A blood-nourishing and kidney-tonifying pill for treating lower back pain due to kidney yin deficiency.

Abstract

This invention discloses a blood-nourishing and kidney-tonifying pill for treating lower back pain due to kidney yin deficiency, prepared from the following Chinese medicinal herbs in parts by weight: 25-35 parts Rehmannia glutinosa, 20-30 parts Cornus officinalis, 18-22 parts Eucommia ulmoides, 15-25 parts Achyranthes bidentata, 20-30 parts Angelica sinensis, 22-30 parts Ligusticum chuanxiong, 20-28 parts Salvia miltiorrhiza, 15-25 parts Curcuma zedoaria, 20-30 parts Citrus reticulata peel, 10-20 parts Cyperus rotundus, 15-25 parts Bupleurum chinense, and 20-30 parts Atractylodes macrocephala. The formula contains 0 parts of Rehmannia glutinosa, 15-25 parts of Citrus aurantium, 18-22 parts of Amomum villosum, 20-30 parts of Scutellaria baicalensis, 15-25 parts of Morus alba root bark, 10-20 parts of bitter apricot kernel, and 15-25 parts of Eriobotrya japonica leaf. The whole formula contains Rehmannia glutinosa, Cornus officinalis, Eucommia ulmoides, Achyranthes bidentata, Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, Atractylodes macrocephala, Citrus aurantium, Amomum villosum, Scutellaria baicalensis, Morus alba root bark, bitter apricot kernel, and Eriobotrya japonica leaf. It nourishes blood and tonifies the kidneys to treat kidney yin deficiency and lower back pain, and its preparation method is disclosed.

Description

Technical Field

[0001] This application relates to the field of traditional Chinese medicine pharmaceutical technology, and in particular to a blood-nourishing and kidney-tonifying pill that treats kidney yin deficiency and lower back pain by nourishing blood and tonifying the kidney, and its preparation method. Background Technology

[0002] Lower back pain falls under the category of "lumbar arthralgia" in Traditional Chinese Medicine (TCM), also known as "lower back and leg pain" or "arthralgia syndrome" in ancient texts. According to relevant research, the prevalence of this disease in adults aged 20 is 0.1%-0.2%, while it is 0.5%-3.8% in minors. This disease easily leads to motor dysfunction and even loss of self-care ability. The lifetime incidence rate worldwide is as high as 85%, with a recurrence rate of 24%-33%. TCM classifies various lumbar diseases, such as lumbar muscle strain, lumbar spondylosis, lumbar disc herniation (LDH), lumbar fibrositis, osteoporosis, and ankylosing spondylitis (AS), under the category of lower back pain for diagnosis and treatment. Modern medicine has numerous related diseases and symptoms of lower back pain, but they are mostly related to deficiency, with kidney deficiency being a central theme in TCM diagnosis, often accompanied by other pathogenic factors. The "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine" classifies lower back pain into four types: cold-dampness lower back pain, damp-heat lower back pain, blood stasis lower back pain, and kidney deficiency lower back pain. In modern medicine, the TCM syndrome of lower back pain is closely related to kidney deficiency, and is associated with the liver, spleen, and kidneys. The pathogenesis presents a mixed pattern of deficiency and excess, with common syndrome types including liver and kidney deficiency, spleen and kidney yang deficiency, qi and blood deficiency, damp-heat obstruction, cold-damp obstruction, qi stagnation and blood stasis, or concurrent kidney and Du meridian deficiency, and phlegm and blood stasis. Among these, lower back pain due to kidney yin deficiency is the most common. Summary of the Invention

[0003] To further improve the efficacy of medicines for treating kidney yin deficiency and lower back pain, this application provides a blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain, and its preparation method, using the following technical solution.

