A traditional Chinese medicine composition, a traditional Chinese medicine mixture for treating bone and orthopedic diseases caused by liver and kidney deficiency and a preparation method thereof

Abstract

A traditional Chinese medicine composition and mixture for treating bone trauma caused by liver and kidney deficiency and a preparation method thereof belong to the technical field of traditional Chinese medicines. The composition is prepared by mixing Epimedium, Dipsacus, Rubus, Radix Rehmanniae Preparata, Morinda, Eucommia, turtle shell in vinegar, calcined oyster and sodium benzoate in specific weight ranges. The composition has a clear structure of monarch, minister and assistant, and can supplement yin and yang. The composition has strong targeting for bone trauma caused by liver and kidney deficiency, such as lumbar pain, lower limb atrophy, difficulty in walking, dizziness and tinnitus, brittle bones, easy to break, lumbar disc herniation and osteoporosis. The composition has definite clinical effects. The preparation method sets scientific and reasonable parameter ranges for extraction, concentration and preparation processes, which can ensure sufficient dissolution and stable transfer of effective components such as icariin, avoid damage of heat-sensitive components, and make the quality of different batches of products uniform and controllable. The preparation method is suitable for conventional equipment, easy for industrialized production, and has good clinical application value and social benefits.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition, a traditional Chinese medicine compound, and a method for preparing the same for treating bone and joint injuries caused by liver and kidney deficiency. Background Technology

[0002] Liver and kidney deficiency is one of the core TCM syndrome patterns in orthopedic diseases. In TCM theory, "the liver governs the tendons and the kidneys govern the bones." Deficiency of the liver and kidneys leads to malnourishment of the tendons and bones, clinically manifesting as symptoms such as lower back pain, lower limb atrophy, difficulty walking, dizziness, tinnitus, and brittle bones. This syndrome pattern is widely present in common orthopedic diseases such as lumbar disc herniation, osteoporosis, and degenerative osteoarthritis, and is both a key focus and a challenge in clinical diagnosis and treatment.

[0003] For orthopedic conditions caused by liver and kidney deficiency, traditional Chinese medicine has historically followed the treatment principle of "tonifying the liver and kidneys, strengthening tendons and bones," commonly using formulas composed of kidney-tonifying and bone-strengthening herbs such as Epimedium, Dipsacus, Drynaria, Rehmannia, and Eucommia. Currently, clinically available treatments mainly include traditional Chinese herbal decoctions and some prepared Chinese medicines (such as pills, capsules, and granules). However, existing preparations still have several significant shortcomings in actual clinical application and production: (1) Insufficient targeted formulation: Most existing preparations are general-purpose orthopedic drugs. The formulation design often takes into account multiple effects such as dispelling wind and dampness, promoting blood circulation and removing blood stasis. The targeted combination for the core pathogenesis of "liver and kidney deficiency" is insufficient, and the dosage structure of the principal, assistant, adjuvant and guide is not clear enough, resulting in poor accuracy and consistency of clinical efficacy.

[0004] (2) Low standardization of production process: Traditional decoctions rely entirely on manual decoction by clinicians. There are no standardized quantitative parameters for water volume, soaking time, decoction time, and heat control. The dissolution rate of effective ingredients varies greatly between different operators and different batches. Even for some traditional Chinese medicines that have achieved industrialized production, the parameter windows for key processes such as extraction and concentration are often set too wide and there is a lack of precise process control nodes, resulting in poor quality stability of different batches of products and significant fluctuations in the content of effective ingredients.

[0005] (3) Inadequate quality control system: The quality control of existing preparations is mostly limited to basic physical indicators such as appearance observation and relative density determination. There is a lack of quantitative detection of characteristic active ingredients (such as icariin), and a full-process, multi-point quality monitoring system has not been established from raw material weighing, extraction and decoction, concentration and density, preparation and filtration to filling and filling. It is difficult to effectively ensure the uniformity and safety of the finished product.

[0006] (4) There is a contradiction between dosage form selection and ease of administration: Traditional decoctions require patients to prepare them themselves or medical institutions to prepare and use them immediately, which is time-consuming and labor-intensive, has a short shelf life, and results in poor patient compliance. Most existing traditional Chinese medicines are in the form of solid dosage forms such as pills and capsules, which are convenient to carry, but have limited disintegration and dissolution rates, making it difficult to meet the clinical needs of patients in the acute phase of orthopedic trauma. Granules need to be dissolved in hot water and often contain a large amount of excipients (such as sucrose), which limits their use and is not suitable for special populations such as diabetics.

