Traditional Chinese medicine composition for treating kidney deficiency and phlegm stasis type lumbar intervertebral disc protrusion, preparation and application

Abstract

The invention relates to the field of traditional Chinese medicines, and particularly provides a traditional Chinese medicine composition for treating kidney deficiency and phlegm stasis type lumbar intervertebral disc protrusion, a preparation and application. The traditional Chinese medicine composition is prepared from the following components: schizophragma integrifolium, rhizoma dioscoreae nipponicae, herba pyrolae, cortex acanthopanacis, ground beetle, leech, rhizoma cyperi, rhizoma arisaematis, stiff silkworm, radix ranunculi ternati, antler, dog bone, astragalus membranaceus, angelica sinensis, radix paeoniae alba, sargentgloryvine stem, spina gleditsiae and liquorice. The traditional Chinese medicine composition formula has the multiple effects of promoting blood circulation to arrest pain, relaxing tendons and activating collaterals, promoting qi circulation and reducing phlegm, tonifying kidney and strengthening essence, strengthening tendons and bones and the like, LDH is treated in a multi-target and multi-channel mode, blood circulation of the waist is improved, metabolism is promoted, and therefore the degree of lumbocrural pain is relieved, and the lumbar vertebra function is enhanced. The traction relieves the intervertebral disc pressure by enlarging the width of the lumbar intervertebral space, relieves the nerve root pressure, and further improves the symptoms such as pain and numbness of the waist and the legs. Therefore, the application of the combined therapy disclosed by the invention can more effectively relieve the waist and leg pain degree and dysfunction of the patient.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, preparation and application for treating lumbar disc herniation of the kidney deficiency and phlegm stasis type. Background Technology

[0002] Lumbar disc herniation (LDH) is a common and frequently occurring clinical condition, primarily affecting young adults aged 20-50. With rapid advancements in modern technology, changes in work patterns, and unhealthy lifestyles, the incidence of LDH is steadily increasing, and the age of onset is gradually becoming younger. Modern medical treatment for LDH includes conservative and surgical approaches. Conservative treatment commonly utilizes medications such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, anesthetics, dehydrating agents, and neurotrophic drugs. While these medications can effectively relieve symptoms, they also have certain side effects, treating the symptoms but not the root cause. Long-term use may even lead to other complications, such as stomach pain, gastrointestinal bleeding, abnormal liver and kidney function, and fluctuations in blood pressure and blood sugar. Surgical treatment is not only high-risk and expensive but also causes significant trauma to the patient. Crucially, the possibility of recurrence is often relatively high.

[0003] In view of this, the purpose of this invention is to provide a traditional Chinese medicine composition, preparation, and application for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type, thereby overcoming the shortcomings of the prior art. In this traditional Chinese medicine composition, the various raw material components work synergistically to effectively reduce the pain level of LDH patients, improve lumbar spine function, and enhance their quality of life. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition, preparation, and application for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type. The traditional Chinese medicine composition comprises the following components: *Dendrobium nobile*, *Dioscorea nipponica*, *Pyrola rotundifolia*, *Acanthopanax senticosus*, *Eupolyphaga sinensis*, *Hirudo medicinalis*, *Cyperus rotundus*, *Arisaema heterophyllum*, *Bombyx mori*, *Uncaria rhynchophylla*, deer antler, dog bone, *Astragalus membranaceus*, *Angelica sinensis*, *Paeonia lactiflora*, *Sargentodoxa cuneata*, *Gleditsia sinensis* thorns, and licorice.

[0005] In one embodiment of the present invention, the traditional Chinese medicine composition comprises the following components by weight: 5-15 parts of *Dioscorea nipponica*, 5-15 parts of *Dioscorea nipponica*, 10-20 parts of *Pyrola rotundifolia*, 10-20 parts of *Acanthopanax senticosus*, 5-10 parts of *Eupolyphaga sinensis*, 5-10 parts of *Hirudo medicinalis*, 5-15 parts of *Cyperus rotundus*, 5-15 parts of *Arisaema heterophyllum*, 3-9 parts of *Bombyx mori*, 5-15 parts of *Cyperus rotundus*, 4-10 parts of *Deer antler*, 5-15 parts of *Dog bone*, 25-35 parts of *Astragalus membranaceus*, 5-15 parts of *Angelica sinensis*, 20-35 parts of *Paeonia lactiflora*, 5-15 parts of *Spatholobus suberectus*, 5-15 parts of *Gleditsia sinensis*, and 3-10 parts of *Glycyrrhiza uralensis*.

[0006] In one embodiment of the present invention, the traditional Chinese medicine composition comprises the following components by weight: 12 parts of *Dendrobium nobile*, 12 parts of *Smilax china*, 15 parts of *Pyrola rotundifolia*, 15 parts of *Acanthopanax senticosus*, 6 parts of *Eupolyphaga sinensis*, 6 parts of *Hirudo medicinalis*, 12 parts of *Cyperus rotundus*, 6 parts of *Arisaema heterophyllum*, 6 parts of *Bombyx mori*, 9 parts of *Cyperus rotundus*, 6 parts of deer antler, 12 parts of dog bone, 30 parts of *Astragalus membranaceus*, 12 parts of *Angelica sinensis*, 30 parts of *Paeonia lactiflora*, 12 parts of *Smilax china*, 12 parts of *Gleditsia sinensis*, and 9 parts of licorice.

[0007] A second aspect of the present invention provides a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and / or pharmaceutically acceptable excipients.

[0008] As one embodiment of the present invention, the dosage form of the pharmaceutical preparation is selected from tablets, granules, capsules, powders or solutions.

[0009] A third aspect of the present invention provides a method for preparing the pharmaceutical formulation, the method comprising the following steps:

[0010] S01 classifies the components of the traditional Chinese medicine composition;

[0011] S02 involves extracting the components from the traditional Chinese medicine composition classified in step S01;

[0012] S03 involves preparing a pharmaceutical formulation from the components extracted in step S02.