[0004] A blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain is prepared from the following Chinese herbal medicines in parts by weight: 25-35 parts Rehmannia glutinosa, 20-30 parts Cornus officinalis, 18-22 parts Eucommia ulmoides, 15-25 parts Achyranthes bidentata, 20-30 parts Angelica sinensis, 22-30 parts Ligusticum chuanxiong, 20-28 parts Salvia miltiorrhiza, 15-25 parts Curcuma zedoaria, 20-30 parts Citrus reticulata peel, 10-20 parts Cyperus rotundus, 15-25 parts Bupleurum chinense, 20-30 parts Atractylodes macrocephala, 15-25 parts Citrus aurantium, 18-22 parts Amomum villosum, 20-30 parts Scutellaria baicalensis, 15-25 parts Morus alba root bark, 10-20 parts Prunus armeniaca, and 15-25 parts Eriobotrya japonica leaf.

[0005] The aforementioned blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain is prepared from the following Chinese medicinal herbs in parts by weight: 30 parts Rehmannia glutinosa, 25 parts Cornus officinalis, 20 parts Eucommia ulmoides, 20 parts Achyranthes bidentata, 25 parts Angelica sinensis, 27 parts Ligusticum chuanxiong, 24 parts Salvia miltiorrhiza, 20 parts Curcuma zedoaria, 25 parts Citrus reticulata peel, 15 parts Cyperus rotundus, 20 parts Bupleurum chinense, 25 parts Atractylodes macrocephala, 20 parts Citrus aurantium, 20 parts Amomum villosum, 25 parts Scutellaria baicalensis, 20 parts Morus alba root bark, 15 parts Prunus armeniaca, and 20 parts Eriobotrya japonica leaf.

[0006] The aforementioned blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain is prepared from the following Chinese medicinal herbs in parts by weight: 25 parts Rehmannia glutinosa, 30 parts Cornus officinalis, 18 parts Eucommia ulmoides, 25 parts Achyranthes bidentata, 20 parts Angelica sinensis, 30 parts Ligusticum chuanxiong, 20 parts Salvia miltiorrhiza, 25 parts Curcuma zedoaria, 20 parts Citrus reticulata peel, 20 parts Cyperus rotundus, 15 parts Bupleurum chinense, 30 parts Atractylodes macrocephala, 15 parts Citrus aurantium, 22 parts Amomum villosum, 20 parts Scutellaria baicalensis, 25 parts Morus alba root bark, 10 parts Prunus armeniaca, and 25 parts Eriobotrya japonica leaf.

[0007] The aforementioned blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain is prepared from the following Chinese medicinal herbs in parts by weight: 35 parts Rehmannia glutinosa, 20 parts Cornus officinalis, 22 parts Eucommia ulmoides, 15 parts Achyranthes bidentata, 30 parts Angelica sinensis, 22 parts Ligusticum chuanxiong, 28 parts Salvia miltiorrhiza, 15 parts Curcuma zedoaria, 30 parts Citrus reticulata peel, 10 parts Cyperus rotundus, 25 parts Bupleurum chinense, 20 parts Atractylodes macrocephala, 25 parts Citrus aurantium, 18 parts Amomum villosum, 30 parts Scutellaria baicalensis, 15 parts Morus alba root bark, 20 parts Prunus armeniaca, and 15 parts Eriobotrya japonica leaf.

[0008] The preparation method of the aforementioned blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain includes the following steps: Extracting the following Chinese medicinal herbs from the above-mentioned decoction pieces—Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca—with alcohol, and combining the alcohol extracts; decocting the residue with other Chinese medicinal herbs twice, adding 8-10 times the weight of the herbs in the first decoction and 6-8 times the weight in the second decoction, with each decoction lasting 1-3 hours; combining the decoctions and concentrating to a thick paste at 25°C. The concentration temperature was 30℃ to a relative density of 1.20-1.25, the concentration temperature was 60-70℃, the concentration vacuum degree was -(0.06-0.08)MPa, and the alcohol precipitation time was 24-36h. The supernatant was taken and combined with the aforementioned alcohol extracts of Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca. The mixture was then concentrated until there was basically no ethanol in the clear extract. The concentration temperature was 60-70℃ and the concentration vacuum degree was -(0.06-0.08)MPa.

