Traditional Chinese medicine composition with functions of tonifying kidney and strengthening essence as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition with kidney tonifying and essence strengthening functions and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition with the kidney tonifying and essence strengthening functions is prepared from the following raw materials in parts by weight: 8 to 22 parts of antler slices, 5 to 15 parts of prepared radix aconiti lateralis preparata slices, 8 to 23 parts of herba epimedii, 5 to 15 parts of radix morindae officinalis, 5 to 15 parts of herba cistanche, 8 to 22 parts of radix rehmanniae preparata, 8 to 22 parts of tribulus terrestris, 5 to 15 parts of turtle shells, 8 to 22 parts of tortoise shells, 5 to 15 parts of radix angelicae sinensis, 8 to 22 parts of fructus lycii, 3 to 9 parts of flos caryophylli, 15 to 45 parts of radix astragali seu hedysari, 5 to 15 parts of rhizoma polygonati and 3 to 7 parts of sun-dried ginseng. The traditional Chinese medicine composition is decocted with water to obtain a decoction, after the traditional Chinese medicine composition is administrated to a patient with oligospermia or asthenospermia, the semen quality of the patient can be effectively improved, the sperm density is improved, the sperm motility rate and the normal sperm form proportion are increased, and the problem of male infertility is solved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions, its preparation method, and its application. Background Technology

[0002] The etiology and pathogenesis of oligospermia can be broadly categorized into kidney deficiency and pathogenic factors. Kidney deficiency leads to reduced sperm production; pathogenic factors include damp-heat damaging kidney essence or phlegm and blood stasis obstructing the seminal pathway, resulting in low sperm count. Asthenospermia, on the other hand, is often caused by congenital deficiency or excessive sexual activity, leading to insufficient kidney essence, kidney yang deficiency, and weakened kidney fire, which fails to warm the reproductive essence in the kidneys, resulting in insufficient sperm motility. Alternatively, it may be caused by a diet high in fatty and sweet foods, tea, and alcohol, coupled with damp-heat accumulating in the liver meridian and disturbing the seminal chamber, resulting in abnormal reproductive essence and decreased sperm motility. Or, it may be caused by prolonged illness and physical weakness, resulting in insufficient qi and blood, malnourishment of the essence, and low sperm motility.

[0003] Currently, commonly used medications for treating oligospermia or asthenospermia include traditional Chinese medicines that tonify the kidneys, strengthen sperm, replenish qi and blood, promote blood circulation and remove blood stasis, and clear heat and detoxify. However, the traditional Chinese medicine combinations currently used to treat oligospermia or asthenospermia generally suffer from insignificant or slow efficacy. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition with the function of tonifying the kidney and replenishing essence, which can effectively improve sperm quality by promoting blood circulation, tonifying the kidney and replenishing essence.

[0005] This invention provides a traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions, comprising the following raw materials in parts by weight: 8-22 parts of deer antler slices, 5-15 parts of prepared aconite root, 8-23 parts of epimedium, 5-15 parts of morinda root, 5-15 parts of cistanche, 8-22 parts of prepared rehmannia root, 8-22 parts of tribulus terrestris, 5-15 parts of turtle shell, 8-22 parts of tortoise shell, 5-15 parts of angelica root, 8-22 parts of wolfberry fruit, 3-9 parts of clove, 15-45 parts of astragalus root, 5-15 parts of polygonatum rhizome, and 3-7 parts of raw ginseng.

[0006] Preferably, the raw materials include the following parts by weight: 10-20 parts of deer antler slices, 8-12 parts of prepared aconite root slices, 10-20 parts of epimedium, 8-12 parts of morinda root, 8-12 parts of cistanche, 10-20 parts of prepared rehmannia root, 10-20 parts of tribulus terrestris, 8-12 parts of turtle shell, 10-20 parts of tortoise shell, 8-12 parts of angelica root, 10-20 parts of wolfberry fruit, 4-7 parts of clove, 20-40 parts of astragalus root, 8-12 parts of polygonatum rhizome, and 4-6 parts of raw ginseng.

[0007] Preferably, the raw materials include the following parts by weight: 15 parts deer antler slices, 10 parts prepared aconite root slices, 15 parts epimedium, 10 parts morinda root, 10 parts cistanche, 15 parts prepared rehmannia root, 15 parts tribulus terrestris, 10 parts turtle shell, 15 parts tortoise shell, 10 parts angelica root, 15 parts wolfberry, 5 parts clove, 30 parts astragalus root, 10 parts polygonatum rhizome, and 5 parts sun-dried ginseng.