[0013] In one embodiment of the present invention, step S01 is classified as follows:

[0014] Group A: *Dendrobium nobile*, *Smilax china*, *Pyrola rotundifolia*, and *Acanthopanax senticosus*. This group of herbs has the effects of dispelling wind and dampness, clearing the meridians and relieving pain, and is mainly used for lower back and leg pain caused by LDH.

[0015] Group B: Earthworm, Leech, Cyperus rotundus, Arisaema heterophyllum, Bombyx mori, and Uncaria rhynchophylla; This group of herbs has the effects of promoting blood circulation, clearing the meridians, resolving phlegm and dissipating nodules, regulating qi and relieving pain, and has a good effect on lower back and leg pain and numbness caused by LDH.

[0016] Group C: Deer antler, dog bone, astragalus, angelica, white peony root; This group of medicinal materials has the effects of strengthening muscles and bones, relaxing muscles and relieving pain, and has a good effect on lower back and leg pain, weakness and numbness caused by LDH.

[0017] Group D: Red vine, soapberry thorn, licorice; This group of medicinal materials has the effects of clearing heat and detoxifying, and harmonizing the properties of other medicines. In the prescription, they are mainly used to prevent warm and dry medicines from damaging Yin and to guide the medicine directly to the disease site.

[0018] In one embodiment of the present invention, step S02 is as follows: effective components are extracted from groups A to D respectively, and then they are mixed.

[0019] The fourth aspect of this invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type.

[0020] As one embodiment of the present invention, the specific application method is as follows:

[0021] The traditional Chinese medicine composition is combined with mechanical rehabilitation training. The specific dosage, administration cycle, administration method, and mechanical rehabilitation training plan are as follows:

[0022] Traditional Chinese medicine composition: Each gram of granules contains 0.75-0.80g of raw medicinal material. Take 15g orally twice a day. One course of treatment is 4 weeks, and a total of 3 courses of treatment are required.

[0023] Simultaneously, in conjunction with mechanical rehabilitation training, traction is performed using a YHZ-I type multifunctional traction bed (Zhangjiagang Huayu Medical Bed Factory, Jiangsu Province). The traction weight is 1 / 3 to 1 / 2 of the patient's body weight, depending on the patient's tolerance. The traction time is 20 minutes per session, 3 times per week, with 4 weeks constituting one course of treatment, for a total of 3 courses of treatment.

[0024] By adopting the above technical solution, the present invention has the following beneficial effects:

[0025] The traditional Chinese medicine composition of this invention has multiple effects, including promoting blood circulation and relieving pain, relaxing muscles and tendons, regulating qi and resolving phlegm, tonifying the kidneys and replenishing essence, and strengthening muscles and bones. It treats LDH through multiple targets and pathways, improving blood circulation in the lumbar region and promoting metabolism, thereby alleviating the severity of lower back and leg pain and enhancing lumbar spine function. Traction, by widening the intervertebral space, relieves pressure on the intervertebral discs and reduces nerve root compression, further improving symptoms such as lower back and leg pain and numbness. Therefore, the combined therapy of this invention can more effectively alleviate the severity of lower back and leg pain and functional impairment in patients. Attached Figure Description

[0026] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0027] Figure 1 Comparison of TCM symptom scores between the treatment group and the control group;

[0028] Figure 2 Comparison of Japanese Orthopaedic Association (JOA) scores between the treatment group and the control group;

[0029] Figure 3Comparison of Oswestry Disability Index (ODI) scores between the treatment group and the control group. Detailed Implementation

[0030] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] The purpose of this invention is to provide a traditional Chinese medicine composition, preparation, and application for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type. The traditional Chinese medicine composition comprises the following components: *Dendrobium nobile*, *Dioscorea nipponica*, *Pyrola rotundifolia*, *Acanthopanax senticosus*, *Eupolyphaga sinensis*, *Hirudo medicinalis*, *Cyperus rotundus*, *Arisaema heterophyllum*, *Bombyx mori*, *Uncaria rhynchophylla*, deer antler, dog bone, *Astragalus membranaceus*, *Angelica sinensis*, *Paeonia lactiflora*, *Sargentodoxa cuneata*, *Gleditsia sinensis* thorns, and licorice.

[0032] In one embodiment of the present invention, the traditional Chinese medicine composition comprises the following components by weight: 5-15 parts of *Dioscorea nipponica*, 5-15 parts of *Dioscorea nipponica*, 10-20 parts of *Pyrola rotundifolia*, 10-20 parts of *Acanthopanax senticosus*, 5-10 parts of *Eupolyphaga sinensis*, 5-10 parts of *Hirudo medicinalis*, 5-15 parts of *Cyperus rotundus*, 5-15 parts of *Arisaema heterophyllum*, 3-9 parts of *Bombyx mori*, 5-15 parts of *Cyperus rotundus*, 4-10 parts of *Deer antler*, 5-15 parts of *Dog bone*, 25-35 parts of *Astragalus membranaceus*, 5-15 parts of *Angelica sinensis*, 20-35 parts of *Paeonia lactiflora*, 5-15 parts of *Spatholobus suberectus*, 5-15 parts of *Gleditsia sinensis*, and 3-10 parts of *Glycyrrhiza uralensis*.

[0033] In one embodiment of the present invention, the traditional Chinese medicine composition comprises the following components by weight: 12 parts of *Dendrobium nobile*, 12 parts of *Smilax china*, 15 parts of *Pyrola rotundifolia*, 15 parts of *Acanthopanax senticosus*, 6 parts of *Eupolyphaga sinensis*, 6 parts of *Hirudo medicinalis*, 12 parts of *Cyperus rotundus*, 6 parts of *Arisaema heterophyllum*, 6 parts of *Bombyx mori*, 9 parts of *Cyperus rotundus*, 6 parts of deer antler, 12 parts of dog bone, 30 parts of *Astragalus membranaceus*, 12 parts of *Angelica sinensis*, 30 parts of *Paeonia lactiflora*, 12 parts of *Smilax china*, 12 parts of *Gleditsia sinensis*, and 9 parts of licorice.