[0009] In the preparation method of the aforementioned blood-nourishing and kidney-tonifying pill for treating kidney yin deficiency and lower back pain, the alcohol extraction is carried out by reflux extraction with 80-95% ethanol, and the alcohol extraction is carried out twice. The first extraction uses an alcohol solution with 5-7 times the weight of the Chinese herbal medicine raw material and the extraction time is 1-2 hours. The second extraction uses an alcohol solution with 3-5 times the weight of the Chinese herbal medicine raw material and the extraction time is 1-2 hours. The two alcohol extracts are combined.

[0010] For the Yangxue Bushen Pills for treating lumbago due to kidney yin deficiency, in the preparation method, the clear extract is concentrated to a thick extract at 25-30°C with a relative density of 1.30-1.35, the concentration vacuum degree is -(0.06-0.08) Mpa, the concentration temperature is 60-70°C, and refined honey is added to prepare pills.

[0011] Application of the Yangxue Bushen Pills for treating lumbago due to kidney yin deficiency in the preparation of drugs for treating lumbago due to kidney yin deficiency.

[0012] The lumbago is mainly characterized by soreness and weakness, being fond of pressing and kneading, weakness in the legs and knees, getting worse with exertion and alleviating when lying down, and often recurring. In those with yin deficiency, there will be restlessness and insomnia, dry mouth and throat, flushing of the face, heat in the palms and soles of the feet, red tongue, and thready, rapid and fine pulse. Pathogenesis analysis: The waist is the residence of the kidneys, and the kidneys govern the bone marrow. Deficiency of the kidney essence leads to insufficient bone marrow, resulting in soreness and weakness in the waist and weakness in the legs and knees. The disease belongs to the deficiency syndrome, so it is fond of pressing and kneading. Exertion consumes qi, so it gets worse with exertion and alleviates when lying down. Yin deficiency leads to insufficient body fluids, and the upward flaring of deficient fire causes restlessness and insomnia, dry mouth and throat, heat in the palms and soles of the feet, red tongue, and thready, rapid and fine pulse, which are signs of yin deficiency with heat. Patients with kidney yin deficiency have insufficient qi and blood, which are caused by insufficient body fluids and exuberant deficient fire. When there is kidney yin deficiency, the kidney yin fluid is deficient and cannot nourish various parts of the body, leading to failure of yin to control yang, internal disturbance of deficient fire, and further consumption of yin blood, resulting in a decrease in blood production and thus triggering the situation of insufficient qi and blood. Therefore, nourishing blood is needed.

[0013] Lumbago belongs to the categories of "Bi syndrome" and "Pain syndrome" in traditional Chinese medicine. "Plain Questions · Pulse Manifestation and Fine Subtleties Theory" states: "The waist is the residence of the kidneys. If it cannot turn and move, the kidneys will be debilitated", first pointing out the close relationship between lumbar diseases and the kidneys. "General Treatise on the Causes and Symptoms of Various Diseases · Syndromes of Low Back and Back Diseases" believes that lumbago is related to factors such as deficiency of kidney qi, invasion of wind, cold and damp pathogens, long-term fatigue injuring the kidneys, falling and injuring the waist, and sleeping on damp ground. "Danxi's Methods of Treatment · Lumbago" records: "Lumbago is mainly due to damp-heat, kidney deficiency, blood stasis, sprain and contusion, and phlegm accumulation." "Seven Pine Cliff Collection · Lumbago" summarizes the common causes and deficiency and excess of lumbago, that is, "However, pain has the distinction of deficiency and excess. The so-called deficiency means the deficiency of the essence, qi, blood and spirit of the two kidneys. All cases of deficiency syndromes are diseases of the two kidneys themselves. The so-called excess does not mean self-excess of the kidneys, but that in the channels and collaterals and blood vessels of the two waists, they are invaded by wind, cold and damp, obstructed by sprain and contusion qi, and the cavity inside the waist is stagnated by damp phlegm and blood stasis, and the obstruction causes pain. It should be differentiated according to the pulse and symptoms." Lumbago due to kidney yin deficiency is one of the lumbagos and also the most common one. The main treatment principle for those with lumbago due to kidney yin deficiency is to nourish the kidney and benefit yin.