[0007] (5) The synergistic effect of specific dosage ratio and process parameters has not been fully explored: Even though some compound preparations containing similar medicinal materials such as Epimedium, Rehmannia glutinosa, Eucommia ulmoides, and Dipsacus asper have been disclosed in the existing technology, the weight ratio between each medicinal material has not been systematically optimized, and there are very few technical solutions that combine specific ratios with parameterized water extraction, vacuum concentration, and step-by-step preparation processes to form a standardized production process, which makes it difficult to balance the efficacy stability and industrial reproducibility of the product.

[0008] In summary, there is an urgent need in this field to develop a traditional Chinese medicine composition and its preparation method that features a scientifically precise formulation, optimized weight ratios, standardized process parameters, controllable quality throughout the process, and rapid absorption and convenient administration in a compound dosage form, so as to better meet the clinical needs for treating orthopedic diseases caused by liver and kidney deficiency. Summary of the Invention

[0009] The purpose of this invention is to provide a traditional Chinese medicine composition, a traditional Chinese medicine compound, and its preparation method for treating orthopedic diseases caused by liver and kidney deficiency. The formula is scientifically and rationally combined, and has the effects of softening blood vessels and regulating the three highs (high blood pressure, high blood sugar, and high cholesterol). It has a better therapeutic effect on orthopedic diseases caused by liver and kidney deficiency.

[0010] The embodiments of the present invention are implemented as follows: A traditional Chinese medicine composition for treating bone and joint injuries caused by liver and kidney deficiency, comprising, by weight, the following raw materials: Epimedium 80-100 parts, Dipsacus asper 80-100 parts, Drynaria fortunei 70-85 parts, Rehmannia glutinosa 110-125 parts, Morinda officinalis 70-85 parts, Eucommia ulmoides 70-85 parts, vinegar-processed tortoise shell 80-100 parts, calcined oyster shell 80-100 parts, and sodium benzoate 7-9 parts.

[0011] A traditional Chinese medicine compound for treating bone and joint injuries caused by liver and kidney deficiency is prepared by mixing the above-mentioned traditional Chinese medicine composition with water.

[0012] A method for preparing the above-mentioned traditional Chinese medicine compound, comprising: S1. Mix Epimedium, Dipsacus asper, Drynaria fortunei, Rehmannia glutinosa, Morinda officinalis, Eucommia ulmoides, vinegar-processed tortoise shell, and calcined oyster shell to obtain a mixture; S2. Mix the mixture with water, extract, and decoct to obtain a decoction; S3. Concentrate the decoction to a relative density of 1.02~1.08 (80℃±2℃) to obtain a concentrated solution; S4. Mix the concentrated solution and sodium benzoate, and add the remaining water to prepare a traditional Chinese medicine compound.

[0013] The beneficial effects of the embodiments of the present invention are: This invention provides a traditional Chinese medicine composition, a compound preparation, and its preparation method for treating orthopedic conditions caused by liver and kidney deficiency. The composition comprises Epimedium, Dipsacus, Drynaria, Rehmannia glutinosa, Morinda officinalis, Eucommia ulmoides, vinegar-processed tortoise shell, calcined oyster shell, and sodium benzoate in specific weight proportions. The composition has a clear principal-assistant-adjuvant structure, tonifying both Yin and Yang. It is highly targeted at orthopedic conditions caused by liver and kidney deficiency, such as lower back pain, lower limb atrophy, difficulty walking, dizziness, tinnitus, brittle bones, lumbar disc herniation, and osteoporosis, demonstrating definite clinical efficacy. The preparation method sets scientifically reasonable parameter ranges for extraction, concentration, and formulation processes. It employs a two-step decoction combined with vacuum low-temperature concentration and step-by-step water addition, ensuring the full dissolution and stable transfer of effective components such as icariin while avoiding damage to heat-sensitive components, thus ensuring consistent and controllable quality across different batches. The final herbal compound requires no disintegration, is rapidly absorbed orally, has a quick onset of action, is convenient to carry, provides accurate dosage, and enjoys high patient compliance. The product also specifies quantitative indicators such as relative density, pH value, and icariin content, further ensuring quality control and safety. The combination of this specific formulation and parameterized process produces an unexpected synergistic effect, which is not readily apparent. Furthermore, the process is compatible with conventional equipment, facilitating large-scale industrial production, and possesses significant clinical application value and social benefits. Detailed Implementation

[0014] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0015] The following is a detailed description of a traditional Chinese medicine composition, a traditional Chinese medicine compound, and its preparation method for treating orthopedic diseases caused by liver and kidney deficiency, according to an embodiment of the present invention.