[0034] In the traditional Chinese medicine composition of this invention, two herbs, *Zuandifeng* and *Chuanshanlong*, are used as principal herbs, which have the effects of dispelling wind and dampness, relaxing muscles and tendons, promoting blood circulation and relieving pain. *Zuandifeng* is bitter and cool in nature, and enters the spleen and stomach meridians. It has the effects of dispelling wind and dampness, promoting blood circulation and relieving pain, and detoxifying and reducing swelling. It can dispel wind and dampness and unblock the meridians, and is mainly used to treat rheumatic pain, soreness of the limbs and joints, and other diseases. *Chuanshanlong* is sweet and bitter in taste, warm in nature, and enters the liver, kidney, and lung meridians. It has the effects of dispelling wind and dampness, unblocking the meridians and relieving pain, promoting blood circulation and removing blood stasis, and relieving cough and asthma. It can dispel wind and unblock the meridians, promote blood circulation and relieve pain. It is mainly used to treat pain, swelling, numbness of the limbs and joints caused by rheumatic arthralgia, and pain caused by falls and injuries. The formula uses six herbs—earthworm, leech, cyperus, arisaema, silkworm, and cat's claw grass—as assistant herbs. These herbs have the effects of promoting blood circulation, removing blood stasis, regulating qi, and resolving phlegm. Among them, earthworm and leech are particularly good at breaking up blood stasis and clearing the meridians; arisaema, silkworm, and cat's claw grass have the effects of resolving phlegm and dissipating nodules, with arisaema being especially good at removing phlegm from the meridians; silkworm also has the effect of clearing the meridians and relieving pain; cat's claw grass also has the effect of detoxifying and reducing swelling; cyperus is good at regulating qi and blood circulation, achieving the goal of "when qi flows, blood flows; when qi is smooth, phlegm disappears." These six herbs work together to clear phlegm and blood stasis in the meridians, thereby achieving the goal of "where there is free flow, there is no pain," and together they serve as assistant herbs. This formula uses seven herbs—deer antler, dog bone, deer antler grass, eleutherococcus senticosus bark, astragalus, angelica sinensis, and white peony root—as adjuvants. It has the effects of tonifying the kidneys and strengthening bones, replenishing blood and essence, and strengthening tendons and bones. Deer antler warms the kidney yang, replenishes essence and blood, and strengthens tendons and bones, primarily used to treat weakness and soreness in the lower back and knees caused by kidney yang deficiency. Dog bone strengthens tendons and bones, dispels wind and unblocks meridians, and relieves pain; it is a key medicine for symptoms such as malnourishment of tendons and bones, weakness in the lower back and knees, and rheumatic pain caused by liver and kidney deficiency. Deer antler grass dispels wind and dampness, unblocks meridians, tonifies the liver and kidneys, and strengthens tendons and bones, providing both symptomatic and root-cause treatment for lower back, knee, and limb pain caused by liver and kidney deficiency and rheumatic obstruction. Eleutherococcus senticosus bark... Not only can it dispel rheumatism, thus relieving pain, but it can also nourish the liver and kidneys. When the liver and kidneys are strong, the tendons and bones are healthy. Therefore, it has become an essential medicine for treating liver and kidney deficiency and rheumatic pain. Astragalus is an essential medicine for replenishing qi, supporting the body's resistance to pathogens, promoting blood circulation, and enhancing the function of qi and blood production. Angelica can not only replenish blood, promote blood circulation, and relieve pain, but also moisten the intestines and promote bowel movements, allowing pathogens to be expelled through defecation. White peony nourishes blood, astringes yin, softens the liver, and relieves pain. Astragalus, Angelica, and white peony work together to replenish qi and nourish blood. Since essence and blood share the same origin, when qi and blood are abundant, kidney essence is sufficient and tendons and bones are strong. Together with Pyrola rotundifolia, Acanthopanax senticosus, deer antler, and dog bone, it nourishes the essence and blood of the liver and kidneys, strengthens tendons and bones, relaxes muscles and relieves pain. They are all adjuvant medicines. Using red vine, soapberry thorn, and licorice as guiding herbs, this formula clears heat and detoxifies, and harmonizes the properties of other herbs. Red vine has the effects of clearing heat and detoxifying, dispelling wind and relieving pain; soapberry thorn has the effects of dispelling wind and unblocking the meridians, reducing swelling and detoxifying; and licorice has the effect of moderating the properties of other herbs and harmonizing the spleen and stomach. The combined effects of these herbs are to invigorate blood circulation, unblock the meridians, dispel dampness and resolve phlegm, and tonify the kidneys and strengthen bones. Due to its significant clinical efficacy, it is highly favored by patients.

[0035] A second aspect of the present invention provides a pharmaceutical preparation comprising the aforementioned traditional Chinese medicine composition and / or pharmaceutically acceptable excipients.

[0036] As one embodiment of the present invention, the dosage form of the pharmaceutical preparation is selected from tablets, granules, capsules, powders or solutions.

[0037] The compositions described in this invention can be administered via various routes, such as oral tablets, capsules, powders, oral liquids, injections, and transdermal formulations. According to conventional pharmaceutical practice, pharmaceutically acceptable carriers include diluents, fillers, disintegrants, wetting agents, lubricants, colorants, flavoring agents, or other conventional additives. Typical pharmaceutically acceptable carriers include, for example, microcrystalline cellulose, starch, crosslinked povidone, povidone, polyvinylpyrrolidone, maltitol, citric acid, sodium dodecyl sulfate, or magnesium stearate.

[0038] A third aspect of the present invention provides a method for preparing the pharmaceutical formulation, the method comprising the following steps:

[0039] S01 classifies the components of the traditional Chinese medicine composition;

[0040] S02 involves decocting and extracting the components from the traditional Chinese medicine composition classified in step S01.

[0041] S03 involves preparing a pharmaceutical formulation from the components extracted in step S02.