[0008] Preferably, it also includes at least two of the following raw materials in parts by weight: 10-30 parts of charred hawthorn, 8-22 parts of Shenqu (a type of medicinal fermentation), 5-15 parts of malt, 5-15 parts of Epimedium, 5-15 parts of leek seeds, 8-22 parts of Taxillus chinensis, and 5-15 parts of Eucommia ulmoides.

[0009] This invention provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: The raw materials described in the above technical solution are decocted with water, and the decoction is separated to obtain a traditional Chinese medicine composition.

[0010] Preferably, the mass ratio of the raw material to water is 1:2 to 1:3.

[0011] Preferably, the simmering process ends when the total volume of the ingredients and water is reduced to half.

[0012] This invention provides the use of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method in the preparation of drugs for the prevention and / or treatment of oligospermia and / or asthenospermia.

[0013] Preferably, the oligospermia and / or asthenospermia include kidney qi deficiency syndrome, kidney essence deficiency syndrome, or kidney yang deficiency syndrome.

[0014] Preferably, the drug comprises at least one of the following oral preparations: decoction, pill, drop pill, capsule, granule, tablet and oral liquid.

[0015] This invention provides a traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions, comprising the following raw materials in parts by weight: 8-22 parts deer antler slices, 5-15 parts prepared aconite root, 8-23 parts epimedium, 5-15 parts morinda root, 5-15 parts cistanche, 8-22 parts prepared rehmannia root, 8-22 parts tribulus terrestris, 5-15 parts turtle shell, 8-22 parts tortoise shell, 5-15 parts angelica root, 8-22 parts wolfberry fruit, 3-9 parts clove, 15-45 parts astragalus root, 5-15 parts polygonatum rhizome, and 3-7 parts raw ginseng. This invention heavily utilizes deer antler slices to replenish kidney essence and promote sperm production, serving as the principal ingredient; prepared aconite root warms and tonifies kidney yang, and together they serve as the principal ingredients. Cistanche deserticola, Morinda officinalis, and Epimedium are used as assistant herbs. The kidneys are the foundation of innate essence, and these three herbs work together to treat the root cause. Epimedium, Morinda officinalis, and Cistanche deserticola can tonify both Yin and Yang, compensating for the insufficient energy-replenishing capacity of the principal herbs. Rehmannia glutinosa, Lycium barbarum, Trionyx sinensis, Tortoise shell, and Tribulus terrestris are used as adjuvant herbs. Rehmannia glutinosa has the effects of tonifying the kidneys and replenishing essence, anti-oxidation, and enhancing immunity. Lycium barbarum gently replenishes liver blood and kidney essence. Trionyx sinensis and Tortoise shell can both benefit the kidneys, nourish Yin, and subdue Yang. Tribulus terrestris can soothe the liver, relieve depression, invigorate blood, and dispel wind. Astragalus membranaceus, Polygonatum sibiricum, and Panax ginseng are used as adjuvant herbs, working together to invigorate Qi and strengthen the spleen. Angelica sinensis and Syzygium aromaticum are used as guiding herbs. Angelica sinensis invigorates and replenishes blood, while Syzygium aromaticum warms Yang and promotes Qi circulation. The entire formula works together to invigorate blood, tonify the kidneys, and replenish essence. This herbal combination is effective for kidney Qi deficiency, kidney essence deficiency, and kidney Yang deficiency. Clinical administration results showed that the traditional Chinese medicine composition could improve semen quality, sperm motility and sperm morphology within 2 months, with a total effective rate of over 85%. Attached Figure Description

[0016] Figure 1 The results show a comparison of sperm concentration before and after treatment in patients; Figure 2 The results of comparing the patient's semen volume before and after treatment; Figure 3 The results of comparing sperm DNA fragmentation rate, grade a sperm ratio, and a+b sperm ratio before and after treatment were presented. Figure 4 This is a statistical chart showing the clinical efficacy of a traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions. Figure 5 The results show the comparison of semen volume before and after treatment in the experimental group and the control group; Figure 6 The results show the comparison of sperm concentration and sperm motility before and after treatment in the experimental group and the control group. Figure 7 The results show the comparison of the proportions of grade a sperm and a+b sperm before and after treatment in the experimental group and the control group. Detailed Implementation

