Traditional Chinese medicine composition for treating insufficiency of kidney yang and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating insufficiency of kidney yang and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 20 to 35 parts of rhizoma polygonati extract, 20 to 35 parts of semen astragali complanati, 20 to 35 parts of herba epimedii, 10 to 15 parts of rhizoma drynariae, 10 to 15 parts of fructus rubi, 10 to 15 parts of herba verbenae, 5 to 15 parts of rhizoma polygonati, 5 to 15 parts of cortex eucommiae and 5 to 15 parts of fructus psoraleae. Through scientific compatibility and an optimized preparation process, the curative effect of the traditional Chinese medicine composition in the aspect of treating kidney-yang deficiency is remarkably improved. Experimental results show that the traditional Chinese medicine composition can obviously improve the kidney-yang deficiency symptom, increase the sperm quantity and activity, reduce the sperm malformation rate and improve the sexual organ weight and the female mouse pregnancy rate. In addition, the traditional Chinese medicine composition can be used for preparing traditional Chinese medicine preparations of various dosage forms, and has wide application prospects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly to a traditional Chinese medicine composition for treating insufficient kidney yang and a preparation method thereof. Background Art

[0002] Insufficient kidney yang is a common disease in traditional Chinese medicine, mainly manifested as symptoms such as soreness and weakness of the waist and knees, fear of cold and cold limbs, sexual function decline, reduction in sperm count or insufficient motility, etc. Modern medicine believes that insufficient kidney yang is closely related to factors such as hypothalamic-pituitary-gonadal axis dysfunction, decreased antioxidant capacity, and microcirculation disorders. At present, Western medicine mostly uses hormone replacement therapy to treat insufficient kidney yang, but long-term use may lead to endocrine disorders and other side effects. Therefore, developing a safe and effective traditional Chinese medicine compound preparation has important clinical significance.

[0003] Traditional Chinese medicine has accumulated rich experience in treating insufficient kidney yang. For example, Yougui Pills in Jingyue Quanshu and Wuzi Yanzong Pills in Taiping Huimin Hejiju Fang all take warming the kidney yang and replenishing essence and marrow as the main treatment methods. However, existing traditional Chinese medicine compounds have problems such as unstable curative effects and unclear action mechanisms.

[0004] In summary, developing a traditional Chinese medicine composition based on traditional Chinese medicine theory and combined with modern extraction technology, and improving the curative effect of treating insufficient kidney yang through scientific compatibility and optimized processes, has important clinical value and social significance. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating insufficient kidney yang and a preparation method thereof to solve the problems existing in the above-mentioned prior art. The traditional Chinese medicine composition provided by the present invention can significantly improve the symptoms of insufficient kidney yang through scientific compatibility.

[0006] To achieve the above purpose, the present invention provides the following solutions:

[0007] The present invention provides a traditional Chinese medicine composition for treating insufficient kidney yang, which includes the following components in parts by weight: 20-35 parts of polygonatum sibiricum extract, 20-35 parts of semen astragali complanati, 20-35 parts of epimedium brevicornum, 10-15 parts of drynaria rhizome, 10-15 parts of rubus idaeus, 10-15 parts of verbena officinalis, 5-15 parts of polygonatum sibiricum, 5-15 parts of eucommia ulmoides, and 5-15 parts of psoralea corylifolia.

[0008] Further, it includes the following components in parts by weight: 30 parts of polygonatum sibiricum extract, 25 parts of semen astragali complanati, 25 parts of epimedium brevicornum, 10 parts of drynaria rhizome, 13 parts of rubus idaeus, 11 parts of verbena officinalis, 8 parts of polygonatum sibiricum, 8 parts of eucommia ulmoides, and 7 parts of psoralea corylifolia.

[0009] Further, the preparation method of the polygonatum extract comprises the following steps: pulverize the polygonatum medicinal material, sieve it through a 40-mesh sieve, add a methanol solution, centrifuge and discard the supernatant, extract three times, elute and recover to obtain the polygonatum extract.