[0042] In one embodiment of the present invention, step S01 is classified as follows:

[0043] Group A: *Dendrobium nobile*, *Smilax china*, *Pyrola rotundifolia*, and *Acanthopanax senticosus*. This group of herbs has the effects of dispelling wind and dampness, clearing the meridians and relieving pain, and is mainly used for lower back and leg pain caused by LDH.

[0044] Group B: Earthworm, Leech, Cyperus rotundus, Arisaema heterophyllum, Bombyx mori, and Uncaria rhynchophylla; This group of herbs has the effects of promoting blood circulation, clearing the meridians, resolving phlegm and dissipating nodules, regulating qi and relieving pain, and has a good effect on lower back and leg pain and numbness caused by LDH.

[0045] Group C: Deer antler, dog bone, astragalus, angelica, white peony root; This group of medicinal materials has the effects of strengthening muscles and bones, relaxing muscles and relieving pain, and has a good effect on lower back and leg pain, weakness and numbness caused by LDH.

[0046] Group D: Red vine, soapberry thorn, licorice; This group of medicinal materials has the effects of clearing heat and detoxifying, and harmonizing the properties of other medicines. In the prescription, they are mainly used to prevent warm and dry medicines from damaging Yin and to guide the medicine directly to the disease site.

[0047] In one embodiment of the present invention, step S02 is as follows: effective components are extracted from groups A to D respectively, and then they are mixed.

[0048] As one embodiment of the present invention, the method for preparing the pharmaceutical preparation specifically includes the following steps:

[0049] (1) Soak the components of group A in water for 1-1.5 hours, then decoct them 3 times. Add 8 times the amount of water for the first time, and 6 times the amount of water for the second and third times. Each time, decoct for 1 hour, filter, and combine the filtrates to obtain medicine solution A.

[0050] After soaking the components of group B in water for 1-1.5 hours, decoct them 3 times. Add 10 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Each time, decoct for 1 hour, filter, and combine the filtrates to obtain medicine solution B.

[0051] After soaking the components of group C in water for 2-2.5 hours, decoct them 3 times. Add 15 times the amount of water for the first time, and 12 times the amount of water for the second and third times. Each time, decoct for 2 hours, filter, and combine the filtrates to obtain medicinal solution C.

[0052] Soak the components of group D in water for 1-1.5 hours, then decoct them 3 times. Add 10 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Each time, decoct for 1 hour, filter, and combine the filtrates to obtain medicinal solution D.

[0053] (2) Mix the prepared drug solutions A, B, and D, and concentrate the mixed drug solution to 1 / 3-1 / 2 of the original volume to obtain ointment A; at the same time, concentrate drug solution C separately to ointment B with a relative density of 1.05-1.10 (70-80℃); stir and mix ointment A and ointment B and concentrate to a clear ointment with a relative density of 1.15-1.20 (70-80℃); dry under reduced pressure, pulverize, and sieve.

[0054] (3) Add excipients (such as dextrin, starch, etc.) and flavoring agents (such as stevioside, sucrose, etc.), mix well, granulate, and dry. The resulting granules contain 0.75-0.80g of crude drug per gram of granules.

[0055] The fourth aspect of this invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a drug for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type.

[0056] As one embodiment of the present invention, the specific application method is as follows:

[0057] The traditional Chinese medicine composition is combined with mechanical rehabilitation training. The specific dosage, administration cycle, administration method, and mechanical rehabilitation training plan are as follows:

[0058] Traditional Chinese medicine composition: Each gram of granules contains 0.75-0.80g of raw medicinal material. Take 15g orally twice a day. One course of treatment is 4 weeks, and a total of 3 courses of treatment are required.

[0059] Simultaneously, in conjunction with mechanical rehabilitation training, traction is performed using a YHZ-I type multifunctional traction bed (Zhangjiagang Huayu Medical Bed Factory, Jiangsu Province). The traction weight is 1 / 3 to 1 / 2 of the patient's body weight, depending on the patient's tolerance. The traction time is 20 minutes per session, 3 times per week, with 4 weeks constituting one course of treatment, for a total of 3 courses of treatment.

[0060] This invention relates to a traditional Chinese medicine composition that fully embodies the profound understanding and unique treatment methods of traditional Chinese medicine for lumbar disc herniation. This herbal formula follows the principles of syndrome differentiation and treatment in traditional Chinese medicine, targeting lumbar disc herniation of the kidney deficiency and phlegm-stasis type, employing multiple treatment methods such as promoting blood circulation and unblocking collaterals, eliminating dampness and resolving phlegm, and tonifying the kidneys and strengthening bones. The four herbs in the formula—*Zuan Di Feng*, *Chuan Shan Long*, *Lu Xian Cao*, and *Wu Jia Pi*—have the effects of dispelling wind and dampness, unblocking collaterals, and relieving pain. They mainly treat symptoms such as lower back and leg pain, muscle soreness, and numbness caused by rheumatic obstruction by regulating the immune system, inhibiting inflammatory responses, and improving blood circulation. The synergistic application of these herbs significantly enhances the overall effect of the formula. The three herbs—*Tu Yuan*, *Shui Zhi*, and *Xiang Fu*—have the effects of promoting blood circulation, removing blood stasis, regulating qi, and relieving pain; they mainly treat symptoms such as lower back and leg pain and numbness caused by blood stasis by promoting local blood circulation, accelerating metabolism, and unblocking qi and blood. The three herbs, Arisaema heterophyllum, Bombyx mori, and Uncaria rhynchophylla, have the effect of resolving phlegm and dissipating nodules. They exert their synergistic effect mainly through reducing inflammatory responses, anti-oxidative stress, and regulating immune function, and are effective for treating lower back and leg pain, muscle soreness, and numbness caused by phlegm and dampness. The five herbs, deer antler, dog bone, as well as Astragalus membranaceus, Angelica sinensis, and Paeonia lactiflora, have the effect of tonifying the liver and kidneys, replenishing essence and blood, and strengthening tendons and bones. They can effectively replenish kidney essence, promote bone growth and repair, enhance bone strength and toughness, strengthen the muscles and ligaments around the spine, and have a special effect on improving symptoms such as lower back and knee weakness and recurrent attacks caused by kidney deficiency. Red vine and Gleditsia sinensis thorns have the effect of dispelling wind and unblocking meridians, guiding the medicine directly to the affected area. Licorice has the effect of clearing heat and detoxifying, and harmonizing the properties of other herbs. These herbs can enhance the overall efficacy of the formula. In summary, the formula for treating lumbar disc herniation (especially for lumbar disc herniation of the kidney deficiency and phlegm-stasis type) of this invention embodies the unique concepts and rich experience of traditional Chinese medicine in the treatment of lumbar disc herniation, and plays a positive role in improving patients' symptoms and quality of life. This invention maximizes the efficacy of the medicine by leveraging the advantages of each component and avoiding its disadvantages, based on the characteristics of the components.