[0017] This invention provides a traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions, comprising the following raw materials in parts by weight: 8-22 parts of deer antler slices, 5-15 parts of prepared aconite root, 8-23 parts of epimedium, 5-15 parts of morinda root, 5-15 parts of cistanche, 8-22 parts of prepared rehmannia root, 8-22 parts of tribulus terrestris, 5-15 parts of turtle shell, 8-22 parts of tortoise shell, 5-15 parts of angelica root, 8-22 parts of wolfberry fruit, 3-9 parts of clove, 15-45 parts of astragalus root, 5-15 parts of polygonatum rhizome, and 3-7 parts of raw ginseng.

[0018] In this invention, the traditional Chinese medicine composition preferably comprises the following raw materials in parts by weight: 10-20 parts of deer antler slices, 8-12 parts of prepared aconite root slices, 10-20 parts of epimedium, 8-12 parts of morinda root, 8-12 parts of cistanche, 10-20 parts of prepared rehmannia root, 10-20 parts of tribulus terrestris, 8-12 parts of turtle shell, 10-20 parts of tortoise shell, 8-12 parts of angelica root, 10-20 parts of wolfberry fruit, and 4-7 parts of clove. The composition comprises 20-40 parts Astragalus membranaceus, 8-12 parts Polygonatum sibiricum, and 4-6 parts raw ginseng. More preferably, it includes the following ingredients in parts by weight: 15 parts deer antler slices, 10 parts prepared Aconitum carmichaelii, 15 parts Epimedium brevicornu, 10 parts Morinda officinalis, 10 parts Cistanche deserticola, 15 parts prepared Rehmannia glutinosa, 15 parts Tribulus terrestris, 10 parts turtle shell, 15 parts tortoise shell, 10 parts Angelica sinensis, 15 parts Lycium barbarum, 5 parts cloves, 30 parts Astragalus membranaceus, 10 parts Polygonatum sibiricum, and 5 parts raw ginseng. This invention does not impose special restrictions on the source of the raw materials in the herbal composition; any source of herbal raw materials well-known in the art can be used. In the embodiments of this invention, all raw materials in the herbal composition were purchased from the Traditional Chinese Medicine Pharmacy of Shanghai Seventh People's Hospital.

[0019] In this invention, the traditional Chinese medicine composition is based on the principle of invigorating blood, tonifying the kidneys, and replenishing essence. Deer antler slices are used in large quantities to replenish kidney essence and promote sperm production; these are the principal herbs. Prepared aconite root warms and tonifies kidney yang; together they are the principal herbs. Cistanche deserticola, Morinda officinalis, and Epimedium are the assistant herbs. The kidneys are the foundation of innate essence; the three herbs work together to treat the root cause. Epimedium, Morinda officinalis, and Cistanche deserticola can tonify both yin and yang, compensating for the insufficient energy replenishment of the principal herbs. Rehmannia glutinosa, wolfberry, turtle shell, tortoise shell, and tribulus terrestris are all adjuvant herbs. Rehmannia glutinosa has the effects of tonifying the kidney and replenishing essence, anti-oxidation, and enhancing immunity. Wolfberry gently replenishes liver blood and kidney essence. Turtle shell and tortoise shell can both benefit the kidney, nourish yin and subdue yang. Tribulus terrestris can soothe the liver, relieve depression, invigorate blood and dispel wind. Astragalus membranaceus, polygonatum sibiricum, and ginseng are adjuvant herbs, which together exert the effects of invigorating qi and strengthening the spleen. Angelica sinensis and clove are guiding herbs. Angelica sinensis invigorates blood and replenishes blood, while clove warms yang and promotes qi circulation. The whole formula works together to invigorate blood, tonify the kidney and replenish essence.