[0016] This invention provides a traditional Chinese medicine composition for treating bone and joint injuries caused by liver and kidney deficiency. The raw materials, by weight, include: Epimedium 80-100 parts, Dipsacus asper 80-100 parts, Drynaria fortunei 70-85 parts, Rehmannia glutinosa 110-125 parts, Morinda officinalis 70-85 parts, Eucommia ulmoides 70-85 parts, vinegar-processed tortoise shell 80-100 parts, calcined oyster shell 80-100 parts, and sodium benzoate 7-9 parts.

[0017] Furthermore, the raw materials, by weight, include: Epimedium 85-95 parts, Dipsacus asper 85-95 parts, Drynaria fortunei 75-82 parts, Rehmannia glutinosa 115-122 parts, Morinda officinalis 75-82 parts, Eucommia ulmoides 75-82 parts, Vinegar-processed tortoise shell 85-95 parts, Calcined oyster shell 85-95 parts, Sodium benzoate 7.5-8.5 parts.

[0018] Epimedium, with its pungent and sweet taste and warm nature, enters the liver and kidney meridians. Its functions include tonifying the kidneys and strengthening yang, strengthening tendons and bones, and dispelling wind and dampness. It is commonly used for symptoms such as kidney yang deficiency, weakness of tendons and bones, and cold pain in the lower back and knees. It can be used in combination with Morinda officinalis and Eucommia ulmoides. Modern research on compatibility studies shows that icariin in Epimedium has the effect of regulating estrogen levels and delaying bone loss, making it one of the core drugs for treating osteoporosis and other age-related diseases.

[0019] Rehmannia glutinosa is an essential medicine for nourishing yin and replenishing blood. It improves the state of bone malnutrition by nourishing kidney yin, and its components such as catalpol can increase bone density, making it especially suitable for postmenopausal osteoporosis.

[0020] Eucommia ulmoides, sweet in taste and warm in nature, enters the liver and kidney meridians. Its functions include tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus. It is primarily used to treat lower back and knee pain, and weakness of tendons and bones. The *Compendium of Materia Medica* states that it "moistens liver dryness and tonifies liver deficiency," and that "the liver governs tendons, and the kidneys govern bones; when the kidneys are strong, the bones are strong; when the liver is strong, the tendons are healthy." It contains eucommia gum, genipin, and other bone-forming substances. The eucommia gum it contains can also promote chondrocyte proliferation and has an improving effect on alleviating intervertebral disc degeneration.

[0021] Dipsacus asperoides, bitter and pungent in taste, slightly warm in nature, and enters the liver and kidney meridians. Its functions include tonifying the liver and kidneys, strengthening tendons and bones, healing fractures, and stopping metrorrhagia and uterine bleeding. It is an essential medicine for traumatology, "not only tonifying the liver and kidneys, but also promoting blood circulation, removing blood stasis, and healing tendons and injuries." The *Ben Cao Qiu Zhen* states that "Dipsacus asperoides is truly the foremost medicine for clearing qi and blood, tendons and bones." Its saponins can stimulate callus formation, making it suitable for osteoporosis combined with bone fractures.

[0022] Drynaria fortunei, bitter in taste and warm in nature, enters the liver and kidney meridians. Its functions include promoting blood circulation and healing injuries, tonifying the kidneys and strengthening bones. It can improve lower back and knee pain caused by osteoporosis and slow fracture healing, and also improve calcification of the intervertebral disc cartilage endplate.

[0023] Morinda officinalis, sweet and pungent in taste, slightly warm in nature, enters the kidney and liver meridians. It tonifies the kidney and strengthens yang, strengthens tendons and bones, dispels wind and dampness, and plays an "assistant" role in treating concurrent symptoms of liver and kidney deficiency (such as rheumatic pain and weakness of the lower limbs), assisting the principal and assistant herbs in enhancing their therapeutic effects.