[0061] The present invention will be further explained below with reference to specific embodiments.

[0062] Example 1

[0063] This embodiment provides a traditional Chinese medicine preparation composed of the following components: 12g of *Zuan Di Feng*, 12g of *Chuan Shan Long*, 15g of *Lu Xian Cao*, 15g of *Wu Jia Pi*, 6g of *Tu Yuan*, 6g of *Shui Zhi*, 12g of *Xiang Fu*, 6g of *Tian Nan Xing*, 6g of *Jiang Can*, 9g of *Mao Zhua Cao*, 6g of *Lu Jiao*, 12g of *Gou Gu*, 30g of *Huang Qi*, 12g of *Dang Gui*, 30g of *Bai Shao*, 12g of *Hong Teng*, 12g of *Zao Jiao Ci*, and 9g of *Gan Cao*.

[0064] And the groups are as follows:

[0065] Group A: *Drilling Wind*, *Smilax china*, *Deer-head Grass*, *Acanthopanax senticosus*;

[0066] Group B: Earthworm, Leech, Cyperus rotundus, Arisaema heterophyllum, Bombyx mori, Cat's Claw Herb;

[0067] Group C: Deer antler, dog bone, astragalus, angelica, and white peony root; among them, deer antler and dog bone need to be pre-treated and crushed (particle size ≤1cm);

[0068] Group D: Red vine, soapberry thorn, licorice.

[0069] The preparation method is as follows:

[0070] (1) Soak the components of group A in water for 1.5 hours, then decoct them 3 times. Add 8 times the amount of water for the first time, and 6 times the amount of water for the second and third times. Each time, decoct for 1 hour, filter, and combine the filtrates to obtain medicine solution A.

[0071] After soaking the components of group B in water for 1.5 hours, decoct them three times. Add 10 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Each time, decoct for 1 hour, filter, and combine the filtrates to obtain medicine solution B.

[0072] After soaking the components of group C in water for 2.5 hours, decoct them three times. Add 15 times the amount of water for the first time, and 12 times the amount of water for the second and third times. Each time, decoct for 2 hours, filter, and combine the filtrates to obtain medicinal solution C.

[0073] After soaking the components of group D in water for 1.5 hours, decoct them three times. Add 10 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Each time, decoct for 1 hour, filter, and combine the filtrates to obtain medicinal solution D.

[0074] (2) Mix the prepared drug solutions A, B, and D, and concentrate the mixed drug solution to 1 / 3-1 / 2 of the original volume to obtain ointment A; at the same time, concentrate drug solution C separately to ointment B with a relative density of 1.05-1.10 (70-80℃); stir and mix ointment A and ointment B and concentrate to a clear ointment with a relative density of 1.15-1.20 (70-80℃); dry under reduced pressure, pulverize, and sieve.

[0075] (3) Add excipients (such as dextrin, starch, etc.) and flavoring agents (such as stevioside, sucrose, etc.), mix well, granulate, and dry. The resulting granules contain 0.75-0.80g of crude drug per gram of granules.

[0076] Example 2

[0077] This embodiment provides a traditional Chinese medicine preparation composed of the following components: 10g of *Zuan Di Feng*, 10g of *Chuan Shan Long*, 10g of *Lu Xian Cao*, 10g of *Wu Jia Pi*, 9g of *Tu Yuan*, 9g of *Shui Zhi*, 10g of *Xiang Fu*, 10g of *Tian Nan Xing*, 3g of *Jiang Can*, 10g of *Mao Zhua Cao*, 10g of *Lu Jiao*, 10g of *Gou Gu*, 35g of *Huang Qi*, 9g of *Dang Gui*, 25g of *Bai Shao*, 10g of *Hong Teng*, 10g of *Zao Jiao Ci*, and 3g of *Gan Cao*.

[0078] The drug components and preparation methods of the traditional Chinese medicine preparation are the same as in Example 1.

[0079] Example 3

[0080] This embodiment provides a traditional Chinese medicine preparation composed of the following components: 15g of *Zuan Di Feng*, 15g of *Chuan Shan Long*, 12g of *Lu Xian Cao*, 12g of *Wu Jia Pi*, 10g of *Tu Yuan*, 10g of *Shui Zhi*, 15g of *Xiang Fu*, 9g of *Tian Nan Xing*, 9g of *Jiang Can*, 12g of *Mao Zhua Cao*, 6g of *Lu Jiao*, 10g of *Gou Gu*, 25g of *Huang Qi*, 15g of *Dang Gui*, 20g of *Bai Shao*, 9g of *Hong Teng*, 9g of *Zao Jiao Ci*, and 6g of *Gan Cao*.

[0081] The drug components and preparation methods of the traditional Chinese medicine preparation are the same as in Example 1.

