "rheumatic arthralgia, ankle arthralgia, and knee arthralgia" caused by wind-cold-dampness arthralgia and qi stagnation and blood stasis, and are particularly suitable for patients with milder conditions and relatively peaceful constitutions.

[0065] Recipe composition:

[0066] Wine white peony root (Aqubaigen - called in Yi language) 30g, stir-fried papaya 15g, wine epimedium 10g, salt Achyranthes bidentata (Aniuxing - called in Yi language) 15g, wine Clematidis 20g, wine Angelica dahurica 20g, wine Chuanxiong (Achuanxiong - called in Yi language) 15g, raw Drynaria fortunei 20g, wine Angelica sinensis 12g, prepared Rehmannia root (Shui Adi - called in Yi language) 15g, raw Saposhnikovia divaricata 15g, salt Psoralea corylifolia 20g, raw Licorice root (Ayi - called in Yi language) 10g, raw Radix Penicillae 20g.

[0067] Preparation process:

[0068] Pretreatment of medicinal materials:

[0069] Cleaning: Clean all the above medicinal materials to remove dirt, impurities, etc. on the surface;

[0070] Cutting: Slice or cut some medicinal materials (such as large rhizomes) as needed to facilitate subsequent extraction;

[0071] extract:

[0072] Soaking: Put the pre-treated medicinal materials into the extraction tank, add appropriate amount of water and soak for 6 hours;

[0073] The extraction was carried out by decoction method, and the extraction was carried out twice, each extraction time was 1.5 hours, the medicinal materials and water were heated and boiled together, and then kept in a slightly boiling state, and the extract was filtered to obtain,

[0074] Concentration: The extracted medicinal solution is concentrated under reduced pressure to remove excess water to obtain a concentrated solution;

[0075] Drying: spray drying the concentrated liquid to obtain dry paste powder;

[0076] Granulation:

[0077] Mixing: Mix the dry paste powder and appropriate amount of dextrin evenly;

[0078] Making soft material: Add appropriate amount of ethanol to make the mixed powder into soft material;

[0079] Granulation: passing the soft material through a screen to form granules;

[0080] Drying and granulation: The prepared wet granules are dried, and then sieved and granulated to obtain granules that meet the requirements.

[0081] Medication guidance and clinical cases:

[0082] Dosage and Administration: 1 bag / time, 20g / time, take with boiled water, three times a day, divided into morning, noon and evening, take after meals.

[0083] Indications: It is used for "rheumatic arthralgia, ankle arthralgia, and knee arthralgia" caused by wind-cold-dampness obstruction as well as qi stagnation and blood stasis. Symptoms include ankle and knee joint pain, swelling, limited mobility, fear of cold, obvious tenderness, and aggravation after activities when exposed to wind-cold, weather changes, etc.

[0084] Contraindications: It is forbidden to use for diseases caused by dampness and heat, and pregnant women.

[0085] Precautions: Avoid smoking, drinking, spicy, cold, and greasy food; do not take bitter and cold Chinese patent medicines at the same time during the medication period; not suitable for people with wind-heat cold; patients with diabetes and those with severe chronic diseases such as hypertension, heart disease, liver disease, and kidney disease should take the medicine under the guidance of a physician; children, breastfeeding women, menstruating women, the elderly and the weak, and those with yin deficiency and internal heat should use it with caution. If the symptoms do not improve after taking the medicine for three days, you should go to the hospital for treatment; those who are allergic to this product are prohibited from using it, and those with allergic constitutions should use it with caution; it is prohibited to use this product when its properties change; children must use it under adult supervision; please keep this product out of reach of children; if you are using other medicines, please consult a physician or pharmacist before using this product.