[0024] Vinegar-processed tortoise shell nourishes yin and subdues yang, benefits the kidneys and strengthens bones, and nourishes blood and replenishes the heart. Its nature is predominantly yin, and in this formula it plays a "restraining" role—restraining the drying properties of warming yang herbs such as Epimedium and Morinda officinalis. This embodies the principle of "seeking yin within yang" in the formulation, preventing excessive warming and tonification from depleting yin fluids. This aligns with the principle of mutual restraint in the "New Compilation of Materia Medica," which states that "when Eucommia ulmoides and Rehmannia glutinosa are used together, the dryness and dampness are balanced, naturally eliminating the worry of excessive heat."

[0025] Calcined oyster shell has the functions of calming the liver and suppressing yang, astringing and consolidating, and softening and dispersing nodules. In the formula, it not only assists tortoise shell in nourishing yin and suppressing yang, but also uses its astringent properties to protect kidney qi, thus playing a targeted therapeutic role in "brittle bones, dizziness and tinnitus" caused by liver and kidney deficiency.

[0026] In this formula, Epimedium and Rehmannia glutinosa are the principal herbs, targeting the core pathogenesis of "liver and kidney deficiency." Epimedium warms and tonifies kidney yang and strengthens tendons and bones, directly addressing the main symptoms of "kidney yang deficiency and weakness of tendons and bones." Rehmannia glutinosa nourishes kidney yin and replenishes essence and marrow, directly addressing the main symptoms of "liver and kidney yin deficiency and malnourishment of bones." The two herbs combined form a dual-principal structure of "seeking yang within yin and yin within yang." In terms of dosage, Rehmannia glutinosa (110-125 parts) is the largest in the entire formula, conforming to the principle of "largest dosage" of the principal herb, followed by Epimedium (80-100 parts), together establishing the main axis of the formula of "tonifying the liver and kidneys."

[0027] Eucommia ulmoides, Dipsacus asper, and Drynaria fortunei are the three assistant herbs, used to assist the principal herb in strengthening the treatment of the main disease or symptoms. Eucommia ulmoides tonifies the liver and kidneys and strengthens tendons and bones, working synergistically with Epimedium and Rehmannia glutinosa to enhance the "strengthening tendons and bones" effect; Dipsacus asper tonifies the liver and kidneys, strengthens tendons and bones, and promotes healing of fractures, providing targeted treatment for the main symptoms of orthopedic injuries such as "fractures and bone fractures"; Drynaria fortunei invigorates blood circulation, promotes healing of injuries, tonifies the kidneys and strengthens bones, working in conjunction with Dipsacus asper to specifically target "fractures and delayed healing of bone fractures". The dosage of each of the three herbs is in the range of 70-85 parts, forming a reasonable "one principal herb, three assistant herbs" structure with the principal herb, and their potency is less than that of the principal herb.

[0028] Morinda officinalis, vinegar-processed tortoise shell, and calcined oyster shell are used as adjuvant herbs to assist the principal and assistant herbs in treating concurrent symptoms and to restrain their potent effects. Morinda officinalis acts as an adjuvant, assisting the principal and assistant herbs in treating secondary concurrent symptoms such as "rheumatic pain and weakness of the lower limbs." Vinegar-processed tortoise shell acts as an adjuvant, using its yin nature to restrain the warming and drying properties of Epimedium and Morinda officinalis, preventing the depletion of yin through excessive warming. Calcined oyster shell serves both as an adjuvant and a restraining agent, both assisting tortoise shell in suppressing yang and astringing and consolidating to protect kidney qi. The dosage of the three herbs is between 70 and 100 parts, with vinegar-processed tortoise shell and calcined oyster shell each at 80 to 100 parts, forming a group of adjuvant herbs that "both tonify yin and yang and balance dryness and moisture."

[0029] This formula does not include any guiding herbs in the traditional sense. The above eight core herbs constitute a complete "principal → assistant → adjuvant" treatment system, requiring no additional guiding or harmonizing herbs.

[0030] Furthermore, this invention also provides a traditional Chinese medicine compound for treating orthopedic conditions caused by liver and kidney deficiency, prepared by mixing the above-mentioned traditional Chinese medicine composition with water. The compound allows the medicine to exist in a solution state, requiring no disintegration after oral administration and resulting in rapid absorption, making it particularly suitable for the clinical needs of patients in the acute phase of orthopedic injuries requiring rapid onset of action. It also eliminates the inconvenience of traditional decoction preparation, is convenient to carry, provides accurate dosage, and significantly improves patient compliance. The use of purified water as a pharmaceutical excipient ensures the safety of the preparation.