[0082] Application Examples

[0083] The clinical efficacy of the traditional Chinese medicine composition disclosed in this invention was tracked, and the treatment process and results are as follows:

[0084] 1. Clinical treatment methods

[0085] 1.1 Patient Information

[0086] From January 2023 to June 2024, 80 patients with lumbar disc herniation (LDH) were selected. Inclusion criteria: ① Meeting the diagnostic criteria for lumbar disc herniation in the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine" promulgated by the State Administration of Traditional Chinese Medicine in 1994; ② Age between 20 and 60 years, regardless of gender; ③ Disease duration of 1-12 months; ④ VAS score > 4; ⑤ Agreeing to the trial observation and signing an informed consent form. Exclusion criteria: ① Urinary and fecal incontinence, severe lower limb muscle weakness requiring surgical treatment; ② Imaging examination showing lumbar disc herniation or detachment; ③ Concurrent lumbar tuberculosis, fracture, or tumor; ④ Severe hypertension, osteoporosis, mental illness, coagulation disorders, etc. Grouping was done by random number table, with 40 patients in the control group and 40 patients in the treatment group. There were no statistically significant differences in gender, age, and disease duration between the two groups (P > 0.05), as shown in Table 1.

[0087] Table 1 Comparison of general data between the two groups

[0088]

[0089] 1.2 Treatment methods

[0090] 1.2.1 The control group used a YHZ-I type multifunctional traction bed (Zhangjiagang Huayu Medical Bed Factory, Jiangsu Province) for traction. The traction weight was 1 / 3 to 1 / 2 of the patient's body weight, depending on the patient's tolerance, for 20 minutes per session, 3 times per week, for 4 weeks as one course of treatment. A total of 3 courses of treatment were performed.

[0091] 1.2.1 The treatment group received additional treatment to the control group, along with the herbal composition of this invention: *Zuan Di Feng* (12g), *Chuan Shan Long* (12g), *Lu Xian Cao* (15g), *Wu Jia Pi* (15g), *Tu Yuan* (6g), *Shui Zhi* (6g), *Xiang Fu* (12g), *Tian Nan Xing* (6g), *Jiang Can* (6g), *Mao Zhua Cao* (9g), *Lu Jiao* (6g), *Gou Gu* (12g), *Huang Qi* (30g), *Dang Gui* (12g), *Bai Shao* (30g), *Hong Teng* (12g), *Zao Jiao Ci* (12g), and *Gan Cao* (9g). Granules were prepared using the method described in Example 1, stored in a light-proof, sealed container, and taken with warm water, 15g twice daily after breakfast and dinner. One course of treatment lasted four weeks, and three courses were administered. The traction time, weight, and course of treatment were the same as the control group.

[0092] 1.3 Efficacy evaluation and observation indicators

[0093] 1.3.1 Evaluation of therapeutic effect

[0094] The treatment criteria for lumbar disc herniation, as defined in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases" promulgated by the State Administration of Traditional Chinese Medicine in 1994, are as follows: Cured: Disappearance of lower back and leg pain, straight leg raise of 70 degrees. 0 The above results indicate the following: Able to return to work; Improved: Lower back and leg pain lessened, and lumbar mobility improved; Not cured: No improvement in symptoms or signs.

[0095] 1.3.2 Traditional Chinese Medicine (TCM) Symptom Score: Primary symptoms include lower back pain, limb pain / numbness, and limited lumbar mobility, scored as 0, 2, 4, and 6 points respectively (none, mild, moderate, severe). Secondary symptoms include lower back and knee weakness, limb heaviness, tingling pain worsening at night, tongue appearance, and pulse, scored as 0, 1, 2, and 3 points respectively. The total TCM symptom score is calculated to assess the patient's condition.

[0096] 1.3.3 Inflammatory factor assay: The changes in serum interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) expression levels were measured using enzyme-linked immunosorbent assay (ELISA).

[0097] 1.3.4 Assessment of pain intensity, lumbar spine function, and quality of life: The visual analogue scale (VAS) (0-10 points) was used to assess the intensity of low back and leg pain in the selected cases; the Japanese Orthopaedic Association (JOA) scoring criteria were used to assess the lumbar spine function of the selected cases; and the Oswestry Disability Index (ODI) was used to assess the quality of life of the selected cases.

[0098] 1.4 Data Statistics and Analysis

[0099] Clinical data from both groups before and after treatment were collected by a specialized statistician. Appropriate statistical methods were selected based on the nature of the data; for measurement data, mean ± standard deviation was used. This indicates that a t-test is used, and χ² is used for count data. 2 For ordinal data, the rank-sum test was used. All data were analyzed using Excel and SPSS 22.0 statistical software.

[0100] 2. Experimental Results

[0101] 2.1 Comparison of comprehensive therapeutic effects between the two groups

[0102] After three courses of treatment, the total effective rate in the treatment group was 90.00%, which was higher than the total effective rate in the control group (75.00%), and the difference was statistically significant (P<0.05). See Table 2 for details.

[0103] Table 2 Comparison of overall therapeutic effects between the two groups [n(%)]

[0104]

[0105]

[0106] 2.2 Comparison of TCM syndrome scores between the two groups

[0107] Before treatment, there was no statistically significant difference in TCM syndrome scores between the two groups (P>0.05). At 6 and 12 weeks after treatment, the TCM syndrome scores of both groups decreased compared with before treatment (P<0.01), and the scores of the treatment group were lower than those of the control group (P<0.05). See Table 3 for details.

[0108] Table 3 Comparison of TCM syndrome scores between the two groups

[0109]

[0110] Note: a P<0.05 compared with before treatment, b P<0.05 compared with the control group.

[0111] 2.3 Comparison of inflammatory factors between the two groups

[0112] Before treatment, there were no statistically significant differences in IL-6 and TNF-α scores between the two groups (P>0.05). At 6 and 12 weeks after treatment, IL-6 and TNF-α scores in both groups decreased compared to before treatment (P<0.01), and the scores in the treatment group were lower than those in the control group (P<0.05). See Table 4 for details.