[0086] Clinical case: Jiang, male, 52 years old, came to the hospital on November 2, 1996 with intermittent migratory pain in both ankle joints for 3 years, which worsened for 1 week. The Chinese medicine diagnosis was arthralgia (ankle arthralgia), with both arthralgia and pain arthralgia. He was treated with the Arthralgia Ling Pain-relieving Granules of the present embodiment, 7 doses, one dose every two days, three times a day, once in the morning, noon and evening, after meals. At the second visit, the joint pain was greatly reduced, and the symptoms of chills and coldness and cold limbs were also alleviated compared with the previous ones. The effect was not changed, and 14 doses of the above were continued. After two months of follow-up, the disease was cured.

[0087] Embodiment 2

[0088] The Bi Zheng Ling Pain Relief Granules of this embodiment are intended for patients with more serious conditions and obvious symptoms of bone hyperplasia.

[0089] Recipe composition:

[0090] Wine white peony root (Aqubaigen - Yi language name) 50g, stir-fried papaya 20g, wine epimedium 15g, salt Achyranthes bidentata (Aniuxing - Yi language name) 20g, wine clematis 30g, wine Duhuo 30g, wine Chuanxiong (Achuanxiong - Yi language name) 20g, raw bone drynaria 30g, wine angelica 15g, cooked rehmannia root (cooked Adi - Yi language name) 20g, raw Fangfeng 20g, salt psoralea corylifolia 30g, raw licorice (Ayi - Yi language name) 12g, raw radix pedunculata 30g,

[0091] Preparation process:

[0092] Pretreatment of medicinal materials:

[0093] Cleaning: Clean all the above medicinal materials to remove dirt, impurities, etc. on the surface.

[0094] Cutting: Slice or cut some medicinal materials (such as large rhizomes) as needed to facilitate subsequent extraction;

[0095] extract:

[0096] Soaking: put the pretreated medicinal materials into the extraction tank, add appropriate amount of ethanol and soak for 8 hours;

[0097] The percolation method is used for extraction, where ethanol is continuously added above the medicinal materials to allow it to slowly penetrate the medicinal material layer and the exuded extract is collected;

[0098] Concentration: The extracted drug solution is concentrated by thin film evaporation to remove excess solvent to obtain a concentrated solution;

[0099] Drying: vacuum drying the concentrated liquid to obtain dry paste powder;

[0100] Granulation:

[0101] Mixing: Mix the dry paste powder with appropriate amount of lactose;

[0102] Making soft material: Add appropriate amount of water to make the mixed powder into soft material;

[0103] Granulation: The soft material is made into granules by a granulator;

[0104] Drying and granulation: The prepared wet granules are dried, and then sieved and granulated to obtain granules that meet the requirements.

[0105] Medication guidance and clinical cases:

[0106] Dosage and Administration: 1 bag / time, 20g / time, take with boiled water, three times a day, divided into morning, noon and evening, take after meals.

[0107] Indications: It is used for "rheumatic pain, ankle pain, and knee pain" caused by wind-cold-dampness obstruction and qi stagnation and blood stasis, especially for patients with obvious symptoms of bone hyperplasia.

[0108] Contraindications: It is forbidden to use for diseases caused by dampness and heat, and pregnant women.

[0109] Precautions: Avoid smoking, drinking, spicy, cold, and greasy food; do not take bitter and cold Chinese patent medicines at the same time during the medication period; not suitable for people with wind-heat cold; patients with diabetes and those with severe chronic diseases such as hypertension, heart disease, liver disease, and kidney disease should take the medicine under the guidance of a physician; children, breastfeeding women, menstruating women, the elderly and the weak, and those with yin deficiency and internal heat should use it with caution. If the symptoms do not improve after taking the medicine for three days, you should go to the hospital for treatment; those who are allergic to this product are prohibited from using it, and those with allergic constitutions should use it with caution; it is prohibited to use this product when its properties change; children must use it under adult supervision; please keep this product out of reach of children; if you are using other medicines, please consult a physician or pharmacist before using this product.