[0010] Further, the mass fraction of the methanol solution is 85%, and the addition amount of the methanol solution is 6 times that of the polygonatum medicinal material by mass ratio; the centrifugation is carried out at 3000 rpm for 8 minutes.

[0011] Further, the elution and recovery are carried out through a macroporous resin bed, and then eluted with a methanol solution with a mass fraction of 90%. By mass ratio, the elution volume of the methanol solution is 6 times that of the eluted medicinal material.

[0012] Further, the relative density of the recovery is 1.3.

[0013] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a traditional Chinese medicine preparation for treating kidney-yang deficiency.

[0014] The present invention also provides a traditional Chinese medicine preparation for treating kidney-yang deficiency, and the raw materials include the above-mentioned traditional Chinese medicine composition.

[0015] Further, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0016] Further, the dosage form of the traditional Chinese medicine preparation is decoction, pill, capsule, tablet, powder or granule.

[0017] The present invention discloses the following technical effects:

[0018] The traditional Chinese medicine composition provided by the present invention significantly improves the symptoms of kidney-yang deficiency through scientific compatibility. Among them, epimedium and semen astragali complanati are the monarch drugs, which have the effects of warming the kidney-yang and replenishing essence and marrow; polygonatum extract and polygonatum are the ministerial drugs, nourishing yin and tonifying the kidney, and assisting the monarch drugs to enhance the curative effect; drynaria rhizome, fructus rubi and verbena officinalis are the adjuvant drugs, promoting blood circulation to remove stasis and astringing sperm to reduce urination, further improving the symptoms of kidney-yang deficiency; eucommia ulmoides and psoralea corylifolia are the guiding drugs, guiding the drugs to the meridian and enhancing the overall curative effect. The experimental results show that this composition can significantly increase the swimming survival time and spontaneous activity ability of the kidney-yang deficiency model animals, increase the weight of the sexual organs of castrated rats, increase the sperm quantity and motility, reduce the sperm malformation rate, and significantly increase the pregnancy rate and the number of fetuses of female rats. In addition, the preparation process of this composition is simple, suitable for industrial production, and can be made into various dosage forms to meet the medication needs of different patients. Detailed Embodiments

[0019] Now, various exemplary embodiments of the present invention will be described in detail. This detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, characteristics and implementation schemes of the present invention.

[0020] It should be understood that the terms used in the present invention are only for describing particular embodiments and are not intended to limit the present invention. Additionally, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.

[0021] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0022] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific embodiments of the present invention specification, which are obvious to those skilled in the art. Other embodiments obtained from the present invention specification are obvious to those skilled in the art. The present invention specification and examples are merely exemplary.

[0023] Regarding "comprising", "including", "having", "containing", etc. used herein, they are all open-ended terms, meaning including but not limited to.

[0024] Example 1

[0025] (1) Pretreatment

[0026] Preparation of polygonatum sibiricum extract: The polygonatum sibiricum medicinal materials are crushed and passed through a 40-mesh sieve, and a methanol solution with a mass fraction of 85% is added. The addition amount of the methanol solution is 6 times that of the polygonatum sibiricum medicinal materials by volume ratio. Centrifuge at 3000 rpm for 8 minutes, discard the supernatant, extract 3 times, pass through a macroporous resin bed, and elute with a methanol solution with a mass fraction of 90%. By volume ratio, the elution volume of the methanol solution is 6 times that of the eluted medicinal materials, and the recovered relative density is 1.3 to obtain a dry powdered polygonatum sibiricum extract.

[0027] Raw materials: 30 g of polygonatum sibiricum extract, 25 g of semen astragali complanati, 25 g of epimedium brevicornum, 10 g of drynaria rhizome, 13 g of rubus idaeus, 11 parts of verbena officinalis, 8 g of polygonatum sibiricum, 8 g of eucommia ulmoides, and 7 g of psoralea corylifolia.

[0028] All medicinal materials are identified visually without error, free of impurities, foreign matters, and non-medicinal parts. Before being put into production, Chinese medicinal materials are subjected to cleaning treatment. For those that need to be processed, they are processed according to the methods specified in Part I of the Chinese Pharmacopoeia 2020 Edition.