[0031] The relative density of the herbal compound is 1.02~1.08 (80℃±2℃), the pH value is 4.0~6.0, and each 1ml contains 0.12~0.18mg of icariin. The relative density of 1.02~1.08 (80℃±2℃) reflects a reasonable range of solid content, ensuring moderate concentration of active ingredients and good fluidity; the pH value of 4.0~6.0 ensures the acid-base stability of the preparation and inhibits microbial growth; the 0.12~0.18mg of icariin per 1ml provides a direct and quantifiable control standard for the accuracy of the dosage and extraction transfer rate of the principal ingredient, epimedium, upgrading product quality from "experience-based judgment" to "data-driven control," significantly improving quality controllability.

[0032] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine compound, comprising: S1. Mix Epimedium, Dipsacus asper, Drynaria fortunei, Rehmannia glutinosa, Morinda officinalis, Eucommia ulmoides, vinegar-processed tortoise shell, and calcined oyster shell to obtain a mixture; S2. Mix the mixture with water, extract, and decoct to obtain a decoction; S3. Concentrate the decoction to a relative density of 1.02~1.08 (80℃±2℃) to obtain a concentrated solution; S4. Mix the concentrated solution and sodium benzoate, and add the remaining water to prepare a traditional Chinese medicine compound.

[0033] This method has a simple process and clear operation. It can be implemented using conventional equipment in the field of traditional Chinese medicine preparations and is easy to scale up industrially. By fully extracting the water-soluble effective components from the medicinal materials through water extraction, and then concentrating and preparing them to obtain a uniform and stable liquid preparation, the entire process from raw materials to finished products can be controlled.

[0034] Furthermore, in step S2, the extraction temperature is 60~80℃. Soaking the mixture within this temperature range effectively softens the medicinal material tissue, expands the cell walls, and promotes the diffusion of active ingredients from the cells into the extraction solvent, creating favorable conditions for full dissolution during subsequent boiling and decoction.

[0035] Further, in step S2, the mixture is first mixed with 6-8 times its volume of water, extracted for 20-40 minutes, then boiled and decocted for 1.2-1.5 hours. The first decoction is then filtered and collected. The dregs are then mixed with 4-6 times their volume of water, boiled and decocted for 0.8-1.2 hours, filtered, and the second decoction is collected. The two decoctions are then combined. This decoction method maximizes the utilization rate of the medicinal materials, and the extraction and transfer rate of effective components is significantly higher than that of single-time decoction or conventional water decoction processes.

[0036] Furthermore, in step S3, the decoction is concentrated under a vacuum of -0.06 to -0.08 MPa and a temperature of 70 to 80°C. Vacuum low-temperature concentration significantly lowers the liquid's boiling point, effectively removing moisture while minimizing the thermal degradation of heat-sensitive components such as icariin, thus preserving the bioactivity of the active ingredients. Moreover, this parameter window offers moderate operational flexibility, facilitating on-site production control.

[0037] Further, in step S4, the concentrate is first mixed with 45%–55% of the total volume of water and stirred for 20–40 minutes; then water is added to 90%–98% of the total volume, sodium benzoate is added, and then water is added to the final volume to obtain the herbal compound. This step allows the high-concentration concentrate to be gradually diluted, avoiding protein denaturation or precipitation caused by directly mixing in a large amount of water; the subsequent addition of sodium benzoate helps the preservative to fully dissolve and evenly distribute at a higher concentration, ensuring that the preservative effect covers the entire batch; finally, water is added to the final volume, ensuring the accuracy of the finished product's volume and concentration, and ensuring a highly consistent content of active ingredients in each bottle of the compound.

[0038] Furthermore, after the herbal mixture is allowed to stand for 10-15 hours, it is filtered and then filled into bottles. Standing allows fine suspended particles and colloidal impurities in the liquid to settle completely; filtration removes sediment and insoluble particles, making the mixture clear and transparent, significantly improving the product's storage stability and appearance quality, and avoiding concerns from patients due to sedimentation at the bottom of the bottle after filling.

[0039] The features and performance of the present invention will be further described in detail below with reference to embodiments.