[0110] Clinical case: Liu, female, 54 years old, went to the hospital on February 16, 2002. She had recurrent right knee arthritis for more than 10 years. The Chinese medicine diagnosis was arthralgia (knee arthralgia), painful arthralgia. She was treated with the Arthralgia Ling Pain-relieving Granules of the present embodiment, 7 doses, one dose every two days, three times a day, once in the morning, noon and evening, after meals. At the second visit, the joint pain was significantly relieved, the right knee joint activity function had been relieved, the right knee joint could be flexed and extended, and the joint was not swollen. Epimedium and Angelica were removed, and the above 14 doses were continued. The disease was cured after follow-up one month later.

[0111] Embodiment 3

[0112] The Bi Zheng Ling Pain Relief Granules of this embodiment are for patients with bone hyperplasia and slow recovery after fracture.

[0113] Recipe composition:

[0114] Wine white peony root (Aqubaigen - called in Yi language) 40g, stir-fried papaya 18g, wine epimedium 12g, salt Achyranthes bidentata (Aniuxing - called in Yi language) 18g, wine Clematidis 25g, wine Angelica dahurica 25g, wine Chuanxiong (Achuanxiong - called in Yi language) 18g, raw Drynaria fortunei 25g, wine Angelica sinensis 13g, prepared Rehmannia root (Shui Adi - called in Yi language) 18g, raw Saposhnikovia divaricata 18g, salt Psoralea corylifolia 25g, raw Licorice root (Ayi - called in Yi language) 11g, raw Herba scutellariae 25g.

[0115] Preparation process:

[0116] Pretreatment of medicinal materials:

[0117] Cleaning: Clean all the above medicinal materials to remove dirt, impurities, etc. on the surface;

[0118] Cutting: Slice or cut some medicinal materials (such as large rhizomes) as needed to facilitate subsequent extraction;

[0119] extract:

[0120] Soaking: Put the pretreated medicinal materials into an extraction tank, add an appropriate amount of a mixed solvent of water and ethanol and soak for 7 hours;

[0121] The extraction was carried out by combining decoction and percolation, firstly the decoction was carried out once for 2 hours, and then the percolation was carried out;

[0122] Concentration: The extracted drug solution is concentrated by combining reduced pressure concentration and thin film evaporation to remove excess water and solvent to obtain a concentrated solution;

[0123] Drying: freeze-drying the concentrated solution to obtain dry paste powder;

[0124] Granulation:

[0125] Mixing: Mix the dry paste powder with an appropriate amount of dextrin and lactose mixture.

[0126] Making soft material: adding a proper amount of ethanol and water mixed wetting agent to make the mixed powder into soft material;

[0127] Granulation: The soft material is passed through a screen and a granulator to form granules;

[0128] Drying and granulation: The prepared wet granules are dried, and then sieved and granulated to obtain granules that meet the requirements.

[0129] Medication guidance and clinical cases:

[0130] Dosage and Administration: 1 bag / time, 20g / time, take with boiled water, three times a day, divided into morning, noon and evening, take after meals.

[0131] Indications: It is used for "rheumatic pain, ankle pain, and knee pain" caused by wind-cold-dampness obstruction and qi stagnation and blood stasis, especially for patients with bone hyperplasia and slow recovery after fracture.

[0132] Contraindications: It is forbidden to use for diseases caused by dampness and heat, and pregnant women.

[0133] Precautions: Avoid smoking, drinking, spicy, cold, and greasy food; do not take bitter and cold Chinese patent medicines at the same time during the medication period; not suitable for people with wind-heat cold; patients with diabetes and those with severe chronic diseases such as hypertension, heart disease, liver disease, and kidney disease should take the medicine under the guidance of a physician; children, breastfeeding women, menstruating women, the elderly and the weak, and those with yin deficiency and internal heat should use it with caution. If the symptoms do not improve after taking the medicine for three days, you should go to the hospital for treatment; those who are allergic to this product are prohibited from using it, and those with allergic constitutions should use it with caution; it is prohibited to use this product when its properties change; children must use it under adult supervision; please keep this product out of reach of children; if you are using other medicines, please consult a physician or pharmacist before using this product.

