A traditional Chinese medicine composition for qi and blood deficiency, swelling and pain relief and a preparation method thereof

Abstract

The application discloses a traditional Chinese medicine composition for qi-blood deficiency, swelling and pain relieving and a preparation method thereof, which is prepared from honeysuckle stem, radix sargentiae, liquorice, red ginseng, pilose antler, prepared rehmannia root, dandelion, cortex moutan, red peony root, Chinese evodia fruit and prepared rhizoma corydalis according to certain proportions; compared with the prior art, the application has more reasonable prescription, and has remarkable curative effect on leukorrhagia and abdominal pain caused by menstrual irregularity, abdominal pain during menstruation, pelvic inflammation, adnexitis and endometritis and the like caused by qi-blood deficiency; the application has reasonable prescription, remarkable curative effect and no toxic and side effects.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating qi and blood deficiency, reducing swelling and relieving pain, and its preparation method. Its characteristics include its use for menstrual disorders and dysmenorrhea caused by qi and blood deficiency, as well as leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, endometritis, etc. It belongs to the field of pharmaceutical technology. Technical Background

[0002] Prior art: 1. Chinese Patent Gazette published a patent application entitled "Drug for Treating Chronic Pelvic Inflammatory Disease and Preparation Method Thereof" on February 10, 2010, with publication number CN101642492A. The weight ratio of the raw materials constituting this invention is: Lonicera japonica 24g, Sargentodoxa cuneata 24g, Paeonia suffruticosa 8g, Rheum palmatum 5g, Corydalis yanhusuo 7g, Isatis indigotica 8g, Taraxacum mongolicum 7g, Paeonia lactiflora 7g, Melia toosendan 7g, Glycyrrhiza uralensis 3g. 2. Chinese Patent Gazette published a patent entitled "One The patent application CN105796667A, entitled "A Traditional Chinese Medicine Composition for Clearing Heat, Cooling Blood, Reducing Swelling and Relieving Pain and Its Preparation Method", specifies the following composition of raw materials: 2702.4g of Lonicera japonica vine, 540.5g of Sargentodoxa cuneata vine, 270.2g of Glycyrrhiza uralensis, 810.7g of Isatis indigotica leaf, 810.7g of Taraxacum mongolicum, 810.7g of Paeonia suffruticosa bark, 810.7g of Paeonia lactiflora, 810.7g of Melia toosendan fruit, 810.7g of processed Corydalis yanhusuo, and 2702.4g of processed Rheum palmatum. 3. On July 22, 2009, the Chinese Patent Gazette published a patent application entitled "A Traditional Chinese Medicine Composition for Treating Gynecological Diseases and Its Preparation Method," with publication number CN101485742A. The proportions of the raw materials in this invention are: 10 parts of Lonicera japonica vine, 10 parts of Sargentodoxa cuneata vine, 3 parts of Carthamus tinctorius, 3 parts of Sophora flavescens, 3 parts of Isatis indigotica leaf, 3 parts of Taraxacum mongolicum, 3 parts of Paeonia suffruticosa bark, 3 parts of Paeonia lactiflora, 3 parts of processed Corydalis yanhusuo, 2 parts of processed Rheum palmatum, and 1 part of Glycyrrhiza uralensis. 4. "Fule Chongji" under item WS3-B-1541-93 in Volume VIII of the Ministry of Health's Drug Standard "Traditional Chinese Medicine Compound Preparations" is a pure traditional Chinese medicine preparation. After many years of clinical application, this medicine has achieved certain therapeutic effects in treating pelvic inflammatory disease, adnexitis, and endometritis. The applicant, through years of clinical and pharmacodynamic research, found that the existing technologies mentioned in 1-4 primarily treat chronic pelvic inflammatory disease, with unsatisfactory efficacy, particularly for menstrual disorders and dysmenorrhea caused by qi and blood deficiency, as well as leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, and endometritis. Through extensive prescription screening and pharmacological research, the inventors further developed the "Fule Granules" prescription. Unexpectedly, by replacing "Daqingye and Dahuang" with "Hongshen, Lurong, and Shudihuang" and adjusting the dosage of the raw materials, the pharmacodynamic effects in treating leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, and endometritis were significantly improved, and the pharmacodynamic effects on menstrual disorders and dysmenorrhea caused by qi and blood deficiency were also significant. We have manufactured tablets, capsules, and granules using conventional processes. Summary of the Invention