[0029] (2) Extraction, concentration, and paste preparation

[0030] Accurately weigh 25 g of Semen Astragali Complanati, 25 g of Herba Epimedii, 10 g of Rhizoma Drynariae, 13 g of Fructus Rubi, and 11 g of Herba Verbenae. Decoct them three times with water, with the water addition amounts being 8 times, 8 times, and 6 times respectively. The extraction times are 1.5 hours for the first time, 1 hour for the second time, and 0.5 hour for the third time. Combine the decoction liquids, filter, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.25 - 1.30 (60 °C) for standby.

[0031] (3) Grinding to obtain fine powder

[0032] Accurately weigh 8 g of Rhizoma Polygonati, 8 g of Cortex Eucommiae, and 7 g of Fructus Psoraleae, put them into a mixing trough, mix evenly, grind, and sieve to obtain fine powder for standby.

[0033] (4) Mixing and drying

[0034] Put the clear paste obtained in step (2), the fine powder obtained in step (3), and 30 g of the extract of Rhizoma Polygonati in step (1) into a trough-type mixer, mix evenly, put it into a vacuum drying oven, dry at 80 °C until completely dry, control the moisture content at 4.0 - 9.0%, grind into fine powder, and sieve.

[0035] (5) Granulation and drying

[0036] Add cross-linked polyvinylpyrrolidone accounting for 1% of the weight of the dried paste powder after grinding into a trough-type mixer, stir for 10 minutes, sieve and granulate, place it in a drying oven, dry at 80 °C, control the moisture content at 7%, and sieve for sizing. [[ID=2,6]]

[0037] (6) Total mixing

[0038] The materials are sealed and stored in a clean container, indicating the name of the product, batch number, quantity, date, etc., and sent to the transfer station. For in-process products, conduct inspection: appearance, identification, moisture content, content. Only after passing the inspection can the tableting operation be carried out.

[0039] (7) Tableting

[0040] The average tablet weight is 0.38 g - 0.39 g, and the weight variation is 0.38 g - 0.40 g. During the tableting process, the operator weighs the tablet weight every 15 minutes, detects the tablet weight range every 30 minutes, and calculates the weight variation; checks the appearance every 30 minutes. Before starting the machine or after stopping for more than 30 minutes and then restarting, check the friability, hardness, and disintegration time limit. Among them, the disintegration time limit ≤ 50 minutes, the friability ≤ 1%, and the hardness should ≥ 2.5 kg. Obtain the Shengjing tablets for standby.

[0041] Example 2

[0042] (1) Pretreatment

[0043] Preparation of polygonatum sibiricum extract: The polygonatum sibiricum medicinal materials were crushed and passed through a 40-mesh sieve, and then added with a methanol solution with a mass fraction of 85%. The addition amount of the methanol solution was 6 times that of the polygonatum sibiricum medicinal materials by volume. After centrifugation at 3000 rpm for 8 minutes, the supernatant was discarded, and the extraction was carried out 3 times. After passing through a macroporous resin bed, it was eluted with a methanol solution with a mass fraction of 90%. By volume, the elution volume of the methanol solution was 6 times that of the eluted medicinal materials. The recovered relative density was 1.3, and a dry powder-like polygonatum sibiricum extract was obtained.

[0044] Raw materials: 20 g of polygonatum sibiricum extract, 20 g of astragalus complanatus, 20 g of epimedium brevicornu, 10 g of drynaria fortunei, 10 g of rubus idaeus, 10 parts of verbena officinalis, 5 g of polygonatum sibiricum, 5 g of eucommia ulmoides, and 5 g of psoralea corylifolia.

[0045] All the medicinal materials were identified by appearance without error, without impurities, foreign matters, and non-medicinal parts. The Chinese medicinal materials were subjected to cleaning treatment before feeding. For those that need to be processed, they were processed according to the methods specified in Part I of the Chinese Pharmacopoeia 2020 Edition.