[0040] Example 1

[0041] This embodiment provides a traditional Chinese medicine composition for treating orthopedic conditions caused by liver and kidney deficiency, the raw materials of which include: Epimedium 91g, Dipsacus asper 91g, Drynaria fortunei 78g, Rehmannia glutinosa 117g, Morinda officinalis 78g, Eucommia ulmoides 78g, Vinegar-processed tortoise shell 91g, Calcined oyster shell 91g, Sodium benzoate 7.8g.

[0042] The above-mentioned traditional Chinese medicine composition was prepared into a traditional Chinese medicine compound according to the following preparation method: S1. Mix the above eight kinds of Chinese medicinal herbs to obtain a mixture.

[0043] S2. Put the mixture into a multi-functional extraction tank, add 8 times the amount of the medicinal materials (about 52000ml) of purified water, heat to 70℃ and soak for 30 minutes, then boil and decoct for 1.5 hours, filter and collect the first decoction; add 6 times the amount of the medicinal materials (about 39000ml) of purified water to the residue, boil and decoct for 1.0 hour, filter and collect the second decoction, combine the two decoctions, the total decoction is about 85000ml.

[0044] S3. Transfer the combined liquid to the external circulation evaporator and concentrate it to a relative density of 1.05 (80℃±2℃) under vacuum of -0.07MPa and temperature of 75℃, to obtain approximately 30,000ml of concentrated liquid.

[0045] S4. Add purified water to the mixing tank to 50% of the total volume (approximately 13000 ml), add the concentrate, and stir for 30 minutes; then add purified water to 95% of the total volume (approximately 24700 ml), add 7.8 g of sodium benzoate, stir to dissolve, add purified water to the total volume of 26000 ml, let stand for 12 hours, filter, and fill into 200 ml oral liquid pharmaceutical high-density polyethylene bottles, cap and seal, obtaining a total of 130 bottles.

[0046] The product characteristics are as follows: Appearance: Brownish-brown clear liquid with a bitter and slightly sweet taste.

[0047] Relative density: 1.05 (80℃±2℃) pH value: 5.2 Icariin content: 0.16 mg / ml (determined by HPLC, chromatographic conditions omitted). Microbial limits: Compliant with the provisions of the Compound Preparations section of the Chinese Pharmacopoeia.

[0048] Example 2

[0049] This embodiment provides a traditional Chinese medicine composition for treating orthopedic conditions caused by liver and kidney deficiency, the raw materials of which include: Epimedium 80g, Dipsacus asper 80g, Drynaria fortunei 70g, Rehmannia glutinosa 110g, Morinda officinalis 70g, Eucommia ulmoides 70g, Vinegar-processed tortoise shell 80g, Calcined oyster shell 80g, Sodium benzoate 7g.

[0050] The above-mentioned traditional Chinese medicine composition was prepared into a traditional Chinese medicine compound according to the following preparation method: S1. Mix the above eight kinds of Chinese medicinal herbs to obtain a mixture.

[0051] S2. Add 6 times the amount of purified water to the medicinal materials, heat to 60℃ and soak for 20 minutes, boil and decoct for 1.2 hours, then filter; add 4 times the amount of water to the dregs, boil and decoct for 0.8 hours, filter, and combine the decoctions.

[0052] S3. Concentrate to a relative density of 1.02 (80℃±2℃) under a vacuum of -0.06MPa and a temperature of 70℃.

[0053] S4. First, add purified water to prepare 45% of the total volume and stir for 20 minutes; then add to 90%, add sodium benzoate, add water to make up to 25000ml, let stand for 10 hours, filter, and fill into 180ml / bottle.

[0054] The product characteristics are as follows: Relative density: 1.03 (80℃±2℃) pH value: 4.5 Icariin content: 0.13 mg / ml Microbial limits: Compliant with regulations.

[0055] Example 3

[0056] This embodiment provides a traditional Chinese medicine composition for treating orthopedic conditions caused by liver and kidney deficiency, the raw materials of which include: Prepare a 27,000ml traditional Chinese medicine mixture by mixing 100g of Epimedium, 100g of Dipsacus asper, 85g of Drynaria fortunei, 125g of Rehmannia glutinosa, 85g of Morinda officinalis, 85g of Eucommia ulmoides, 100g of vinegar-processed tortoise shell, 100g of calcined oyster shell, and 9g of sodium benzoate with an appropriate amount of purified water.