[0020] In this invention, to address the different symptoms exhibited by different patients after taking the traditional Chinese medicine composition, at least two of the following traditional Chinese medicine ingredients by weight can be added: 10-30 parts of charred hawthorn, 8-22 parts of Shenqu (medicated leaven), 5-15 parts of malt, 5-15 parts of Epimedium, 5-15 parts of leek seed, 8-22 parts of Taxillus chinensis, and 5-15 parts of Eucommia ulmoides. When patients experience symptoms of loss of appetite or poor digestion after taking the medicine, 15-25 parts of charred hawthorn, 10-20 parts of Shenqu, and 8-12 parts of malt are added to the formula of the traditional Chinese medicine composition; more preferably, 20 parts of charred hawthorn, 15 parts of Shenqu, and 10 parts of malt are added. When patients experience symptoms of a pale red tongue, white coating, and weak pulse after taking the medicine, 15-25 parts of charred hawthorn and 10-20 parts of Shenqu are added to the formula of the traditional Chinese medicine composition; more preferably, 20 parts of charred hawthorn and 15 parts of Shenqu are added. When a patient experiences decreased libido after taking the medication, add 8-12 parts of Epimedium and 8-12 parts of Allium tuberosum seeds to the formula of the traditional Chinese medicine composition, preferably 10 parts of Epimedium and 10 parts of Allium tuberosum seeds. When a patient exhibits a pale red tongue, thin white coating, and thready pulse after taking the medication, add 10-20 parts of Taxillus chinensis and 8-12 parts of Eucommia ulmoides to the formula of the traditional Chinese medicine composition, preferably 15 parts of Taxillus chinensis and 10 parts of Eucommia ulmoides.

[0021] This invention provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: The raw materials described in the above technical solution are boiled in water, and the decoction is separated to obtain the decoction liquid.

[0022] In this invention, the preferred temperature for decocting is 90-100°C, more preferably 95-100°C. The preferred mass ratio of the raw materials to water is 1:2 to 1:3. The decocting is preferably stopped when the total volume of the raw materials and water is half full.

[0023] In this invention, when the traditional Chinese medicine composition also includes other raw materials, it is preferable to mix the other raw materials with the raw materials and decoct them together.

[0024] This invention provides the use of the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the preparation method in the preparation of drugs for the prevention and / or treatment of oligospermia and / or asthenospermia.

[0025] In this invention, the oligospermia and / or asthenospermia preferably include kidney qi deficiency syndrome, kidney essence deficiency syndrome, or kidney yang deficiency syndrome.

[0026] In this invention, the drug preferably comprises at least one of the following oral preparations: decoction, pill, drop pill, capsule, granule, tablet, and oral liquid. This invention does not impose any particular limitation on the preparation method of the drug; any drug preparation method well known in the art can be used. The preferred method of administration is twice daily for three consecutive courses of treatment. The first two courses consist of 14 doses, and the final course consists of 30 doses, each dose being 200ml. During the use of this drug, it is recommended that the user maintain a regular daily routine, engage in appropriate exercise, keep a relaxed mood, and avoid alcohol and spicy foods.

[0027] In this invention, the traditional Chinese medicine composition can improve the patient's semen quality, increase sperm density, increase sperm motility, and increase the proportion of normal sperm morphology within 2 months, effectively solving the problem of male infertility.

[0028] The following detailed description, in conjunction with embodiments, illustrates a traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions, its preparation method, and its application. However, these descriptions should not be construed as limiting the scope of protection of this invention.

[0029] Example 1 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 15g deer antler slices, 10g prepared aconite root slices, 15g epimedium, 10g morinda root, 10g cistanche, 15g prepared rehmannia root, 15g tribulus terrestris, 10g turtle shell, 15g tortoise shell, 10g angelica root, 15g wolfberry, 6g clove, 30g astragalus root, 10g polygonatum rhizome, and 5g sun-dried ginseng.

[0030] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0031] Example 2 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 10g deer antler slices, 15g prepared aconite root slices, 8g epimedium, 15g morinda root, 5g cistanche, 25g prepared rehmannia root, 10g tribulus terrestris, 15g turtle shell, 10g tortoise shell, 15g angelica root, 8g wolfberry, 9g clove, 15g astragalus root, 15g polygonatum rhizome, and 3g sun-dried ginseng.

[0032] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0033] Example 3 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 22g deer antler slices, 5g prepared aconite root slices, 22g epimedium, 5g morinda root, 15g cistanche, 8g prepared rehmannia root, 22g tribulus terrestris, 5g turtle shell, 22g tortoise shell, 5g angelica root, 22g wolfberry, 3g clove, 40g astragalus root, 5g polygonatum rhizome, and 7g sun-dried ginseng.