[0014] "Plain Questions · Treatise on Acupuncture for Lumbago": "The Hengluo meridian causes lumbago, making it impossible to bend forward or backward. When bending backward, there is fear of falling. It is caused by lifting heavy objects and injuring the waist. The Hengluo meridian is severed, and evil blood returns to it. Needle at the space between the Yangjin tendons, several inches above, and make two punctures at the location of the Hengluo to let out blood." When blood stasis blocks the lumbar meridian and qi and blood circulation is不畅, promoting blood circulation to remove blood stasis is also needed.

[0015] Yang Shiying's *Ren Zhai Zhi Zhi Fang* (Direct Guide to Prescriptions from Ren Zhai) states in its section on "Lower Back Pain": "Kidney deficiency is the root cause of lower back pain. When kidney qi is deficient, various forms of lower back pain arise, including exposure to wind, dampness, cold, heat accumulation, blood stasis, qi stagnation, water retention, falls, loss of will, and overexertion." Yang further states, "The liver governs the tendons and is connected to the kidneys," and the spleen nourishes the five viscera, serving as "the storehouse of the kidneys… Anger injures the liver, causing the tendons to become lax; worry injures the spleen, causing the stomach qi to stagnate; both can cause lower back pain." Therefore, methods to soothe the liver and strengthen the spleen can be used to treat lower back pain caused by kidney yin deficiency.

[0016] In addition, the lungs generate the kidneys, just as metal generates water. For example, the essence of the lungs flows downward to nourish the essence of the kidneys, and the lung qi descends to help the kidneys receive qi. By clearing the lungs, one can also achieve the purpose of tonifying the kidneys.

[0017] In summary, this invention uses Rehmannia glutinosa and Cornus officinalis to nourish blood and replenish kidney yin, and Eucommia ulmoides and Achyranthes bidentata to strengthen the waist and knees, as the principal herbs; Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, and Curcuma zedoaria to invigorate blood and remove blood stasis, as the assistant herbs; Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, Atractylodes macrocephala, Citrus aurantium, and Amomum villosum to soothe the liver and strengthen the spleen, as the adjuvant herbs; and Scutellaria baicalensis, Morus alba root bark, Prunus armeniaca seed, and Eriobotrya japonica leaf to clear the lungs and promote downward movement, as the guiding herbs. The entire formula contains Rehmannia glutinosa, Cornus officinalis, Eucommia ulmoides, Achyranthes bidentata, Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, Atractylodes macrocephala, Citrus aurantium, Amomum villosum, Scutellaria baicalensis, Morus alba root bark, Prunus armeniaca seed, and Eriobotrya japonica leaf, which treat kidney yin deficiency and lower back pain by nourishing blood and replenishing kidney yin. Detailed Implementation

[0018] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, but these equivalent forms also fall within the scope defined by the appended claims.

[0019] Example 1: Take 30g of Rehmannia glutinosa, 25g of Cornus officinalis, 20g of Eucommia ulmoides, 20g of Achyranthes bidentata, 25g of Angelica sinensis, 27g of Ligusticum chuanxiong, 24g of Salvia miltiorrhiza, 20g of Curcuma zedoaria, 25g of Citrus reticulata peel, 15g of Cyperus rotundus, 20g of Bupleurum chinense, 25g of Atractylodes macrocephala, 20g of Citrus aurantium, 20g of Amomum villosum, 25g of Scutellaria baicalensis, 20g of Morus alba root bark, 15g of Prunus armeniaca, and 20g of Eriobotrya japonica leaf. The preparation method includes the following steps: Take Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca from the above-mentioned Chinese medicinal materials for alcohol extraction. The alcohol extraction is carried out by reflux extraction with 90% ethanol. The alcohol extraction is carried out twice. The first time, an alcohol solution with 6 times the weight of the Chinese medicinal materials is used for extraction for 2 hours. The second time, an alcohol solution with 4 times the weight of the Chinese medicinal materials is used for extraction for 1 hour. Combine the two alcohol extracts. After alcohol extraction, the residue was decocted twice with other Chinese medicinal herbs. The first decoction used nine times the weight of the herbs, and the second used seven times the weight. Each decoction lasted 2 hours. The decoctions were combined and concentrated to a thick paste at 28°C with a relative density of 1.22. The concentration temperature was 65°C, and the concentration vacuum was -0.07 MPa. The mixture was allowed to stand for 32 hours for alcohol precipitation. The supernatant was then combined with the aforementioned alcohol extracts of Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca. The mixture was then concentrated again until the clear paste contained virtually no ethanol. The further concentration temperature was 65°C, and the concentration vacuum was -0.07 MPa. The clear paste was then concentrated to a thick paste at 28°C with a relative density of 1.32, a concentration vacuum of -0.07 MPa, and a concentration temperature of 65°C. Refined honey was added to prepare pills.