[0134] Clinical case: Zhou, male, 64 years old, first visit: March 15, 2015, main complaint: pain and swelling after left ankle sprain for more than 2 months, recently aggravated with limited activity, treated with the Bi Zheng Ling analgesic granules of this embodiment, 1 bag / time, 20g per bag, taken with boiled water, three times a day, morning, noon and evening, after meals, taken for 14 days, after follow-up treatment, the patient's pain was relieved, swelling subsided, and joint mobility improved, continued the original treatment, took it for 1 month, followed up after 1 month, and was almost cured.

[0135] Embodiment 4

[0136] The Bi Zheng Ling Pain Relief Granules of this embodiment are intended for patients with pain in multiple joints.

[0137] Recipe composition:

[0138] Wine white peony root (Aqubaigen - called in Yi language) 45g, stir-fried papaya 22g, wine epimedium 14g, salt Achyranthes bidentata (Aniuxing - called in Yi language) 22g, wine Clematidis 28g, wine Angelica dahurica 28g, wine Chuanxiong (Achuanxiong - called in Yi language) 22g, raw Drynaria fortunei 28g, wine Angelica sinensis 14g, prepared Rehmannia root (prepared Adi - called in Yi language) 22g, raw Saposhnikovia divaricata 22g, salt Psoralea corylifolia 28g, raw Licorice root (Ayi - called in Yi language) 13g, raw Radix Penicillae 28g.

[0139] Preparation process:

[0140] Pretreatment of medicinal materials:

[0141] Cleaning: Clean all the above medicinal materials to remove dirt, impurities, etc. on the surface;

[0142] Cutting: Slice or cut some medicinal materials (such as large rhizomes) as needed to facilitate subsequent extraction;

[0143] extract:

[0144] Soaking: Put the pretreated medicinal materials into the extraction tank, add appropriate amount of water and soak for 7.5 hours;

[0145] The decoction method was used for multiple extractions, with each extraction lasting 1.8 hours;

[0146] Concentration: The extracted medicinal solution is concentrated under reduced pressure to remove excess water to obtain a concentrated solution;

[0147] Drying: spray drying the concentrated liquid to obtain dry paste powder;

[0148] Granulation:

[0149] Mixing: Mix the dry paste powder and appropriate amount of dextrin evenly;

[0150] Making soft material: Add appropriate amount of ethanol to make the mixed powder into soft material;

[0151] Granulation: passing the soft material through a screen to form granules;

[0152] Drying and granulation: The prepared wet granules are dried, and then sieved and granulated to obtain granules that meet the requirements.

[0153] Medication guidance and clinical cases:

[0154] Dosage and Administration: 1 bag / time, 20g / time, take with boiled water, three times a day, divided into morning, noon and evening, take after meals.

[0155] Indications: It is used for "rheumatic pain, ankle pain, and knee pain" caused by wind-cold-dampness obstruction and qi stagnation and blood stasis, especially for patients with pain in multiple joints.

[0156] Contraindications: It is forbidden to use for diseases caused by dampness and heat, and pregnant women.

[0157] Precautions: Avoid smoking, drinking, spicy, cold, and greasy food; do not take bitter and cold Chinese patent medicines at the same time during the medication period; not suitable for people with wind-heat cold; patients with diabetes and those with severe chronic diseases such as hypertension, heart disease, liver disease, and kidney disease should take the medicine under the guidance of a physician; children, breastfeeding women, menstruating women, the elderly and the weak, and those with yin deficiency and internal heat should use it with caution. If the symptoms do not improve after taking the medicine for three days, you should go to the hospital for treatment; those who are allergic to this product are prohibited from using it, and those with allergic constitutions should use it with caution; it is prohibited to use this product when its properties change; children must use it under adult supervision; please keep this product out of reach of children; if you are using other medicines, please consult a physician or pharmacist before using this product.