[0034] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0035] Example 4 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 15g deer antler slices, 10g prepared aconite root slices, 15g epimedium, 10g morinda root, 10g cistanche, 15g prepared rehmannia root, 15g tribulus terrestris, 10g turtle shell, 15g tortoise shell, 10g angelica root, 15g wolfberry, 6g clove, 30g astragalus root, 10g polygonatum rhizome, 5g raw ginseng, 20g charred hawthorn, 15g medicated leaven, and 10g malt.

[0036] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0037] Example 5 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 15g deer antler slices, 10g prepared aconite root slices, 15g epimedium, 10g morinda root, 10g cistanche, 15g prepared rehmannia root, 15g tribulus terrestris, 10g turtle shell, 15g tortoise shell, 10g angelica root, 15g wolfberry, 6g clove, 30g astragalus root, 10g polygonatum rhizome, 5g sun-dried ginseng, 10g charred hawthorn, and 10g medicated leaven.

[0038] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0039] Example 6 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 15g deer antler slices, 10g prepared aconite root slices, 15g epimedium, 10g morinda root, 10g cistanche, 15g prepared rehmannia root, 15g tribulus terrestris, 10g turtle shell, 15g tortoise shell, 10g angelica root, 15g wolfberry, 6g clove, 30g astragalus root, 10g polygonatum rhizome, 5g raw ginseng, 10g epimedium, and 10g leek seed.

[0040] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0041] Example 7 A method for preparing Guifu Yishen Decoction with kidney-tonifying and essence-replenishing functions 1. Formula: 15g deer antler slices, 10g prepared aconite root slices, 15g epimedium, 10g morinda root, 10g cistanche, 15g prepared rehmannia root, 15g tribulus terrestris, 10g turtle shell, 15g tortoise shell, 10g angelica root, 15g wolfberry, 6g clove, 30g astragalus root, 10g polygonatum rhizome, 5g raw ginseng, 15g mulberry mistletoe, and 10g eucommia bark.

[0042] 2. Accurately weigh each ingredient in the formula in step 1, crush them, add twice the amount of water and decoct until the volume is reduced to half. Separate the decoction to obtain Gui Fu Yi Shen Tang.

[0043] Example 8 Clinical trials Forty patients diagnosed with asthenospermia in the hospital were also diagnosed with infertility using Traditional Chinese Medicine (TCM). All 40 patients were given Gui Fu Yi Shen Tang (Gui Fu Yi Shen Tang) prepared in Example 1, 100ml twice daily, for three courses of treatment. Instructions included: regulating daily life, appropriate exercise, maintaining a relaxed mood, and avoiding alcohol and spicy foods.

[0044] The efficacy of treatment was assessed according to the WHO Manual of Laboratory Testing for Human Semen and Sperm-Cervical Mucus (Fourth Edition), and the criteria for judging efficacy are as follows: Cured: The spouse conceived after treatment; Significant effect: After treatment, the proportion of (a+b) grade sperm is ≥50% or the proportion of grade a sperm is ≥25%; Effective: After treatment, the proportion of (a+b) grade sperm or the proportion of grade a sperm increases by more than 30%; Ineffective: No significant improvement or even deterioration was observed in any of the sperm test indicators; Overall effective rate = (number of cured cases + number of cases with significant effect + number of cases with effect) / total number of cases × 100%.

[0045] Statistical results analysis: After treatment, the patient's semen volume, sperm concentration, sperm motility, proportion of grade A+B sperm, proportion of grade A sperm, number of sperm with normal morphology, and sperm DNA fragmentation rate all improved compared to before treatment, and the differences were statistically significant. P <0.001). See Tables 1-3 and Figures 1-3 .

[0046] Table 1 Comparison of routine semen parameters before and after treatment ( )

[0047] Note: Comparison within the group, compared with that before treatment ＊ P <0.001 Table 2 Comparison of routine semen parameters of patients before and after treatment ( )

[0048] Note: Comparison within the group, compared with that before treatment ＊ P <0.001.

[0049] Table 3 Comparison of routine semen parameters of patients before and after treatment ( )

[0050] Note: Comparison within the group, compared with that before treatment ＊ P <0.001.