[0020] Example 2:

[0021] Take 25g of Rehmannia glutinosa (processed), 30g of Cornus officinalis, 18g of Eucommia ulmoides, 25g of Achyranthes bidentata, 20g of Angelica sinensis, 30g of Ligusticum chuanxiong, 20g of Salvia miltiorrhiza, 25g of Curcuma zedoaria, 20g of Citrus reticulata peel, 20g of Cyperus rotundus, 15g of Bupleurum chinense, 30g of Atractylodes macrocephala, 15g of Citrus aurantium, 22g of Amomum villosum, 20g of Scutellaria baicalensis, 25g of Morus alba root bark, 10g of Prunus armeniaca seed, and 25g of Eriobotrya japonica leaf. The preparation method includes the following steps: Take Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca seed from the above-mentioned Chinese medicinal herbs for alcohol extraction. The alcohol extraction is performed by reflux extraction with 80% ethanol, and the extraction is performed twice. The first extraction uses an alcohol solution with 7 times the weight of the raw Chinese medicinal herbs for 1 hour, and the second extraction uses an alcohol solution with 5 times the weight of the raw Chinese medicinal herbs for 2 hours. Combine the two alcohol extracts; after alcohol extraction... The dregs were decocted twice with other Chinese medicinal herbs. The first decoction used eight times the weight of the herbs, and the second decoction used eight times the weight of the herbs. Each decoction was for 1 hour. The decoctions were combined and concentrated to a thick paste at 30°C until the relative density was 1.20. The concentration temperature was 70°C, and the concentration vacuum was -0.06 MPa. The mixture was allowed to stand for 36 hours for alcohol precipitation. The supernatant was then combined with the aforementioned alcohol extracts of Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca. This mixture was then concentrated again until the clear paste contained virtually no ethanol. The concentration temperature was 70°C, and the concentration vacuum was -0.06 MPa. The clear paste was then concentrated to a thick paste at 30°C until the relative density was 1.30, and the concentration vacuum was -0.08 MPa. The concentration temperature was 60°C. Honey was added to prepare pills.

[0022] Example 3:

[0023] Take 35g of Rehmannia glutinosa (processed), 20g of Cornus officinalis, 22g of Eucommia ulmoides, 15g of Achyranthes bidentata, 30g of Angelica sinensis, 22g of Ligusticum chuanxiong, 28g of Salvia miltiorrhiza, 15g of Curcuma zedoaria, 30g of Citrus reticulata peel, 10g of Cyperus rotundus, 25g of Bupleurum chinense, 20g of Atractylodes macrocephala, 25g of Citrus aurantium, 18g of Amomum villosum, 30g of Scutellaria baicalensis, 15g of Morus alba root bark, 20g of Prunus armeniaca seed, and 15g of Eriobotrya japonica leaf. The preparation method includes the following steps: Take Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca seed from the above-mentioned Chinese medicinal materials for alcohol extraction. The alcohol extraction is carried out by reflux extraction with 95% ethanol, and the alcohol extraction is carried out twice. The first extraction uses an alcohol solution with 5 times the weight of the Chinese medicinal materials and the extraction time is 2 hours. The second extraction uses an alcohol solution with 3 times the weight of the Chinese medicinal materials and the extraction time is 2 hours. Combine the extracts. Two alcohol extracts were prepared. After alcohol extraction, the residue was decocted twice with other Chinese medicinal herbs. The first decoction was 8 times the weight of the Chinese medicinal herbs, and the second decoction was 8 times the weight of the Chinese medicinal herbs. Each decoction was 1 hour long. The decoctions were combined and concentrated to a thick paste at 30°C until the relative density was 1.20. The concentration temperature was 70°C and the concentration vacuum was -0.08 MPa. The alcohol precipitation time was 24 hours. The supernatant was collected and combined with the aforementioned alcohol extracts of Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca. The mixture was then concentrated again until the clear paste contained almost no ethanol. The concentration temperature was 70°C and the concentration vacuum was -0.06 MPa. The clear paste was concentrated to a thick paste at 25°C until the relative density was 1.35. The concentration vacuum was -0.06 MPa and the concentration temperature was 70°C. Honey was added to prepare pills.