[0113] Table 4 Comparison of IL-6 and TNF-α expression levels between the two groups

[0114]

[0115] Note: a P<0.05 compared with before treatment, b P<0.05 compared with the control group

[0116] 2.4 Comparison of pain intensity (VAS), lumbar spine function (JOA), and quality of life (ODI) between the two groups

[0117] Before treatment, there were no statistically significant differences in VAS, JOA, and ODI scores between the two groups (P>0.05). At 6 and 12 weeks after treatment, VAS and ODI scores in both groups decreased compared to before treatment (P<0.01), with the treatment group showing lower scores than the control group (P<0.05). At 6 and 12 weeks after treatment, JOA scores in both groups increased compared to before treatment (P<0.01), with the treatment group showing higher scores than the control group (P<0.05). See Table 5 for details.

[0118] Table 5 Comparison of VAS, JOA, and ODI scores between the two groups of patients

[0119]

[0120] Note: a P<0.05 compared with before treatment, bP<0.05 compared with the control group

[0121] 3. Conclusion

[0122] Lumbar disc herniation (LDH) is a common and frequently occurring clinical disease. With changes in lifestyle, its incidence is rising year by year, and it is showing a trend towards affecting younger and more young people, becoming one of the major diseases impacting people's health and quality of life. Currently, while Western medicine treatments for LDH can alleviate symptoms to some extent, long-term use easily leads to drug resistance, adverse reactions, and other problems, and it is difficult to cure completely.

[0123] The traditional Chinese medicine composition of this invention is a granule made from a mixture of various Chinese medicinal herbs. The principal herbs are *Dendrobium nobile* and *Dioscorea nipponica*, which promote blood circulation, relieve pain, and remove blood stasis. By inhibiting inflammatory responses and improving blood circulation, they effectively treat lower back and leg pain caused by LDH. The assistant herbs are *Eupolyphaga sinensis*, *Hirudo medicinalis*, *Cyperus rotundus*, *Arisaema heterophyllum*, *Bombyx mori*, and *Uncaria rhynchophylla*, which promote blood circulation, remove blood stasis, regulate qi, resolve phlegm, reduce inflammatory responses, resist oxidative stress, and regulate immune function. They have a good therapeutic effect on lower back and leg pain, muscle soreness, and numbness caused by phlegm and blood stasis.

[0124] Seven herbs—deer antler, dog bone, deer antler grass, eleutherococcus senticosus bark, astragalus, angelica sinensis, and white peony root—serve as adjuvant herbs to tonify the kidneys and strengthen bones, replenish blood and essence, strengthen tendons and bones, enhance the body's vital energy, improve immunity, promote bone growth and repair, and strengthen muscles and ligaments. This effectively treats symptoms such as lower back and knee weakness and recurrent episodes caused by kidney deficiency. Red vine, soapberry thorns, and licorice root serve as guiding herbs to clear heat and detoxify, harmonize the properties of the herbs, and direct the medicine directly to the affected area, enhancing the overall efficacy of the formula.

[0125] The traditional Chinese medicine composition formula of this invention has multiple effects, including clearing the meridians and relieving pain, promoting blood circulation and removing blood stasis, regulating qi and resolving phlegm, and tonifying the kidneys and strengthening bones. It can comprehensively regulate the body and improve the condition from multiple levels. Therefore, combining conventional Western medicine traction therapy with the traditional Chinese medicine formula of this invention can leverage the complementary advantages of both Chinese and Western medicine to improve the therapeutic effect. The traditional Chinese medicine ingredients in the formula of this invention can holistically regulate TCM syndromes such as kidney deficiency and phlegm stasis, improving symptoms such as lower back and leg pain and limited mobility in patients. At the same time, traction widens the intervertebral space, reduces nerve root compression, and improves symptoms such as lower back and leg pain and numbness. The results of the TCM syndrome scoring research of this invention show (e.g.) Figure 1 As shown in the figure: Before treatment, there was no statistically significant difference in TCM symptom scores between the two groups (P>0.05). At 6 and 12 weeks after treatment, the TCM symptom scores of both groups decreased compared to before treatment (P<0.01), and the treatment group had significantly lower scores than the control group (P<0.05). This clearly demonstrates that the combined treatment of LDH with the formula of this invention is superior to traction therapy alone, and can more comprehensively improve the patient's TCM symptoms and reduce the TCM symptom score.

[0126] The traditional Chinese medicine components in the formula of this invention can regulate the body's immune function, inhibit the production and release of inflammatory factors, and reduce inflammatory responses. The results of the inflammatory factor assay in this invention showed that before treatment, there was no statistically significant difference in IL-6 and TNF-α scores between the two groups (P>0.05). At 6 and 12 weeks after treatment, the IL-6 and TNF-α scores in both groups were significantly lower than before treatment (P<0.01), and the treatment group showed significantly lower scores than the control group (P<0.05). This clearly demonstrates that the combined treatment of LDH with traction and the formula of this invention is superior to traction alone, and has a greater advantage in reducing inflammatory factor levels.

[0127] The traditional Chinese medicine composition of this invention possesses multiple effects, including dispelling wind and relieving pain, promoting blood circulation and unblocking collaterals, eliminating dampness and resolving phlegm, and tonifying the kidneys and strengthening bones. These effects reflect the holistic concept of disease treatment in traditional Chinese medicine, namely, achieving the purpose of treating diseases by regulating the body's yin-yang balance and qi and blood circulation. The formula holistically regulates traditional Chinese medicine syndromes such as phlegm and blood stasis and kidney deficiency, reflecting the profound understanding of etiology and pathogenesis in traditional Chinese medicine. By improving symptoms such as lower back and leg pain and limited mobility, the traditional Chinese medicine formula plays an important role in improving patients' quality of life. Conventional Western medicine treatment usually focuses on rapid symptom relief and disease control, while traditional Chinese medicine emphasizes holistic regulation and the maintenance of long-term effects. Combining the two can fully utilize their respective advantages to maximize the therapeutic effect. The results of VAS, JOA, and ODI score studies of this invention show (e.g.) Figure 2 , Figure 3 As shown in the figure: Before treatment, there were no statistically significant differences in VAS, JOA, and ODI scores between the two groups (P>0.05). At 6 and 12 weeks after treatment, VAS and ODI scores in both groups decreased compared to before treatment (P<0.01), and the treatment group had lower scores than the control group (P<0.05); at 6 and 12 weeks after treatment, JOA scores in both groups increased compared to before treatment (P<0.01), and the treatment group had higher scores than the control group (P<0.05), which were statistically significant. This fully demonstrates that the combined treatment of LDH with the formula of this invention is superior to traction treatment alone, and has greater advantages in relieving low back and leg pain, improving lumbar spine function, and improving patients' quality of life.