[0003] The purpose of this invention is to provide a more effective traditional Chinese medicine composition for treating qi and blood deficiency, reducing swelling and relieving pain, and its preparation method. Its characteristic is that the composition of each raw material in the traditional Chinese medicine composition of this invention is as follows:

[0004]

[0005]

[0006] The preferred composition of each raw material in the traditional Chinese medicine composition of this invention is as follows:

[0007]

[0008] The traditional Chinese medicine composition of this invention can be prepared into tablets, capsules, and granules. The specific preparation methods are as follows:

[0009] 1. Preparation method of the traditional Chinese medicine composition tablets of the present invention:

[0010] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate excipients, mixed well, granulated, dried, and sized. An appropriate amount of lubricant is added, mixed well, and compressed into 1000 tablets. These tablets are then coated with a film to obtain the final product.

[0011] 2. Preparation method of the capsule form of the traditional Chinese medicine composition of the present invention:

[0012] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and encapsulated to produce 1000 capsules, thus obtaining the capsule formulation.

[0013] 3. Preparation method of the traditional Chinese medicine composition granules of the present invention:

[0014] The above eleven ingredients are selected from ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and bagged to produce 1000 bags, thus obtaining the granules.

[0015] Beneficial effects of this invention: Through extensive prescription screening and pharmacological research, the inventors conducted secondary development of the "Fule Granules" prescription. An unexpected discovery was made: by replacing *Daqingye* and *Dahuang* with *Hongshen*, *Lurong*, and *Shudihuang*, and adjusting the dosage of the raw materials, the pharmacodynamic effects in treating leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, and endometritis were significantly improved. Furthermore, the pharmacodynamic effects on menstrual disorders and dysmenorrhea caused by qi and blood deficiency were also significant. We have manufactured tablets, capsules, granules, and oral liquids using conventional processes. The intended use of this herbal composition is in the treatment of menstrual disorders and dysmenorrhea caused by qi and blood deficiency, as well as leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, and endometritis.

[0016] Pharmacodynamic studies:

[0017] Compared with the closest prior art, the Chinese medicine composition of this invention has significantly improved the pharmacodynamic effects in treating leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, and endometritis, and has also shown significant pharmacodynamic effects in treating menstrual disorders and menstrual cramps caused by deficiency of both qi and blood.

[0018] The closest prior art comparison document 1: "Fule Granules" under WS3-B-1541-93 of Volume 8 of the Ministry of Health's Drug Administration Standard "Traditional Chinese Medicine Compound Preparations". The raw materials are: 500g of honeysuckle vine, 500g of large blood vine, 50g of licorice, 150g of indigo leaf, 150g of dandelion, 150g of peony bark, 150g of red peony root, 150g of Sichuan pepper, 150g of processed corydalis rhizome, and 100g of processed rhubarb.

[0019] The main pharmacodynamic studies have demonstrated that:

[0020] The weight ratio of each raw material in this invention is: "Honeysuckle vine 2702g, Sargentodoxa cuneata 2702g, Licorice root 270g, Red ginseng 270g, Deer antler 54g, Rehmannia glutinosa 1028g, Dandelion 811g, Moutan bark 811g, Red peony root 811g, Sichuan pepper 811g, Prepared Corydalis rhizome 811g." This is the same as the weight ratio group in prior art document 1: "Honeysuckle vine 500g, Sargentodoxa cuneata 500g." g, Licorice 50g, Isatis leaf 150g, Dandelion 150g, Moutan bark 150g, Red peony root 150g, Sichuan pepper 150g, Corydalis rhizome (processed) 150g, Rhubarb (processed) 100g. And the same weight ratio as prescription 1: "Honeysuckle vine 2702g, Sargentodoxa cuneata 811g, Licorice 270g, Red ginseng 54g, Deer antler 270g, Rehmannia glutinosa 1028g, Dandelion..." The formula consists of: 811g of *Evodia rutaecarpa*, 811g of *Paeonia suffruticosa*, 2702g of *Paeonia lactiflora*, 811g of *Melia azedarach*, and 811g of prepared *Corydalis yanhusuo*. The formula also includes: 2702g of *Lonicera japonica*, 2702g of *Sargentodoxa cuneata*, 811g of licorice root, 811g of red ginseng, 22g of deer antler, 1060g of prepared *Rehmannia glutinosa*, 379g of dandelion, 811g of *Paeonia suffruticosa*, 811g of *Paeonia lactiflora*, and 432g of *Melia azedarach*. Compared to the formula with the same weight ratio as: "Honeysuckle vine 811g, Sargentodoxa cuneata 1028g, Licorice root 270g, Red ginseng 540g, Deer antler 108g, Rehmannia glutinosa 811g, Dandelion 2702g, Moutan bark 2702g, Red peony root 811g, Sichuan pepper 487g, and prepared Corydalis yanhusuo 811g," the pharmacodynamic test results are significantly improved. The main pharmacodynamic tests are as follows:

[0021] (I) Preparation of experimental drugs:

[0022] 1. Raw materials:

[0023] The present invention comprises: 2702g of Lonicera japonica vine, 2702g of Sargentodoxa cuneata, 270g of Glycyrrhiza uralensis, 270g of Panax ginseng, 54g of deer antler, 1028g of Rehmannia glutinosa, 811g of Taraxacum mongolicum, 811g of Paeonia suffruticosa, 811g of Paeonia lactiflora, 811g of Melia toosendan, and 811g of Corydalis yanhusuo (prepared according to the proportion of the present invention: 2702g of Lonicera japonica vine, 2702g of Sargentodoxa cuneata, 270g of Glycyrrhiza uralensis, 270g of Panax ginseng, 54g of deer antler, 1028g of Rehmannia glutinosa, 811g of Taraxacum mongolicum, 811g of Paeonia suffruticosa, 811g of Paeonia lactiflora, 811g of Melia toosendan, and 811g of Corydalis yanhusuo).

[0024] Group A is the weight ratio group of Comparative Document 1: prepared from 2702g of Lonicera japonica vine, 2702g of Sargentodoxa cuneata, 270g of Glycyrrhiza uralensis, 811g of Isatis indigotica leaf, 811g of Taraxacum mongolicum, 811g of Paeonia suffruticosa bark, 811g of Paeonia lactiflora, 811g of Melia toosendan fruit, 811g of Corydalis yanhusuo (processed), and 540g of Rheum palmatum (processed) (according to the weight ratio group of Comparative Document 1: 500g of Lonicera japonica vine, 500g of Sargentodoxa cuneata, 50g of Glycyrrhiza uralensis, 150g of Isatis indigotica leaf, 150g of Taraxacum mongolicum, 150g of Paeonia suffruticosa bark, 150g of Paeonia lactiflora, 150g of Melia toosendan fruit, 150g of Corydalis yanhusuo (processed), and 100g of Rheum palmatum (processed)). Group B The weight ratio of Prescription 1 is as follows: 2702g of Lonicera japonica vine, 811g of Sargentodoxa cuneata, 270g of Glycyrrhiza uralensis, 54g of Panax ginseng, 270g of deer antler, 1028g of Rehmannia glutinosa, 811g of Taraxacum mongolicum, 811g of Paeonia suffruticosa, 2702g of Paeonia lactiflora, 811g of Melia toosendan, and 811g of Corydalis yanhusuo (prepared according to the weight ratio of Prescription 1: 2702g of Lonicera japonica vine, 811g of Sargentodoxa cuneata, 270g of Glycyrrhiza uralensis, 54g of Panax ginseng, 270g of deer antler, 1028g of Rehmannia glutinosa, 811g of Taraxacum mongolicum, 811g of Paeonia suffruticosa, 2702g of Paeonia lactiflora, 811g of Melia toosendan, and 811g of Corydalis yanhusuo). Group C is the weight ratio group of Prescription 2: it is prepared from 2702g of honeysuckle vine, 2702g of large-stem vine, 811g of licorice, 811g of red ginseng, 22g of deer antler, 1060g of prepared rehmannia root, 379g of dandelion, 811g of peony bark, 811g of red peony root, 432g of Sichuan pepper, and 540g of prepared corydalis rhizome (according to the weight ratio group of Prescription 2: 2702g of honeysuckle vine, 2702g of large-stem vine, 811g of licorice, 811g of red ginseng, 22g of deer antler, 1060g of prepared rehmannia root, 379g of dandelion, 811g of peony bark, 811g of red peony root, 432g of Sichuan pepper, and 540g of prepared corydalis rhizome). Group d is the weight ratio group of prescription 3: it is prepared from 811g of honeysuckle vine, 1028g of large-stem vine, 270g of licorice, 540g of red ginseng, 108g of deer antler, 811g of prepared rehmannia root, 2702g of dandelion, 2702g of peony bark, 811g of red peony root, 487g of Sichuan pepper, and 811g of prepared corydalis rhizome (according to the weight ratio group of prescription 3: 811g of honeysuckle vine, 1028g of large-stem vine, 270g of licorice, 540g of red ginseng, 108g of deer antler, 811g of prepared rehmannia root, 2702g of dandelion, 2702g of peony bark, 811g of red peony root, 487g of Sichuan pepper, and 811g of prepared corydalis rhizome).