[0024] Example 4: Clinical Study

[0025] Eighty patients diagnosed with kidney yin deficiency and lower back pain at the outpatient clinic of Nanjing Pukou District Traditional Chinese Medicine Hospital between February 2022 and February 2023 were selected and randomly divided into a control group (n=40) and a study group (n=40). The control group was aged 35-50 years with a disease duration of 2-12 months, while the study group was aged 34-52 years with a disease duration of 2-11 months. There were no statistically significant differences in age and disease duration between the two groups (P>0.05), indicating comparability.

[0026] Diagnostic criteria: Western medicine diagnostic criteria refer to the "Practical Orthopedics, Third Edition" (1) Low back pain combined with radiating pain in the lower limbs, which worsens with increased abdominal pressure; (2) Significant tenderness in the paravertebral segment of the affected area, radiating to the lower limbs, with lumbar movement disorders or passive posture; (3) Sensory disturbances in the area innervated by the affected nerve, lower limb muscle atrophy, muscle weakness, weakened or absent tendon reflexes; (4) Positive straight leg raise test and reinforced test; (5) CT and MRI showing lumbar intervertebral disc herniation. Traditional Chinese medicine syndrome differentiation diagnostic criteria refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs". Low back pain is mainly characterized by soreness and weakness, which is relieved by pressure and rubbing, weakness in the legs and knees, which is aggravated by exertion and relieved by lying down. It often recurs, accompanied by irritability, insomnia, dry mouth and throat, flushed face, hot palms and soles, red tongue, and wiry, thready and rapid pulse.

[0027] Inclusion criteria: (1) Possess basic communication and comprehension skills; (2) Have no other diseases currently under treatment; (3) Voluntarily participate in this study and sign an informed consent form. Exclusion criteria: (1) Have a history of mental illness and be unable to complete this study; (2) Have other serious diseases or other diseases requiring treatment; (3) Have poor adherence, fail to take medication as prescribed, or add other therapeutic drugs on their own, thereby affecting the determination of the effect.

[0028] Treatment methods: The control group was given Zhuangyao Jianshen Wan (National Medicine Approval Number Z44021150, Guangdong Hongxing Group Co., Ltd. Hongxing Pharmaceutical Factory, Batch No.: 20210302), 10g three times a day each time; the group in Example 1 used the pills prepared by the method in Example 1, with the following daily prescription: 30g Rehmannia glutinosa, 25g Cornus officinalis, 20g Eucommia ulmoides, 20g Achyranthes bidentata, 25g Angelica sinensis, 27g Ligusticum chuanxiong, 24g Salvia miltiorrhiza, 20g Curcuma zedoaria, 25g Citrus reticulata peel, 15g Cyperus rotundus, 20g Bupleurum chinense, 25g Atractylodes macrocephala, 20g Citrus aurantium, 20g Amomum villosum, 25g Scutellaria baicalensis, 20g Morus alba root bark, 15g Prunus armeniaca, and 20g Eriobotrya japonica leaf, taken in 3 divided doses, 2 weeks as one course of treatment, for a total of 2 courses.