[0051] After statistics, among 40 patients with asthenozoospermia, 3 were cured (7.5%), 20 showed marked efficacy (50%), 11 were effective (27.5%), and 6 were ineffective (15%). The total effective rate reached 85%. See Table 4 and Figure 4 .

[0052] Table 4 Statistical table of clinical effective rate of a traditional Chinese medicine composition with the function of tonifying the kidney and replenishing essence

[0053] Example 9 Clinical trial Forty patients with oligospermia diagnosed in the hospital were diagnosed with infertility by traditional Chinese medicine. The 40 patients were randomly divided into an experimental group of 20 cases and a control group of 20 cases. The experimental group was given the Guifu Yishen Decoction prepared in Example 1, twice a day, 100 ml each time, for 3 courses of treatment. The control group was given Wuzi Yanzong Pills (manufacturing company: Taichi Group Sichuan Mianyang Pharmaceutical Co., Ltd., approval number:国药准字Z20060166), twice a day, 1 bag each time, for 3 courses of treatment. Instructions: Adjust daily life, exercise appropriately, keep the mood relaxed, and avoid alcohol and spicy food.

[0054] Refer to the "WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction (Fourth Edition)" to evaluate the treatment effect. The efficacy judgment criteria are as follows: Cured: The spouse became pregnant after treatment, and the semen parameters returned to normal; Marked efficacy: The spouse did not become pregnant after treatment, but semen examination showed that the sperm concentration ≥ 15×10 6 / mL; Effective: The sperm concentration increased by ≥ 30% after treatment; Ineffective: No significant improvement or even deterioration was observed in any of the sperm test indicators; Overall effective rate = (number of cured cases + number of cases with significant effect + number of cases with effect) / total number of cases × 100%.

[0055] Statistical results analysis: There were no statistically significant differences between the two groups in semen volume, sperm concentration, sperm motility, proportion of grade A+B sperm, and proportion of grade A sperm before treatment. P >0.05), making them comparable. After treatment, both groups showed improvements in semen volume, sperm concentration, sperm motility, the proportion of grade A+B sperm, and the proportion of grade A sperm compared to before treatment; the experimental group was significantly superior to the control group in improving sperm concentration, sperm motility, the proportion of grade A+B sperm, and the proportion of grade A sperm. P <0.05 / P <0.001), but there was no statistically significant difference in semen volume between the two groups ( P >0.05). See Tables 5-7 and Figures 5-7 .

[0056] Table 5 Comparison of routine semen parameters before and after treatment in the two groups of patients ( )

[0057] Note: Within-group comparison, compared with before treatment. ＊ P <0.001; Intergroup comparison, compared with the control group # P >0.05.

[0058] Table 6 Comparison of routine semen parameters before and after treatment in the two groups of patients ( )

[0059] Note: Within-group comparison, compared with before treatment. ＊ P <0.001; Intergroup comparison, compared with the control group # P >0.05, compared with the control group ▲ P <0.05.

[0060] Table 7 Comparison of routine semen parameters before and after treatment in the two groups of patients ( )

[0061] Note: Within-group comparison, compared with before treatment. ＊ P <0.001; Intergroup comparison, compared with the control group # P>0.05, compared with the control group ▲ P <0.05, ● P <0.001.

[0062] Statistical analysis showed that the total effective rates in the control group and the experimental group were 75% and 90%, respectively. The Mann-Withney U test indicated that the clinical efficacy of the experimental group was significantly better than that of the control group (Z=-2.091). P =0.037). See Table 8.

[0063] Table 8 Comparison of clinical efficacy rates before and after treatment in the two groups of patients.

[0064] Example 10 Typical Case 1 Mr. Huang, male, 30 years old, first visit on June 11, 2019. Chief complaint: Infertility after 2 years of marriage. The patient reported normal sexual intercourse since marriage, without using contraception. His wife's gynecological and reproductive examinations were normal. Auxiliary examinations: Semen analysis showed a semen density of 130 million / ml, sperm motility of 22%, grade A+B 19%, normal sperm morphology 2%, and DNA fragmentation rate of 30%. Testicular and spermatic cord ultrasound showed normal testicular size bilaterally, no epididymal cysts, and no varicocele. Current symptoms: chest and epigastric fullness, anxiety, poor appetite, weakness in the limbs, loose stools, pale tongue with a white and greasy coating, and a thready pulse. Western medicine diagnosis: Idiopathic oligospermia; Traditional Chinese medicine diagnosis: Infertility, kidney qi deficiency syndrome. Medication: 14 doses of Gui Fu Yi Shen Tang prepared in Example 1, decocted in water and taken twice a day. Instructions: Regulate your daily routine, exercise appropriately, keep a relaxed mood, and avoid alcohol and spicy foods.