[0025] 2. The manufacturing methods of Groups b, c, and d of this invention are the same, as detailed below:

[0026] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate excipients, mixed well, granulated, dried, and sized. An appropriate amount of lubricant is added, mixed well, and compressed into 1000 tablets. These tablets are then coated with a film to obtain the final product.

[0027] Preparation method A: The specific details of "Fule Granules" under item WS3-B-1541-93 in Volume VIII of the Ministry of Health's Drug Administration Standard "Traditional Chinese Medicine Compound Preparations" are as follows:

[0028] For the above ten ingredients, rhubarb is crushed into coarse powder. Following the percolation method under the section on fluid extracts and extracts, 60% ethanol is used as the solvent. After soaking for 24 hours, percolation is performed. The percolate is collected, filtered, and concentrated under reduced pressure to a clear extract with a relative density of 1.20–1.22 (45–50℃). The residue is reserved. The remaining nine ingredients, including honeysuckle vine, are decocted twice with water. The first decoction is for 2 hours, and the second decoction is decocted for 1 hour after adding the rhubarb percolation residue. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06–1.08 (85–90℃). The filtrate is combined with the clear extract, mixed evenly, spray-dried into powder, and then granulated with an appropriate amount of excipients. The granules are dried and sized to obtain the final product.

[0029] (II) Pharmacodynamic experimental procedure:

[0030] Experimental objective: To study the anti-inflammatory, analgesic, uterine autonomous activity, and anti-fatigue effects of the present invention group, group a, group b, group c, and group d, and to compare the present invention group with groups a, b, c, and d to observe the strength of its pharmacological effects.

[0031] Experimental methods: The effects of the present invention group, group a, group b, group c and group d on the proliferation of cotton pellet granulation tissue in rats; the effects on capillary permeability in mice; the effects on pain threshold induced by hot plate in mice; the effects on the activity of isolated uterus in normal rats; and the effects on swimming endurance in Qi-deficient mice.

[0032] I. Effects on the proliferation of cotton pellet granulation tissue in rats

[0033] Experimental materials

[0034] 1. Animal: Wistar rat, female, weighing 200-250g.

[0035] 2. Drugs: Five formulation groups: group a, group b, group c, and group d. Before the experiment, the fine powder of the drug was mixed with distilled water and administered by gavage.

[0036] Experimental methods

[0037] Sixty female Wistar rats, weighing 200–250 g, were randomly divided into 6 groups of 10 each. The rats were groomed 24 hours prior to the experiment. During the experiment, each rat was anesthetized by an intraperitoneal injection of sodium pentobarbital at 40 mg / kg body weight. After anesthesia, the area between the scapulae on the back was disinfected with iodine tincture, deiodized with 75% alcohol, and a 1 cm incision was made. A 20 mg sterile cotton ball was inserted subcutaneously through the incision using forceps. 2 mg of ampicillin was added to the wound, and the wound was immediately sutured. The entire surgical procedure was performed under aseptic conditions. Drug administration began on the day of surgery. The control group received the same volume of physiological saline via gavage. The experimental groups (groups a, b, c, and d) received 1.0 g / kg of the drug via gavage for 8 consecutive days, once daily. On day 9, the rats were sacrificed, the cotton ball was removed, and the granulation tissue was extracted. The tissue was dried in an oven at 60°C for 12 hours and then weighed. The weight of the granuloma was obtained by subtracting the weight of the cotton ball. Experimental results: See Table 1.