[0046] (2) Extraction, concentration, and paste collection

[0047] Accurately weigh 20 g of astragalus complanatus, 20 g of epimedium brevicornu, 10 g of drynaria fortunei, 10 g of rubus idaeus, and 10 g of verbena officinalis, and decoct them three times with water. The water addition amounts are 8 times, 8 times, and 6 times in sequence. The extraction times are 1.5 hours for the first time, 1 hour for the second time, and 0.5 hour for the third time. The decoction liquids were combined, filtered, and the filtrate was concentrated under reduced pressure to a clear paste with a relative density of 1.25 - 1.30 (60 °C) for standby.

[0048] (3) Crushing to obtain fine powder

[0049] Accurately weigh 5 g of polygonatum sibiricum, 5 g of eucommia ulmoides, and 5 g of psoralea corylifolia medicinal materials, place them in a mixing trough, mix them evenly, crush them, and pass them through a sieve to obtain fine powder for standby.

[0050] (4) Mixing and drying

[0051] Put the clear paste obtained in step (2), the fine powder obtained in step (3), and 20 g of the polygonatum sibiricum extract in step (1) into a trough-type mixer, mix them evenly, place them in a vacuum drying oven, and dry them at 80 °C until completely dry. The moisture content was controlled at 4.0 - 9.0%, crushed into fine powder, and passed through a sieve.

[0052] (5) Granulation and drying

[0053] Add cross-linked polyvinylpyrrolidone accounting for 1% of the weight of the dried paste powder after crushing into a trough-type mixer, stir for 10 minutes, pass through a sieve for granulation, place it in a drying oven, dry it at 80 °C, control the moisture content at 7%, and pass through a sieve for sizing.

[0054] (6) Total mixing

[0055] The materials are stored in clean containers and sealed, indicating the name of the product, batch number, quantity, date, etc., and delivered to the transfer station. For the intermediate products, the following inspections are required: appearance, identification, moisture content, and content. Only after passing the inspection can the tableting operation be carried out.

[0056] (7) Tableting

[0057] The average tablet weight is 0.38 g - 0.39 g, and the weight variation is 0.38 g - 0.40 g. During the tableting process, the operator weighs the tablet weight every 15 minutes, detects the tablet weight range every 30 minutes, and calculates the weight variation; checks the appearance every 30 minutes. Before starting the machine or after stopping for more than 30 minutes and then restarting, check the friability, hardness, and disintegration time limit. Among them, the disintegration time limit ≤ 50 minutes, the friability ≤ 1%, and the hardness should ≥ 2.5 kg. The Shengjing tablets are obtained and reserved for use.

[0058] Example 3

[0059] (1) Pretreatment

[0060] Preparation of polygonatum extract: The polygonatum medicinal materials are crushed and passed through a 40-mesh sieve, and a methanol solution with a mass fraction of 85% is added. The addition amount of the methanol solution is 6 times the volume of the polygonatum medicinal materials. Centrifuge at 3000 rpm for 8 minutes, discard the supernatant, extract 3 times, pass through a macroporous resin bed, and elute with a methanol solution with a mass fraction of 90%. By volume, the elution volume of the methanol solution is 6 times the volume of the eluted medicinal materials. The relative density of the recovered solution is 1.3, and the dry powdered polygonatum extract is obtained.

[0061] Raw materials: 35 g of polygonatum extract, 35 g of semen astragali complanati, 35 g of epimedium, 15 g of drynaria rhizome, 15 g of raspberry, 15 parts of verbena officinalis, 15 g of polygonatum, 15 g of eucommia ulmoides, and 15 g of psoralea corylifolia.

[0062] All the medicinal materials are visually inspected and found to be free of impurities, foreign objects, and non-medicinal parts. The Chinese medicinal materials are subjected to cleaning treatment before being fed. For those that need to be processed according to traditional Chinese medicine processing methods, they are processed according to the methods specified in Part I of the Chinese Pharmacopoeia 2020 Edition.