[0065] Second consultation on June 25, 2019. The patient reported that the chest and epigastric fullness and loose stools had been significantly relieved, but the patient still had poor appetite and lack of food intake. The patient was given 14 doses of Gui Fu Yi Shen Tang prepared in Example 4 to strengthen the spleen and regulate qi.

[0066] Third consultation on July 11, 2019. Semen analysis showed: semen density 165 million / ml, sperm motility 29%, grade A+B 24%. After taking the medication, the patient's mental state improved, appetite improved significantly, stools became formed, tongue was pale red with a white coating, and pulse was thready. The prescription was adjusted to 30 doses of Gui Fu Yi Shen Tang prepared in Example 5.

[0067] The patient took traditional Chinese medicine continuously for two months, paying attention to daily life and diet. Two months later, a semen analysis showed a semen density of 240 million / ml, sperm motility of 49%, grade A+B 46%, normal sperm morphology 8%, and DNA fragmentation rate of 12%. Semen quality had significantly improved. At a follow-up visit on September 1, 2019, the patient reported that his / her partner was pregnant.

[0068] Example 11 Typical Case 2 Mr. Li, male, 35 years old, first visit on May 22, 2023. Chief complaint: Infertility after 3 years of marriage. The patient reported normal sexual intercourse without discomfort; his wife's examination showed no abnormalities. Auxiliary examinations: Semen analysis showed: sperm density 110 million / mL, sperm motility 28%, grade A+B 16%. Normal sperm morphology 4%, DNA fragmentation rate 35%. Ultrasound examination: no abnormalities found in the testes, epididymis, and spermatic cord veins. Current symptoms: fatigue, weakness, soreness and weakness in the lower back and knees, frequent urination at night, pale tongue with thin white coating, and weak pulse. Western medicine diagnosis: idiopathic asthenospermia; Traditional Chinese medicine diagnosis: infertility, kidney essence deficiency syndrome. Medication: 14 doses of Gui Fu Yi Shen Tang prepared in Example 1, decocted in water and taken twice a day. Instructions: Regulate daily life, exercise appropriately, maintain a relaxed mood, and avoid alcohol and spicy foods.

[0069] Second consultation on June 5, 2023. The patient reported improvement in fatigue, weakness, soreness in the lower back and knees, and reduced nocturia, but decreased libido. 14 doses of Gui Fu Yi Shen Tang prepared in Example 6 were prescribed.

[0070] Third consultation on June 19, 2023. Semen analysis showed: sperm density 140 million / mL, sperm motility 35%, grade A+B 22%. The patient's mental state improved, libido recovered somewhat, tongue was pale red with a thin white coating, and pulse was thready. Administered 30 doses of Gui Fu Yi Shen Tang prepared in Example 7, decocted and taken as before.

[0071] The patient took traditional Chinese medicine continuously for two months, paying attention to regular rest and dietary conditioning. Two months later, a semen analysis showed a sperm density of 210 million / mL, sperm motility of 52%, grade A+B 45%, normal sperm morphology 6%, and DNA fragmentation rate of 20%. Semen quality had significantly improved. A follow-up visit on August 1, 2023, revealed that the patient's partner was pregnant.

[0072] Example 12 Typical Case 3 Mr. Yang, male, 35 years old, first visit on June 2, 2023. Chief complaint: Infertility after two years of trying to conceive. The patient reported regular sexual activity, and his wife's related examinations showed no abnormalities. Auxiliary examinations: Semen analysis showed a sperm density of 13 million / mL, sperm motility of 47%, grade A+B 54%, normal sperm morphology 3%, and DNA fragmentation rate of 21%. Ultrasound examination showed no abnormalities in the testes, epididymis, and spermatic cord veins. Current symptoms: decreased libido, occasional tinnitus, lower back and knee weakness, fatigue, aversion to cold, frequent and clear urination, pale tongue with white coating, and deep and thready pulse. Western medicine diagnosis: idiopathic oligospermia; Traditional Chinese medicine diagnosis: infertility, kidney yang deficiency syndrome. Medication: 14 doses of Gui Fu Yi Shen Tang prepared in Example 1, decocted in water and taken twice a day. Instructions: Regulate daily life, engage in appropriate exercise, maintain a relaxed mood, and avoid alcohol and spicy foods.