[0038] Table 1. Effects on cotton pellet granulation tissue proliferation in rats

[0039]

[0040] Compared with the control group, **P<0.01, *P<0.05; compared with the present invention group, △P<0.05.

[0041] The results showed that the present invention group, group a, group b, group c, and group d had significant inhibitory effects on granulation tissue proliferation in rats. The present invention group showed a highly significant difference compared to the control group (P < 0.01); groups a, b, c, and d showed significant differences compared to the control group (P < 0.05); and groups a, b, c, and d showed significant differences compared to the present invention group (P < 0.05). Therefore, the present invention group had a stronger anti-chronic inflammation effect than groups a, b, c, and d.

[0042] II. Effects on capillary permeability in mice

[0043] Experimental materials

[0044] 1. Animals: Kunming female mice, weighing 20-25g.

[0045] 2. Drugs: Five formulation groups: group a, group b, group c, and group d. Before the experiment, the fine powder of the drug was mixed with distilled water and administered by gavage.

[0046] Experimental methods

[0047] Sixty female Kunming mice, weighing 20–25 g, were randomly divided into 6 groups of 10 mice each. The control group was administered the same volume of physiological saline by gavage. Groups A, B, C, and D were administered the same dose by gavage at a rate of 2.0 g / kg for 7 consecutive days, once daily. 0.5 h after the last administration, each mouse was injected intravenously with 0.1 ml / 10 g of 2% Evans blue saline solution via the tail vein, and simultaneously injected intraperitoneally with 0.2 ml / mouse of 0.6% acetic acid. Twenty minutes later, the mice were sacrificed, and the peritoneal cavity was flushed with 5 ml of distilled water. The flushing fluid was collected, centrifuged for 5 min, and the supernatant was used to measure the absorbance (OD) value. Experimental results: See Table 2.

[0048] Table 2 Effects on capillary permeability in mice

[0049]

[0050] Compared with the control group, **P<0.01, *P<0.05; compared with the present invention group, △P<0.05.

[0051] The results showed that the present invention group, group a, group b, group c, and group d significantly inhibited the increase in capillary permeability induced by acetic acid and had an inhibitory effect on exudation in edema and inflammation. The present invention group showed a highly significant difference compared to the control group (P < 0.01); groups a, b, c, and d showed significant differences compared to the control group (P < 0.05); and groups a, b, c, and d showed significant differences compared to the present invention group (P < 0.05). Therefore, the present invention group had a stronger anti-inflammatory effect than groups a, b, c, and d.

[0052] III. Effects on pain threshold induced by hot plate in mice

[0053] Experimental materials

[0054] 1. Animals: Kunming female mice, weighing 20-25g.

[0055] 2. Drugs: Five formulation groups: group a, group b, group c, and group d. Before the experiment, the fine powder of the drug was mixed with distilled water and administered by gavage.

[0056] Experimental methods

[0057] Adjust the temperature controller of the intelligent hot plate apparatus to maintain the temperature at (55±0.5)℃. Take female mice weighing 20-25g, placing one mouse on the hot plate at a time. The time (s) required for the mouse to lick its hind paw after being placed on the hot plate is used as the mouse's pain threshold. Mice that lick their hind paws for less than 5s, more than 30s, or jump are discarded. Sixty qualified female mice are selected and randomly divided into 6 groups of 10 each. The control group is administered the same volume of physiological saline by gavage. The experimental group, group a, group b, group c, and group d are administered the same drug by gavage at a dose of 2.0g / kg, administered once daily for 7 consecutive days. The pain threshold of the mice is measured 15 minutes after the last administration. Each mouse is measured three times consecutively, with a 5-minute interval between each measurement. The average of the three measurements is calculated. If there is no reaction after 60s, the mouse is removed to avoid burns, and its pain threshold is calculated based on 60s. Experimental results: See Table 3.