[0057] The above-mentioned traditional Chinese medicine composition was prepared into a traditional Chinese medicine compound according to the following preparation method: S1. Mix the above eight kinds of Chinese medicinal herbs to obtain a mixture.

[0058] S2. Add 8 times the amount of purified water to the medicinal materials, heat to 80℃ and soak for 40 minutes, boil and decoct for 1.5 hours, then filter; add 6 times the amount of water to the dregs, boil and decoct for 1.2 hours, filter, and combine the decoctions.

[0059] S3. Concentrate to a relative density of 1.08 (80℃±2℃) under a vacuum of -0.08MPa and a temperature of 80℃.

[0060] S4. First, add 55% purified water to the total volume and stir for 40 minutes; then add water to 98%, add sodium benzoate, add water to the total volume of 27000ml, let stand for 15 hours, filter, and fill into 220ml / bottle.

[0061] The product characteristics are as follows: Relative density: 1.07 (80℃±2℃) pH value: 5.8 Icariin content: 0.17 mg / ml Microbial limits: Compliant with regulations.

[0062] Test case One hundred diagnosed patients were selected at Huaxian Orthopedic Hospital, including 42 with lumbar disc herniation, 36 with primary osteoporosis, and 22 with degenerative osteoarthritis. All patients met the TCM diagnostic criteria for "Liver and Kidney Deficiency Syndrome" in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine" (primary symptoms: lower back pain and weakness in the lower limbs; secondary symptoms: dizziness and tinnitus, brittle bones; tongue and pulse: pale tongue with white coating, deep and thready pulse).

[0063] Each patient should take 20 ml of the herbal mixture prepared in Example 1 of this invention (200 ml per bottle) orally, three times a day, after meals. The treatment period is 4 weeks.

[0064] Follow-up visits will be conducted by phone or in an outpatient clinic after the medication cycle is completed. Patients will rate the overall effectiveness on a scale of 0 to 5 based on their own feelings. 0 points: Ineffective - Symptoms show no improvement or may even worsen.

[0065] 1 point: Slight improvement - Occasional relief but still significantly affects daily life.

[0066] 2 points: Mild improvement - Symptoms have been relieved, but some activities are still limited.

[0067] 3 points: Moderate improvement - Major symptoms have significantly improved, and daily life is basically unaffected.

[0068] 4 points: Significant improvement - Symptoms have basically disappeared, with only slight discomfort after exertion.

[0069] 5 points: Excellent effect - symptoms completely disappear and normal activities are restored.

[0070] The scoring results are shown in Table 1.

[0071] Table 1. Efficacy Rating Table of Traditional Chinese Medicine Compositions Lumbar disc herniation 42 40 3.85 82.5%（33 / 40） Osteoporosis 36 34 4.12 88.2%（30 / 34） Degenerative osteoarthritis 22 21 3.76 76.2%（16 / 21） total 100 95 3.92 83.2%（79 / 95） As shown in Table 1, among the 95 patients who were successfully followed up, the average comprehensive efficacy score was 3.92 out of 5, with 83.2% of patients scoring ≥3 (moderate or better improvement). Patients with all three indications gave an average score of 3.7 or higher, with the most significant improvement observed in osteoporosis patients (average score 4.12). These results demonstrate that the traditional Chinese medicine composition and preparation method of this invention have a clear effect on improving patient symptoms in clinical practice and enjoy high patient satisfaction.

[0072] Typical Case Feedback Case 1 Patient A (female, 62 years old, osteoporosis): Before medication, her VAS score for lower back pain was 7, and she had difficulty walking; after 4 weeks of medication, her VAS score dropped to 2, and she could walk for 30 minutes on her own, scoring 5.

[0073] Case 2 Patient B (male, 48 years old, lumbar disc herniation): Before medication, he had significant radiating pain in his right lower limb, rated 3 points; after 4 weeks of medication, the pain basically disappeared and he returned to his daily work, rated 4 points.