[0029] Observation indicators: (1) Pain indicators: The visual analog scale (VAS) was used for evaluation, and the score was 0-10 according to the degree of pain. The higher the score, the more severe the pain symptoms. (2) Activity function indicators: The Oswestry Disability Index (ODI) and the Japanese Orthopaedic Association (JOA) score were used respectively. The ODI score includes 10 items such as lifting objects, walking, standing for long periods of time, and sexual activity. Each item is scored from 0 to 5 points, and the total score is 50 points. The higher the score, the more severe the functional impairment. The JOA was used to evaluate lumbar spine function, and the score was 0-29 points. The higher the score, the better the lumbar spine function. (3) Traditional Chinese medicine symptom scores: The scores of TCM clinical symptoms and signs before and after treatment were compared. Each item was scored from 0 to 6 points. The higher the score, the more severe the condition. (4) Efficacy: Refer to the efficacy evaluation criteria in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines": Cured: The patient's symptoms and signs completely disappeared, and the activity function returned to normal; Significantly effective: The patient's pain, activity function, TCM symptoms and other scores decreased by ≥70% or more compared with the previous scores; Effective: 30% ≤ The patient's pain, activity function, TCM symptoms and other scores decreased by ≥30% and <70% compared with the previous scores; Ineffective: The patient's pain, activity function, TCM symptoms and other scores decreased by <30% compared with the previous scores, or there was no change or even aggravation compared with the previous scores. Total effective rate = (number of cured + number of significantly effective + number of effective cases) / total number of cases × 100%.

[0030] Comparison of efficacy between the two groups of patients: After 4 weeks of treatment, in the Example 1 group of the present invention, 12 cases were cured, 18 cases showed significant improvement, 8 cases showed improvement, and 2 cases were ineffective, with a total effective rate of 95.0% (38 / 40). In the control group, 5 cases were cured, 14 cases showed significant improvement, 12 cases showed improvement, and 9 cases were ineffective, with a total effective rate of 77.5% (31 / 40). The Example 1 group of the present invention was higher than that of the control group, and the difference was statistically significant (P<0.05), indicating that the present invention has a significant effect on treating kidney yin deficiency and lower back pain.

[0031] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A blood-nourishing kidney-tonifying pill for treating kidney-yin deficiency-induced lumbago, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in parts by weight: 25-35 parts of Rehmannia glutinosa, 20-30 parts of Cornus officinalis, 18-22 parts of Eucommia ulmoides, 15-25 parts of Achyranthes bidentata, 20-30 parts of Angelica sinensis, 22-30 parts of Ligusticum chuanxiong, 20-28 parts of Salvia miltiorrhiza, 15-25 parts of Curcuma zedoaria, 20-30 parts of Citrus reticulata peel, 10-20 parts of Cyperus rotundus, 15-25 parts of Bupleurum chinense, 20-30 parts of Atractylodes macrocephala, 15-25 parts of Citrus aurantium, 18-22 parts of Amomum villosum, 20-30 parts of Scutellaria baicalensis, 15-25 parts of Morus alba root bark, 10-20 parts of Prunus armeniaca, and 15-25 parts of Eriobotrya japonica leaf.

2. The blood-nourishing kidney-tonifying pill for treating kidney-yin deficiency-induced lumbago according to claim 1, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in parts by weight: 30 parts Rehmannia glutinosa, 25 parts Cornus officinalis, 20 parts Eucommia ulmoides, 20 parts Achyranthes bidentata, 25 parts Angelica sinensis, 27 parts Ligusticum chuanxiong, 24 parts Salvia miltiorrhiza, 20 parts Curcuma zedoaria, 25 parts Citrus reticulata peel, 15 parts Cyperus rotundus, 20 parts Bupleurum chinense, 25 parts Atractylodes macrocephala, 20 parts Citrus aurantium, 20 parts Amomum villosum, 25 parts Scutellaria baicalensis, 20 parts Morus alba root bark, 15 parts Prunus armeniaca, and 20 parts Eriobotrya japonica leaf.