[0058] Table 3 Effects of hot plate-induced pain threshold in mice

[0059]

[0060] Compared with the control group, **P<0.01, *P<0.05; compared with the present invention group, △P<0.05.

[0061] The results showed that the present invention group, group a, group b, group c, and group d significantly increased the pain threshold in mice and relieved pain induced by heat stimulation. The present invention group showed a highly significant difference compared to the control group (P < 0.01); groups a, b, c, and d showed significant differences compared to the control group (P < 0.05); and groups a, b, c, and d showed significant differences compared to the present invention group (P < 0.05). Therefore, the present invention group had a stronger analgesic effect than groups a, b, c, and d.

[0062] IV. Effects on the activity of isolated uterus in normal rats

[0063] Experimental materials

[0064] 1. Animal: Wistar rat, female, weighing 200-250g.

[0065] 2. Drugs: Five formulation groups: group a, group b, group c, and group d. Before the experiment, the fine drug powder was mixed with distilled water and set aside.

[0066] Experimental methods

[0067] Sixty female Wistar rats, weighing 200–250 g, were randomly divided into 6 groups of 10 rats each. Two days before the experiment, the rats were subcutaneously injected with diethylstilbestrol (2 mg / kg). During the experiment, the rats were euthanized by cervical spondylosis, and their abdomens were dissected. The adipose tissue around the uterus was gently dissected. A 2 cm long section of the uterus was taken and tied to the ventilation groove and transducer (experimental apparatus) at both ends, and placed in a McBurney bath containing nutrient solution. The temperature was maintained at (37±0.5)℃, and O2 was introduced into the nutrient solution at a rate of approximately 70 bubbles per minute. After the uterine movement stabilized, the normal contraction curve was recorded. Then, the drug solution was added. The control group received the same volume of physiological saline; the experimental group, group a, group b, group c, and group d received the drug solution separately, so that the drug solution dosage in the bath reached 6.0 mg / ml. Changes in uterine motility were observed. Experimental results: See Table 4.

[0068] Table 4. Effects on isolated uterine activity in normal rats

[0069]

[0070] Compared with the control group, **P<0.01, *P<0.05; compared with the present invention group, △P<0.05.

[0071] The results showed that the present invention group, group a, group b, group c, and group d significantly inhibited the contractile activity of isolated uterine smooth muscle from normal rats and reduced the uterine's spontaneous activity. The present invention group showed a highly significant difference compared to the control group (P < 0.01); groups a, b, c, and d showed significant differences compared to the control group (P < 0.05); and groups a, b, c, and d showed significant differences compared to the present invention group (P < 0.05). Therefore, the present invention group had a stronger inhibitory effect on uterine activity and a stronger effect in relieving menstrual cramps than groups a, b, c, and d.

[0072] V. Effects on swimming endurance in Qi-deficient mice

[0073] Experimental materials

[0074] 1. Animals: Kunming female mice, weighing 20-25g.

[0075] 2. Drugs: Five formulation groups: group a, group b, group c, and group d. Before the experiment, the fine powder of the drug was mixed with distilled water and administered by gavage.

[0076] Experimental methods

[0077] Sixty female Kunming mice, weighing 20-25g, were randomly divided into 6 groups of 10 mice each. They were fed a restricted diet of 50g / kg body weight for 8 days to establish a mouse model of qi deficiency. On the 4th day after modeling, the control group was administered the same volume of physiological saline by gavage; the experimental groups (groups a, b, c, and d) were administered the same drug by gavage at 2.0g / kg for 5 consecutive days, once daily. One hour after the last administration, the mice in each group were put into a 10% body weight load and swam in water at 20℃. The mortality indicator was defined as the mouse sinking to the bottom and not resurfacing for 6 seconds. The duration of the weight-bearing swimming was recorded. Experimental results: See Table 5.

[0078] Table 5 Effects on swimming endurance in mice with qi deficiency

[0079]

[0080] Compared with the control group, **P<0.01, *P<0.05; compared with the present invention group, △P<0.05.