[0074] In summary, this invention provides a traditional Chinese medicine composition, a compound preparation, and its preparation method for treating orthopedic conditions caused by liver and kidney deficiency. The composition comprises Epimedium, Dipsacus, Drynaria, Rehmannia glutinosa, Morinda officinalis, Eucommia ulmoides, vinegar-processed tortoise shell, calcined oyster shell, and sodium benzoate in specific weight proportions. The composition has a clear principal-assistant-adjuvant structure, tonifying both Yin and Yang. It is highly targeted at orthopedic conditions caused by liver and kidney deficiency, such as lower back pain, lower limb atrophy, difficulty walking, dizziness, tinnitus, brittle bones, lumbar disc herniation, and osteoporosis, demonstrating definite clinical efficacy. The preparation method sets scientifically reasonable parameter ranges for extraction, concentration, and formulation processes. It employs a two-step decoction combined with vacuum low-temperature concentration and step-by-step water addition, ensuring the full dissolution and stable transfer of effective components such as icariin while avoiding damage to heat-sensitive components, thus ensuring consistent and controllable quality across different batches. The final herbal compound requires no disintegration, is rapidly absorbed orally, has a quick onset of action, is convenient to carry, provides accurate dosage, and enjoys high patient compliance. The product also specifies quantitative indicators such as relative density, pH value, and icariin content, further ensuring quality control and safety. The combination of this specific formulation and parameterized process produces an unexpected synergistic effect, which is not readily apparent. Furthermore, the process is compatible with conventional equipment, facilitating large-scale industrial production, and possesses significant clinical application value and social benefits.

[0075] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating bone and joint injuries caused by liver and kidney deficiency, characterized in that, The raw materials, by weight, include: Epimedium 80-100 parts, Dipsacus asper 80-100 parts, Drynaria fortunei 70-85 parts, Rehmannia glutinosa 110-125 parts, Morinda officinalis 70-85 parts, Eucommia ulmoides 70-85 parts, vinegar-processed tortoise shell 80-100 parts, calcined oyster shell 80-100 parts, and sodium benzoate 7-9 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials, by weight, comprise: Epimedium 85-95 parts, Dipsacus asper 85-95 parts, Drynaria fortunei 75-82 parts, Rehmannia glutinosa 115-122 parts, Morinda officinalis 75-82 parts, Eucommia ulmoides 75-82 parts, Vinegar-processed tortoise shell 85-95 parts, Calcined oyster shell 85-95 parts, Sodium benzoate 7.5-8.5 parts.

3. A traditional Chinese medicine compound for treating bone and joint injuries caused by liver and kidney deficiency, characterized in that, It is prepared by mixing the traditional Chinese medicine composition according to claim 1 or 2 with water.

4. The traditional Chinese medicine compound according to claim 3, characterized in that, The relative density of the herbal compound is 1.02~1.08 (80℃±2℃), the pH value is 4.0~6.0, and each 1ml contains 0.12~0.18mg of icariin.

5. A method for preparing a traditional Chinese medicine compound as described in claim 3 or 4, characterized in that, include: S1. Mix the Epimedium, Dipsacus asper, Drynaria fortunei, Rehmannia glutinosa, Morinda officinalis, Eucommia ulmoides, vinegar-processed tortoise shell, and calcined oyster shell to obtain a mixture; S2. The mixture is mixed with water and then extracted and decocted to obtain a decoction; S3. Concentrate the decoction to a relative density of 1.02~1.08 (80℃±2℃) to obtain a concentrated solution; S4. Mix the concentrated liquid and the sodium benzoate, and add the remaining water to prepare the traditional Chinese medicine compound.

6. The preparation method according to claim 5, characterized in that, In step S2, the extraction temperature is 60~80℃.

7. The preparation method according to claim 6, characterized in that, In step S2, the mixture is first mixed with 6 to 8 times the amount of water, extracted for 20 to 40 minutes, boiled and decocted for 1.2 to 1.5 hours, filtered and collected as the first decoction; the dregs are then added to 4 to 6 times the amount of water of the mixture, boiled and decocted for 0.8 to 1.2 hours, filtered and collected as the second decoction, and the two decoctions are combined.

8. The preparation method according to claim 7, characterized in that, In step S3, the decoction is concentrated under a vacuum of -0.06 to -0.08 MPa and a temperature of 70 to 80°C.

9. The preparation method according to claim 8, characterized in that, In step S4, the concentrated liquid is first mixed with 45% to 55% of the total volume of water and stirred for 20 to 40 minutes; then water is added to 90% to 98% of the total volume, sodium benzoate is added, and water is added to the full volume to obtain the traditional Chinese medicine compound.

10. The preparation method according to claim 9, characterized in that, After the herbal mixture is left to stand for 10-15 hours, it is filtered and then bottled.