[0128] The traditional Chinese medicine composition of this invention has multiple effects, including promoting blood circulation and relieving pain, relaxing muscles and tendons, regulating qi and resolving phlegm, tonifying the kidneys and replenishing essence, and strengthening muscles and bones. It treats LDH through multiple targets and pathways, improving blood circulation in the lumbar region and promoting metabolism, thereby alleviating the severity of lower back and leg pain and enhancing lumbar spine function. Traction, by widening the intervertebral space, relieves pressure on the intervertebral discs and reduces nerve root compression, further improving symptoms such as lower back and leg pain and numbness. Therefore, the combined application of these two treatment methods can more effectively alleviate the severity of lower back and leg pain and functional impairment in patients.

[0129] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type, characterized in that, The traditional Chinese medicine composition includes the following components: *Dendrobium nobile*, *Smilax china*, *Pyrola rotundifolia*, *Acanthopanax senticosus*, *Eupolyphaga sinensis*, *Hirudo medicinalis*, *Cyperus rotundus*, *Arisaema heterophyllum*, *Bombyx mori*, *Uncaria rhynchophylla*, deer antler, dog bone, *Astragalus membranaceus*, *Angelica sinensis*, *Paeonia lactiflora*, *Sargentodoxa cuneata*, *Gleditsia sinensis* thorns, and licorice.

2. The traditional Chinese medicine composition for treating lumbar disc herniation of kidney deficiency and phlegm-stasis type according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components by weight: 5-15 parts of *Dioscorea nipponica*, 5-15 parts of *Dioscorea nipponica*, 10-20 parts of *Pyrola rotundifolia*, 10-20 parts of *Acanthopanax senticosus*, 5-10 parts of *Eupolyphaga sinensis*, 5-10 parts of *Hirudo medicinalis*, 5-15 parts of *Cyperus rotundus*, 5-15 parts of *Arisaema heterophyllum*, 3-9 parts of *Bombyx mori*, 5-15 parts of *Cyperus rotundus*, 4-10 parts of *Deer antler*, 5-15 parts of *Dog bone*, 25-35 parts of *Astragalus membranaceus*, 5-15 parts of *Angelica sinensis*, 20-35 parts of *Paeonia lactiflora*, 5-15 parts of *Smilax china*, 5-15 parts of *Gleditsia sinensis*, and 3-10 parts of *Glycyrrhiza uralensis*.

3. The traditional Chinese medicine composition for treating lumbar disc herniation of kidney deficiency and phlegm-stasis type according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components: 12 parts of *Dendrobium nobile*, 12 parts of *Smilax china*, 15 parts of *Pyrola rotundifolia*, 15 parts of *Acanthopanax senticosus*, 6 parts of *Eupolyphaga sinensis*, 6 parts of *Hirudo medicinalis*, 12 parts of *Cyperus rotundus*, 6 parts of *Arisaema heterophyllum*, 6 parts of *Bombyx mori*, 9 parts of *Cyperus rotundus*, 6 parts of deer antler, 12 parts of dog bone, 30 parts of *Astragalus membranaceus*, 12 parts of *Angelica sinensis*, 30 parts of *Paeonia lactiflora*, 12 parts of *Smilax china*, 12 parts of *Gleditsia sinensis*, and 9 parts of licorice.

4. A pharmaceutical preparation, characterized in that, The pharmaceutical preparation comprises the traditional Chinese medicine composition according to any one of claims 1-3 and / or pharmaceutically acceptable excipients.

5. The pharmaceutical preparation according to claim 4, characterized in that, The dosage form of the pharmaceutical preparation is selected from tablets, granules, capsules, powders, or solutions.

6. The method for preparing the pharmaceutical formulation according to claim 4, characterized in that, The preparation method steps are as follows: S01 classifies the components of the traditional Chinese medicine composition; S02 involves extracting the components from the traditional Chinese medicine composition classified in step S01; S03 involves preparing a pharmaceutical formulation from the components extracted in step S02.

7. The method for preparing a pharmaceutical formulation according to claim 6, characterized in that, In step S01, the classification is as follows: Group A: *Drilling Wind*, *Smilax china*, *Deer-head Grass*, *Acanthopanax senticosus*; Group B: Earthworm, Leech, Cyperus rotundus, Arisaema heterophyllum, Bombyx mori, Cat's Claw Herb; Group C: Deer antler, dog bone, astragalus, angelica, white peony root; Group D: Red vine, soapberry thorn, licorice.

8. The method for preparing a pharmaceutical formulation according to claim 6, characterized in that, The specific steps of step S02 are as follows: extract the effective components from groups A to D respectively, and then mix them.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating lumbar disc herniation of the kidney deficiency and phlegm-stasis type.

10. The application according to claim 9, characterized in that, The specific application method is as follows: The traditional Chinese medicine composition is combined with mechanical rehabilitation training. The specific dosage, administration cycle, administration method, and mechanical rehabilitation training plan are as follows: Traditional Chinese medicine composition: Each gram of granules contains 0.75-0.80g of raw medicinal material. Take 15g twice daily, orally. One course of treatment lasts 4 weeks, for a total of 3 courses. Simultaneously, in conjunction with mechanical rehabilitation training, the YHZ-I type multifunctional traction bed is used for traction. The traction weight is 1 / 3 to 1 / 2 of the patient's body weight, depending on the patient's tolerance. The treatment lasts for 20 minutes per session, 3 times per week, with 4 weeks constituting one course of treatment. A total of 3 courses of treatment are administered.

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