[0081] The results showed that the present invention group, group a, group b, group c, and group d significantly prolonged the swimming endurance time of mice with qi deficiency and enhanced their anti-fatigue effect. The present invention group showed a highly significant difference compared to the control group (P < 0.01); groups a, b, c, and d showed significant differences compared to the control group (P < 0.05); and groups a, b, c, and d showed significant differences compared to the present invention group (P < 0.05). Therefore, the present invention group exhibited stronger stress resistance and anti-fatigue effect against qi deficiency symptoms than groups a, b, c, and d.

[0082] Experimental results: The present invention group, group a, group b, group c and group d have significant inhibitory effects on granulation tissue proliferation in rats; significantly inhibit the increase in capillary permeability induced by acetic acid; significantly increase the pain threshold in mice and relieve pain induced by heat stimulation; significantly inhibit the contractile activity of isolated uterine smooth muscle in normal rats and reduce the autonomous activity of the uterus; significantly prolong the swimming endurance time of Qi-deficient mice and enhance the anti-fatigue effect of Qi-deficient mice.

[0083] Conclusion: The pharmacological effects of the present invention group are stronger than those of groups a, b, c, and d in terms of anti-inflammatory, analgesic, uterine autonomous activity, and anti-fatigue effects. Therefore, the present invention group is more effective than groups a, b, c, and d in the clinical treatment of menstrual disorders and dysmenorrhea caused by deficiency of both qi and blood, as well as leukorrhea and abdominal pain caused by pelvic inflammatory disease, adnexitis, and endometritis. The prescription of the present invention group is determined to be the optimal prescription. Detailed Implementation

[0084] Example 1: Preparation of the tablets of the present invention:

[0085] Formulation ratio:

[0086]

[0087] Preparation method:

[0088] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate excipients, mixed well, granulated, dried, and sized. An appropriate amount of lubricant is added, mixed well, and compressed into 1000 tablets. These tablets are then coated with a film to obtain the final product.

[0089] Example 2: Preparation of the capsule formulation of the present invention:

[0090] Formulation ratio:

[0091]

[0092]

[0093] Preparation method:

[0094] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and encapsulated to produce 1000 capsules, thus obtaining the capsule formulation.

[0095] Example 3: Preparation of the granules of the present invention:

[0096] Formulation ratio:

[0097]

[0098] Preparation method:

[0099] The above eleven ingredients are selected from ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and bagged to produce 1000 bags, thus obtaining the granules.

[0100] Example 4: Preparation of the tablets of the present invention:

[0101] Formulation ratio:

[0102]

[0103] Preparation method:

[0104] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate excipients, mixed well, granulated, dried, and sized. An appropriate amount of lubricant is added, mixed well, and compressed into 1000 tablets. These tablets are then coated with a film to obtain the final product.

[0105] Example 5: Preparation of the capsule formulation of the present invention:

[0106] Formulation ratio:

[0107]

[0108] Preparation method:

[0109] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and encapsulated to produce 1000 capsules, thus obtaining the capsule formulation.

[0110] Example 6: Preparation of the granules of the present invention:

[0111] Formulation ratio:

[0112]

[0113] Preparation method:

[0114] The above eleven ingredients are selected from ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and bagged to produce 1000 bags, thus obtaining the granules.

[0115] Example 7: Preparation of the tablets of the present invention:

[0116] Formulation ratio:

[0117]

[0118] Preparation method:

[0119] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate excipients, mixed well, granulated, dried, and sized. An appropriate amount of lubricant is added, mixed well, and compressed into 1000 tablets. These tablets are then coated with a film to obtain the final product.

[0120] Example 8: Preparation of the capsule formulation of the present invention:

[0121] Formulation ratio:

[0122]

[0123] Preparation method:

[0124] The above eleven ingredients are used to decoct ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are then decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and encapsulated to produce 1000 capsules, thus obtaining the capsule formulation.