[0063] (2) Extraction, concentration, and obtaining the extract paste

[0064] Accurately weigh 25 g of semen astragali complanati, 25 g of epimedium, 10 g of drynaria rhizome, 13 g of raspberry, and 11 g of verbena officinalis, and decoct with water three times. The amounts of added water are 8 times, 8 times, and 6 times respectively. The extraction times are 1.5 hours for the first time, 1 hour for the second time, and 0.5 hour for the third time. Combine the decoction liquids, filter, and concentrate the filtrate under reduced pressure to obtain a clear paste with a relative density of 1.25 - 1.30 (60 °C) for standby.

[0065] (3) Crushing to obtain fine powder

[0066] Accurately weigh 8g of Polygonatum sibiricum, 8g of Eucommia ulmoides and 7g of Psoralea corylifolia, place them in a mixing tank, mix them evenly, crush them, sieve them to obtain fine powder for later use.

[0067] (4) Mixing and drying

[0068] The paste obtained in step (2), the fine powder obtained in step (3) and 35 g of the polygonatum extract in step (1) are placed in a trough mixer, mixed evenly, placed in a vacuum drying oven, dried at 80°C until completely dry, with the moisture content controlled at 7%, crushed into fine powder, and sieved.

[0069] (5) Granulation and drying

[0070] The crushed dry paste powder and 1% cross-linked polyvinylpyrrolidone by weight of the dry paste powder are added into a trough mixer, stirred for 10 minutes, sieved and granulated, placed in a drying oven, dried at 80°C, the moisture content of which is controlled at 4.0-9.0%, and sieved for granulation.

[0071] (6) Mixing

[0072] The materials should be sealed in clean containers and marked with product name, batch number, quantity, date, etc., and then delivered to the transfer station. The intermediate products should be inspected for properties, identification, moisture content, and content. Only those that meet the requirements can be tableted.

[0073] (7) Tablet pressing

[0074] The average tablet weight is 0.38g-0.39g, with a weight variance of 0.38g-0.40g. During the tableting process, the operator should weigh the tablets every 15 minutes, check the tablet weight range every 30 minutes, and calculate the weight variance. The appearance should also be inspected every 30 minutes. Before starting the machine or after stopping for more than 30 minutes and then restarting it, check the friability, hardness, and disintegration time. The disintegration time should be ≤ 50 minutes, the friability ≤ 1%, and the hardness ≥ 2.5kg. Prepare the spermatogenic tablets and set aside.

[0075] Comparative Example 1

[0076] The same as Example 1, except that: this comparative example omits the "pretreatment" step in Example 1, and replaces the "Polygonatum sibiricum extract" in Example 1 with "Polygonatum sibiricum medicinal material crushed and then passed through a 40-mesh sieve."

[0077] Comparative Example 2

[0078] The same as Example 1, except that the raw materials of this comparative example are: 40g of polygonatum extract, 37g of complanatus, 18g of epimedium, 17g of drynaria, 8g of raspberry, 17 parts of verbena, 4g of polygonatum, 16g of eucommia and 4g of psoralea corylifolia.

[0079] Comparative Example 3

[0080] Same as Example 1, with the only difference being that in this comparative example, semen astragali complanati is replaced by ginkgo leaves.

[0081] Effect verification

[0082] 1. Materials

[0083] 1.1 Test drugs

[0084] The spermatogenic tablets prepared in Examples 1-3 and Comparative Examples 1-3; Wuzi Yanzong Pills were provided by Guangzhou Jiahe Pharmaceutical Factory, batch number 2000401; Hydrocortisone Injection (Hydrocortisone) was provided by Shanghai No. 2 Pharmaceutical Factory, batch number 961211.

[0085] 1.2 Animals

[0086] Wistar rats (rats) weighing 100 ± 10 g, Kunming mice (mice) weighing 19 - 28 g (both male and female), both were provided by the Experimental Animal Research Institute of the Third Military Medical University of the Chinese People's Liberation Army.