[0158] Clinical case: Tian, ​​female, 65 years old, visited the hospital on July 12, 2023, with current symptoms: severe pain in the knee joint of the lower limb for 3 days, accompanied by cold limbs, shoulder joint pain, and finger joint pain. The traditional Chinese medicine diagnosis was arthralgia (knee arthralgia and ankle arthralgia, leaking shoulder wind), and the Bi Zheng Ling analgesic granules of this embodiment were used for treatment, 1 bag / time, 20g per bag, taken with boiled water, three times a day, divided into morning, noon and evening, after meals, taken for 1 month, after follow-up treatment, the patient's knee joint pain was significantly relieved, and the shoulder joint was slightly relieved. The original treatment was continued for 1 month. Follow-up after 1 month showed basic relief, and it is recommended to continue taking it for another half a month.

[0159] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. Bizhengling analgesic granules, characterized in that: The medicine is composed of the following Chinese medicinal materials in parts by weight: 30g-60g of white peony root, 15g-25g of papaya, 10g-20g of epimedium, 15g-25g of Achyranthes bidentata, 20g-30g of Clematidis, 20g-30g of Angelica dahurica, 15g-25g of Chuanxiong, 20g-30g of Drynaria, 12g-24g of Angelica sinensis, 15g-25g of Rehmannia root, 15g-25g of Saposhnikovia divaricata, 20g-30g of Psoralea corylifolia, 10g-20g of raw licorice (called Ayi in Yi language), and 20g-30g of Herba spatholobi. These Chinese medicinal materials are processed specifically to achieve specific therapeutic effects.

2. The Bizhengling analgesic granules according to claim 1, characterized in that The Chinese medicinal materials are processed by the following processing methods: White peony root with wine: mix white peony root with appropriate amount of yellow wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low fire, fry until it turns slightly yellow, take it out and let it cool; Stir-fry papaya. Place papaya in a stir-fry container and heat over low heat until it turns slightly yellow. Remove and let cool. Wine Epimedium: Mix Epimedium with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low heat, fry until it turns slightly yellow, take it out and let it cool; Salted Achyranthes, mix Achyranthes with appropriate amount of salt water, and let it soak for a while. After the salt water is completely absorbed, put it in a frying container, heat it over a low heat, fry it until it is slightly dry, take it out and let it cool; Wine Clematis: Mix the Clematis with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low heat, fry until it turns slightly yellow, take it out and let it cool; Wine-cooked Angelica dahurica: Mix Angelica dahurica with rice wine, let it soak for a while, and when the wine is completely absorbed, put it in a frying container, heat it over a low heat, fry until it turns slightly yellow, take it out and let it cool; Ligusticum chuanxiong with wine: Mix ligusticum chuanxiong with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low fire, fry it until it turns slightly yellow, take it out and let it cool; Raw bone drynaria, use raw bone drynaria directly; Wine angelica: Mix angelica with rice wine, let it soak for a while, and when the wine is absorbed, put it in a frying container, heat it over a low heat, fry until it turns slightly yellow, take it out and let it cool; Rehmannia root, use Rehmannia root directly; Raw Saposhnikovia, use raw Saposhnikovia directly; Salted Psoralea corylifolia: Mix Psoralea corylifolia with appropriate amount of salt water, and let it soak for a while. After the salt water is completely absorbed, put it in a frying container, heat it over a low heat, fry it until it is slightly dry, and take it out to cool. Raw licorice, use raw licorice directly; Raw radix polygoni multiflori, use raw radix polygoni multiflori directly.