3. The blood-nourishing kidney-tonifying pill for treating kidney-yin deficiency-induced lumbago according to Claim 1, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in parts by weight: 25 parts Rehmannia glutinosa, 30 parts Cornus officinalis, 18 parts Eucommia ulmoides, 25 parts Achyranthes bidentata, 20 parts Angelica sinensis, 30 parts Ligusticum chuanxiong, 20 parts Salvia miltiorrhiza, 25 parts Curcuma zedoaria, 20 parts Citrus reticulata peel, 20 parts Cyperus rotundus, 15 parts Bupleurum chinense, 30 parts Atractylodes macrocephala, 15 parts Citrus aurantium, 22 parts Amomum villosum, 20 parts Scutellaria baicalensis, 25 parts Morus alba root bark, 10 parts Prunus armeniaca, and 25 parts Eriobotrya japonica leaf.

4. The blood-nourishing kidney-tonifying pill for treating kidney-yin deficiency-induced lumbago according to Claim 1, characterized in that, It is prepared by extracting the following Chinese medicinal herbs in parts by weight: 35 parts Rehmannia glutinosa, 20 parts Cornus officinalis, 22 parts Eucommia ulmoides, 15 parts Achyranthes bidentata, 30 parts Angelica sinensis, 22 parts Ligusticum chuanxiong, 28 parts Salvia miltiorrhiza, 15 parts Curcuma zedoaria, 30 parts Citrus reticulata peel, 10 parts Cyperus rotundus, 25 parts Bupleurum chinense, 20 parts Atractylodes macrocephala, 25 parts Citrus aurantium, 18 parts Amomum villosum, 30 parts Scutellaria baicalensis, 15 parts Morus alba root bark, 20 parts Prunus armeniaca, and 15 parts Eriobotrya japonica leaf.

5. The blood-nourishing and kidney-tonifying pill for treating lower back pain due to kidney yin deficiency as described in claim 1, characterized in that, The preparation method includes the following steps: Take the following Chinese medicinal herbs from the above-mentioned decoction pieces: Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca, and extract with alcohol. Combine the alcohol extracts. After alcohol extraction, decoct the residue with other Chinese medicinal herbs twice. For the first decoction, add 8-10 times the weight of the Chinese medicinal herbs; for the second decoction, add 6-8 times the weight of the Chinese medicinal herbs. Each decoction and water extraction takes 1-3 hours. Combine the decoctions and concentrate to a thick paste at 25-30℃ until the relative density is reached. The concentration temperature was 60-70℃, the concentration vacuum was -(0.06-0.08)MPa, and the alcohol precipitation time was 24-36h. The supernatant was taken and combined with the aforementioned alcohol extracts of Angelica sinensis, Ligusticum chuanxiong, Salvia miltiorrhiza, Curcuma zedoaria, Citrus reticulata peel, Cyperus rotundus, Bupleurum chinense, and Prunus armeniaca. The mixture was then concentrated until no ethanol was found in the clear extract. The concentration temperature was 60-70℃ and the concentration vacuum was -(0.06-0.08)MPa.

6. The blood-nourishing and kidney-tonifying pill for treating lower back pain due to kidney yin deficiency as described in claim 5, characterized in that, In the preparation method, the alcohol extraction is carried out by reflux extraction with 80-95% ethanol. The alcohol extraction is carried out twice. The first extraction uses an alcohol solution with 5-7 times the weight of the Chinese herbal medicine raw material and the extraction time is 1-2 hours. The second extraction uses an alcohol solution with 3-5 times the weight of the Chinese herbal medicine raw material and the extraction time is 1-2 hours. The two alcohol extracts are combined.

7. The blood-nourishing and kidney-tonifying pill for treating lower back pain due to kidney yin deficiency as described in claim 5, characterized in that, In the preparation method, the clear paste is concentrated to a thick paste at 25-30℃ with a relative density of 1.30-1.35, a concentration vacuum degree of -(0.06-0.08) MPa, a concentration temperature of 60-70℃, and refined honey is added to prepare pills.