[0087] 2. Methods and results

[0088] 2.1 Study on the kidney-tonifying effect on animals with kidney-yang deficiency induced by injecting hydrocortisone

[0089] Take 120 mice and randomly divide them into six groups: normal control group (gavage with 20 ml / kg of distilled water (PO)); kidney-yang deficiency model group (intramuscular injection of 25 mg / kg of hydrocortisone); high, medium, and low dose groups of the spermatogenic tablets prepared in Example 1 (spermatogenic tablets 2.4 g / kg,

[0090] 1.2 g / kg, 0.6 g / kg PO) and Wuzi Yanzong Pills group (Wuzi Yanzong Pills 1.2 g / kg PO). All six groups were intramuscularly injected with 25 mg / kg of hydrocortisone once a day for 4 consecutive days.

[0091] 1 hour after the last dose, weigh the mice in each treatment group. After measuring the anal temperature of 10 mice (a total of 60 mice) respectively, put each mouse into a small animal swimming pool with a water temperature of 20 °C, observe and record the data that the mouse's head sinks and cannot float out of the water within 5 s, which is the swimming survival time of the mouse (judge the effect of each treatment group on the swimming survival time of the mouse according to the length of the swimming time), and judge the anti-fatigue effect of each treatment group on the mouse according to the length of the swimming time; in addition, take 10 mice from each group (a total of 60 mice) and put each mouse into a "dark box" respectively, observe the number of spontaneous activities of the mouse within 10 min to judge the spontaneous activity status of the mouse, and then remove the left eyeball of each mouse respectively, take blood to check the blood WBC (white blood cells), RBC (red blood cells) and count them.

[0092] The results showed that the mice in the kidney-yang deficiency model group showed weight loss, shortened swimming survival time, decreased spontaneous activity, and decreased WBC and RBC, indicating the establishment of the kidney-yang deficiency model. The mice in the spermatogenesis tablets group and the Wuzi Yanzong Pills group prepared in Example 1 were examined for the above indicators, and compared with the normal control group, there were varying degrees of improvement, and the improvement effect of the low-dose group in the spermatogenesis tablets group prepared in Example 1 was comparable to that of the Wuzi Yanzong Pills group.

[0093] 2.2 Effects on the weights of sexual organs of castrated rats (kidney deficiency)

[0094] The rats were lightly anesthetized with ether, the scrotal skin was disinfected, both testes were removed, the skin was sutured, and castrated kidney-deficiency model rats were established. After 15 days of feeding, 60 rats were taken, randomly grouped and given drugs PO once a day for 15 consecutive days. Among them, the rats in the model group were given 20 mg / kg of normal saline PO; the drug-administered groups were the spermatogenesis tablets dose groups (1.2 g / kg of spermatogenesis tablets PO), and the Wuzi Yanzong Pills group (1.2 g / kg of Wuzi Yanzong Pills PO) respectively prepared in Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3. After 24 hours of the last dose in each treatment group, the body weights were weighed, and the prepuce glands, seminal vesicles + prostate glands of the rats in each treatment group were removed by laparotomy, weighed respectively and the data were statistically analyzed.

[0095] The results showed that the weights of the prepuce glands, seminal vesicles + prostate glands of the rats in the model group were significantly reduced, indicating the establishment of the castrated rat model. The spermatogenesis tablets dose groups and the Wuzi Yanzong Pills group prepared in Example 1 could increase the weights of the sexual organs (prepuce glands, seminal vesicles + prostate glands) of kidney-deficiency syndrome compared with the model group. Among them, the effect of increasing the weights of the sexual organs of the spermatogenesis tablets dose groups prepared in Example 1 was comparable to that of the Wuzi Yanzong Pills group. The effects of increasing the weights of the sexual organs of the spermatogenesis tablets dose groups in Comparative Examples 1-3 were significantly lower than those of the spermatogenesis tablets dose groups and the Wuzi Yanzong Pills group prepared in Example 1.