3. The Bizhengling analgesic granules according to claim 1, characterized in that: It is used for "rheumatic arthralgia, ankle arthralgia, and knee arthralgia" caused by wind-cold-dampness obstruction and qi stagnation and blood stasis. Specific symptoms include ankle and knee joint pain, swelling, limited movement, fear of cold, obvious tenderness, and aggravation after activities when exposed to wind and cold or weather changes. In terms of Western medicine diseases, it is mainly used for "ankle and knee joint bone hyperplasia and arthritis, and lumbar vertebrae bone hyperplasia." 4. The Bizhengling analgesic granules according to claim 1, characterized in that: The dosage is 1 bag / time, 20g / time, taken with boiled water, three times a day, divided into morning, noon and evening, and taken after meals. Use strictly according to the prescribed dosage to ensure the efficacy and safety of the drug.

5. The Bizhengling analgesic granules according to claim 1, characterized in that: The standard packaging is 20 grams per bag, with 10 bags per box. The standardized packaging is convenient for patients to use and store, and is also beneficial to the production and management of drugs.

6. The preparation process of Bizhengling analgesic granules according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Pretreatment of medicinal materials: a. Cleaning: Clean all the herbs as described in claim 1 to remove dirt, impurities, etc. on the surface; b. Cutting: Slice or cut some medicinal materials into sections as needed to facilitate subsequent extraction; S2. Extraction: a. Soaking: Put the pre-treated medicinal materials into the extraction tank, add appropriate amount of water or ethanol and other solvents for soaking. The soaking time depends on the nature of the medicinal materials, usually several hours to overnight; b. Extraction: Extraction is performed by decoction or percolation. The number of extractions and the extraction time are determined according to the active ingredient content of the medicinal materials and the extraction efficiency. The decoction method is usually to boil the medicinal materials and water together, and then keep the slightly boiling state for a certain period of time, and the extract is obtained after filtration; the percolation method is to continuously add solvents above the medicinal materials, so that it slowly penetrates through the medicinal material layer, and collect the exuded extract; S3, concentration: the extracted medicinal solution is concentrated to remove excess water or solvent to obtain a concentrated solution; the concentration can be carried out by vacuum concentration, thin film evaporation and other methods; S4, drying: drying the concentrated liquid to obtain dry paste powder. The drying method can be spray drying, vacuum drying or freeze drying, etc. The specific selection depends on the properties of the medicinal materials and production requirements; S5. Granulation: a. Mixing: Mix the dry paste powder with appropriate amount of auxiliary materials to improve the formability and solubility of the particles; b. Making soft material: Add appropriate amount of wetting agent to make the mixed powder into soft material. The hardness of the soft material should be moderate to facilitate subsequent granulation; c. Granulation: The soft material is made into granules through a screen or granulator. The size and uniformity of the granules should be well controlled during the granulation process; d. Drying and granulation: The prepared wet granules are dried, and then sieved and granulated to obtain granules that meet the requirements.

7. The preparation process of Bizhengling analgesic granules according to claim 6, characterized in that: Throughout the entire production process, the process parameters and quality standards of each link should be strictly controlled to ensure the quality and efficacy of the granules, including the following aspects: Control the degree of cleaning and cutting specifications during the pretreatment of medicinal materials to ensure the purity of the medicinal materials and the appropriate extraction size; Precisely control the soaking time, extraction method, extraction times and extraction time during the extraction process to fully extract the active ingredients in the medicinal materials while avoiding over-extraction or under-extraction; Reasonable selection of concentration methods and parameters to ensure the concentration and quality of the concentrate while reducing the loss of active ingredients; Select appropriate drying methods and parameters according to the properties of medicinal materials and product requirements to ensure the quality and stability of dry paste powder; During the granulation process, the selection and dosage of auxiliary materials, the type and dosage of wetting agents, the hardness of soft materials, the granulation method and parameters, the drying temperature and time, and the specifications of the whole granules are strictly controlled to ensure the formability, solubility, size uniformity and quality stability of the granules; Taking into account the diversity and complexity of medicinal materials, the specific production process may need to be adjusted and optimized according to actual conditions. In addition, since the preparation of Chinese medicine granules involves multiple links and complex technical requirements, it is recommended to carry out production under the guidance of professionals to ensure the safety, effectiveness and controllability of the production process.