[0073] Second consultation on June 16, 2023. The patient reported improvement in lower back and knee pain, fatigue, and tinnitus symptoms, and increased libido, but still felt cold and had cold limbs. 14 doses of Gui Fu Yi Shen Tang prepared by 2 were administered.

[0074] Third consultation on June 30, 2023. Semen analysis showed: sperm density 17 million / mL, sperm motility 57%, grade A+B 57%. The patient's symptoms of kidney yang deficiency had improved, but recently, due to busy work, he experienced fatigue, weakness, and shortness of breath. His tongue was pale red with a thin white coating, and his pulse was thready and weak. He was prescribed 30 doses of Gui Fu Yi Shen Tang prepared in Example 3, decocted and taken as before.

[0075] The patient took traditional Chinese medicine continuously for two months, paying attention to regular rest and dietary conditioning. Two months later, a semen analysis showed a sperm density of 28 million / mL, sperm motility of 71%, grade A+B 64%, normal sperm morphology 4%, and DNA fragmentation rate of 16%. Semen quality had significantly improved. A follow-up visit on August 20, 2023, revealed that the patient's partner was pregnant.

[0076] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition with kidney-tonifying and essence-replenishing functions, characterized in that, The ingredients include the following parts by weight: 8-22 parts deer antler slices, 5-15 parts prepared aconite root, 8-23 parts epimedium, 5-15 parts morinda root, 5-15 parts cistanche, 8-22 parts prepared rehmannia root, 8-22 parts tribulus terrestris, 5-15 parts turtle shell, 8-22 parts tortoise shell, 5-15 parts angelica root, 8-22 parts wolfberry fruit, 3-9 parts clove, 15-45 parts astragalus root, 5-15 parts polygonatum rhizome, and 3-7 parts raw ginseng.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients include the following parts by weight: 10-20 parts deer antler slices, 8-12 parts prepared aconite root slices, 10-20 parts epimedium, 8-12 parts morinda root, 8-12 parts cistanche, 10-20 parts prepared rehmannia root, 10-20 parts tribulus terrestris, 8-12 parts turtle shell, 10-20 parts tortoise shell, 8-12 parts angelica root, 10-20 parts wolfberry fruit, 4-7 parts clove, 20-40 parts astragalus root, 8-12 parts polygonatum rhizome, and 4-6 parts raw ginseng.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients include the following parts by weight: 15 parts deer antler slices, 10 parts prepared aconite root slices, 15 parts epimedium, 10 parts morinda root, 10 parts cistanche, 15 parts prepared rehmannia root, 15 parts tribulus terrestris, 10 parts turtle shell, 15 parts tortoise shell, 10 parts angelica root, 15 parts wolfberry, 5 parts clove, 30 parts astragalus root, 10 parts polygonatum rhizome, and 5 parts sun-dried ginseng.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, It also includes at least two of the following ingredients by weight: 10-30 parts of roasted hawthorn, 8-22 parts of Shenqu (a type of fermented medicinal herb), 5-15 parts of malt, 5-15 parts of Epimedium, 5-15 parts of leek seeds, 8-22 parts of Taxillus chinensis, and 5-15 parts of Eucommia ulmoides.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, Includes the following steps: The raw materials described in claims 1 to 4 are decocted with water, and the decoction is separated to obtain a traditional Chinese medicine composition.

6. The preparation method according to claim 5, characterized in that, The mass ratio of the raw materials to water is 1:2 to 1:

3.

7. The preparation method according to claim 5, characterized in that, The cooking process ends when the total volume of the ingredients and water is reduced to half.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 5 to 7 in the preparation of a medicament for the prevention and / or treatment of oligospermia and / or asthenospermia.

9. The application according to claim 8, characterized in that, The oligospermia and / or asthenospermia include kidney qi deficiency syndrome, kidney essence deficiency syndrome, or kidney yang deficiency syndrome.

10. The application according to claim 8, characterized in that, The drug includes at least one of the following oral preparations: decoction, pill, drop pill, capsule, granule, tablet and oral liquid.

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