[0096] 2.3 Effects on sperm and sexual organs of young male mice

[0097] Taking the number of sperm in the epididymis of male mice, sperm motility, the pregnancy rate of female mice and the number of fetuses as observation indexes, 60 male mice were randomly divided into six groups: the kidney-yang deficiency model group (intramuscular injection of hydrocortisone at 25 mg / kg), the normal control group (oral administration of distilled water at 20 ml / kg), the high, medium and low dose groups of the spermatogenic tablets prepared in Example 2 (oral administration of spermatogenic tablets at 2.4 g / kg, 1.2 g / kg, 0.6 g / kg), and the Wuzi Yanzong Pills group (oral administration of Wuzi Yanzong Pills at 1.2 g / kg). The male mice in each treatment group were caged with normal untreated female mice at a ratio of 1:2 for 8 days. The male and female mice were separated and fed for 10 days. Then the male mice were dissected to take the head and tail of the epididymis, rinsed and shaken well with 1 mL of normal saline (NS), and one drop was dripped into the erythrocyte counting chamber to observe and record the number of sperm (ten thousand / ml) and the motility rate. In addition, the uterus of each group of female mice was dissected to observe and record the number of fetuses of female mice and calculate the pregnancy rate of female mice.

[0098] The results showed that the high, medium and low dose groups of the spermatogenic tablets prepared in Example 2 and the Wuzi Yanzong Pills group, compared with the normal control group, could all increase the number of sperm in young male mice, enhance sperm motility, improve the pregnancy rate of female mice and increase the number of fetuses. Among them, the effect of the Wuzi Yanzong Pills group was equivalent to that of the medium dose group of the spermatogenic tablets prepared in Example 2. It was shown that the spermatogenic tablets provided by the present invention had a promoting effect on the fertility of young male mice.

[0099] 2.4 Effects on sperm and sex organs of young male rats

[0100] Taking the increase in the number of sperm, the enhancement of sperm motility and the weight gain of sex organs as indexes to observe the effects on sexual maturity. 50 young male rats one month after weaning were randomly divided into 5 groups (the normal control group (oral administration of distilled water at 20 ml / kg), the high, medium and low dose groups of the spermatogenic tablets prepared in Example 3 (oral administration of spermatogenic tablets at 2.4 g / kg, 1.2 g / kg, 0.6 g / kg), and the Wuzi Yanzong Pills group (oral administration of Wuzi Yanzong Pills at 1.2 g / kg). The drugs were administered once a day for 15 consecutive days. 24 hours after the last administration, the rats in each group were sacrificed respectively, the abdomen was opened, and the testes, epididymides, seminal vesicles + prostate were separated and weighed. Immediately, the head and tail of the epididymis were rinsed with 1 mL of normal saline to wash the sperm in the cavity, the liquid was mixed evenly, and one drop was placed on a glass slide and observed under a low-power optical microscope for sperm morphology. A small amount of sperm suspension was aspirated and placed in a hemocytometer, and the number of motile sperm in the white blood cell counting area of the counting plate was counted under a biological microscope to calculate the motile sperm rate and the abnormal sperm rate.

[0101] The results showed that the high, medium and low dose groups of the spermatogenic tablets prepared in Example 3 and the Wuzi Yanzong Pills group, compared with the normal control group, could significantly increase the number of sperm and sperm motility and reduce the abnormal sperm. Among them, the medium dose group of the spermatogenic tablets prepared in Example 3 and the Wuzi Yanzong Pills group had equivalent effects in promoting sperm motility.

[0102] 2.5 Effects on Sperm and Sexual Organs of Young Male Rats

[0103] The effects on sexual maturity were observed with increased sperm count, enhanced sperm motility, and increased weight of sexual organs as indicators. Sixty young male rats at one month after weaning were randomly divided into 6 groups: normal control group (20 ml / kg of distilled water, PO), spermatogenic tablets dose group prepared in Example 1 (1.2 g / kg of spermatogenic tablets, PO), spermatogenic tablets dose group prepared in Comparative Example 1 (1.2 g / kg of spermatogenic tablets, PO), spermatogenic tablets dose group prepared in Comparative Example 2 (1.2 g / kg of spermatogenic tablets, PO), spermatogenic tablets dose group prepared in Comparative Example 3 (1.2 g / kg of spermatogenic tablets, PO), and Wuzi Yanzong Pills group (1.2 g / kg of Wuzi Yanzong Pills, PO). They were administered once a day for 15 consecutive days. 24 hours after the last administration, the rats in each treatment group were sacrificed respectively, the abdomen was opened, and the testes, epididymides, seminal vesicles + prostate were separated and weighed. Immediately, the head and tail of the epididymis were rinsed with 1 mL of normal saline to wash the sperm in the cavity, the liquid was mixed evenly, and a drop was taken and placed under a low-power light microscope on a glass slide to observe the sperm morphology. A small amount of sperm suspension was aspirated and placed in a hemocytometer, and the number of motile sperm in the white blood cell counting area of the counting plate was counted under a biological microscope, and the motility rate and abnormal sperm rate were calculated.