[0125] Example 9: Preparation of the granules of the present invention:

[0126] Formulation ratio:

[0127]

[0128] Preparation method:

[0129] The above eleven ingredients are selected from ten herbs: honeysuckle vine, large blood vine, licorice root, red ginseng, prepared rehmannia root, dandelion, peony bark, red peony root, Sichuan pepper, and prepared corydalis rhizome. These are decocted twice with 10 times the amount of water, the first time for 2 hours and the second time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.06-1.08 at 85℃-90℃. This extract is then spray-dried into a fine powder. Deer antler is also pulverized into a fine powder. The above deer antler powder and the spray-dried powder are combined with appropriate amounts of excipients, mixed well, granulated, dried, sized, and bagged to produce 1000 bags, thus obtaining the granules.

Claims

1. A traditional Chinese medicine composition for qi and blood deficiency, swelling and pain relief, characterized in that The raw medicinal composition of the Chinese medicine composition is: Lonicera japonica 2600g-2800g Sargentodoxa 2600g-2800g Glycyrrhiza 260g-280g Red ginseng 220g-320g Antler 40g-60g Rehmannia 900g-1100g Dandelion 800g-820g Peony 800g-820g Red peony root 800g-820g Chinese toon 800g-820g Rhizoma Corydalis 800g-820g.

2. The traditional Chinese medicine composition according to claim 1, characterized in that The preferred raw medicinal composition of the Chinese medicine composition is: Lonicera japonica 2702g Sargentodoxa 2702g Glycyrrhiza 270g Red ginseng 270g Antler 54g Rehmannia 1028g Dandelion 811g Peony 811g Red peony root 811g Chinese toon 811g Rhizoma Corydalis 811g.

3. The preparation method of the Chinese medicine composition according to claim 1 or 2, characterized in that: The above eleven flavors, take Lonicera japonica, Sargentodoxa, Glycyrrhiza, red ginseng, Rehmannia, dandelion, peony, red peony root, Chinese toon, Rhizoma Corydalis, a total of ten flavors, add 10 times the amount of water decoct twice, the first time 2 hours, the second time 1 hour, combine the decoction, filter, filter the filtrate, concentrate to 85℃-90℃, measure the relative density of the clear paste to be 1.06-1.08, spray dry into fine powder, crush the antler into fine powder, add the above antler fine powder and spray dried fine powder to the auxiliary material, mix evenly, granulate, dry, whole granulation, add lubricant, mix evenly, press into 1000 tablets, coat with film, and then get the tablets.

4. The preparation method of the Chinese medicine composition according to claim 1 or 2, characterized in that: The above eleven flavors, take Lonicera japonica, Sargentodoxa, Glycyrrhiza, red ginseng, Rehmannia, dandelion, peony, red peony root, Chinese toon, Rhizoma Corydalis, a total of ten flavors, add 10 times the amount of water decoct twice, the first time 2 hours, the second time 1 hour, combine the decoction, filter, filter the filtrate, concentrate to 85℃-90℃, measure the relative density of the clear paste to be 1.06-1.08, spray dry into fine powder, crush the antler into fine powder, add the above antler fine powder and spray dried fine powder to the auxiliary material, mix evenly, granulate, dry, whole granulation, add lubricant, mix evenly, press into 1000 tablets, coat with film, and then get the tablets.

5. The preparation method of the Chinese medicine composition according to claim 1 or 2, characterized in that: The above eleven flavors, take Lonicera japonica, Sargentodoxa, Glycyrrhiza, red ginseng, Rehmannia, dandelion, peony, red peony root, Chinese toon, Rhizoma Corydalis, a total of ten flavors, add 10 times the amount of water decoct twice, the first time 2 hours, the second time 1 hour, combine the decoction, filter, filter the filtrate, concentrate to 85℃-90℃, measure the relative density of the clear paste to be 1.06-1.08, spray dry into fine powder, crush the antler into fine powder, add the above antler fine powder and spray dried fine powder to the auxiliary material, mix evenly, granulate, dry, whole granulation, add lubricant, mix evenly, press into 1000 tablets, coat with film, and then get the tablets.

6. The use of the Chinese medicine composition according to any one of claims 1-2 or the preparation method according to any one of claims 3-5 in the preparation of a drug for treating irregular menstruation, menstrual abdominal pain, leukorrhea, abdominal pain caused by pelvic inflammation, adnexitis, endometritis, and other diseases caused by deficiency of both qi and blood.

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