[0104] The results showed that, compared with Comparative Examples 1-3, the spermatogenic tablets dose group prepared in Example 1 and the Wuzi Yanzong Pills group could significantly increase the sperm count and sperm motility rate, and reduce the abnormal sperm rate. When comparing the effects of the motility rate and abnormal sperm rate of the spermatogenic tablets dose group prepared in Example 1 and the Wuzi Yanzong Pills group, the effects were equivalent.

[0105] In summary, the purpose of this experiment was to observe the effects of the spermatogenic tablets prepared in Examples 1-3 and Comparative Examples 1-3 on tonifying the kidney and replenishing essence, nourishing yin and strengthening yang in animals. The experimental results showed that the spermatogenic tablets prepared in Examples 1-3 could significantly improve the symptoms of experimental kidney yang deficiency in animals, significantly increase the weight of sexual organs of castrated male mice, significantly increase the sperm count and enhance the sperm motility of young rats and mice, reduce the sperm abnormality rate, and significantly increase the pregnancy rate and the number of fetuses of female rats.

[0106] The above-described embodiments are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention should fall within the protection scope determined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insufficient kidney yang, characterized in that, The invention comprises the following components by weight: 20-35 parts of polygonatum sibiricum extract, 20-35 parts of complanatus seeds, 20-35 parts of epimedium, 10-15 parts of drynaria rhizome, 10-15 parts of raspberry, 10-15 parts of verbena, 5-15 parts of polygonatum sibiricum, 5-15 parts of eucommia bark and 5-15 parts of psoralea corylifolia.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components in parts by weight: 30 parts of polygonatum sibiricum extract, 25 parts of complanatus seeds, 25 parts of epimedium, 10 parts of drynaria rhizome, 13 parts of raspberry, 11 parts of verbena, 8 parts of polygonatum sibiricum, 8 parts of eucommia bark and 7 parts of psoralea corylifolia.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The preparation method of the polygonatum sibiricum extract comprises the following steps: crushing the polygonatum sibiricum medicinal material and then passing it through a 40-mesh sieve, adding a methanol solution, centrifuging and discarding the supernatant, extracting three times, eluting and recovering, and obtaining the polygonatum sibiricum extract.

4. The traditional Chinese medicine composition according to claim 3, wherein The mass fraction of the methanol solution is 85%, and the amount of the methanol solution added is 6 times that of the polygonatum sibiricum medicinal material in terms of mass ratio; the centrifugation is performed at 3000 rpm for 8 minutes.

5. The traditional Chinese medicine composition according to claim 3, wherein, The elution recovery is performed by eluting with a methanol solution having a mass fraction of 90% after passing through a macroporous resin bed. Calculated by mass ratio, the elution volume of the methanol solution is 6 times that of the eluted medicinal material.

6. The traditional Chinese medicine composition according to claim 3, wherein The recovered relative density was 1.

3.

7. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in preparing a traditional Chinese medicine preparation for treating kidney yang deficiency.

8. A traditional Chinese medicine preparation for treating insufficient kidney yang, characterized in that, The raw materials include the Chinese medicine composition according to any one of claims 1 to 6.

9. The traditional Chinese medicine preparation according to claim 8, wherein, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

10. The traditional Chinese medicine preparation according to claim 8, wherein The dosage form of the Chinese medicine preparation is decoction, pill, capsule, tablet, powder or granule.