Traditional Chinese medicine composition for soothing liver and regulating qi as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for soothing liver and regulating qi as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for soothing liver and regulating qi prepared by the invention takes white paeony root, bupleurum chinense, trichosanthes kirilowii maxim, oyster, angelica sinensis, corydalis tuber, selfheal, uniflower swisscentaury root and ligusticum wallichii as raw materials, has the effects of soothing liver and regulating qi, and dispersing blood stasis and eliminating stagnation, and is used for preventing and treating acute mastitis, lobular hyperplasia of mammary glands and fibroma of mammary glands. The preparation method of the traditional Chinese medicine composition is simple, the content of paeoniflorin and the content of saikosaponin a in the product are high, and the medicine effect is remarkable.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for soothing liver and regulating qi, and a preparation method and application thereof. Background Art

[0002] Fibrocystic breast disease is a common breast disease in women, also known as lobular hyperplasia, mammary dysplasia, fibrocystic disease, etc.

[0003] Hyperplasia of the breast includes liver depression and qi stagnation type and Chong and Ren disorder type. Among them, liver depression and qi stagnation type is manifested by breast swelling and pain before or during menstruation, which disappears with mood swings, beaded nodules of varying sizes can be felt on one or both sides, and the lumps are mostly mung bean-sized nodules, or thick cord-like, tough and not hard, movable when pressed, not adhered to deep tissues, unclear state, insufficient menstrual cycle, heavy menstrual flow, chest tightness, depression, irritability. Chong and Ren disorder type is manifested by breast lumps, aggravated pain before or during menstruation, relieved or disappeared after menstruation, delayed menstruation, mild menstrual pain, scanty menstruation, fatigue and weakness, sore waist and cold limbs, and fear of cold in the lower abdomen. A few of those who are not treated for a long time may develop cancer.

[0004] Mental factors are the main cause of breast hyperplasia. Mental stimulation can change the internal environment of the human body, thereby affecting the function of the endocrine system and leading to abnormal secretion of one or more hormones. Negative mental factors such as excessive mental tension and excessive emotional excitement may prevent the breast hyperplasia tissue that should have recovered from recovery or incomplete recovery. Over time, breast hyperplasia will form, and these adverse mental stimulations will aggravate the existing breast hyperplasia symptoms.

[0005] Drugs that soothe the liver and regulate qi can help regulate hormone levels in the body and relieve the symptoms of breast hyperplasia.

[0006] Chinese patent application 201610082398.7 discloses a method for preparing a granular medicine for treating breast hyperplasia. The preparation steps mention that the Chinese medicinal materials used include 297 parts of turtle shell, 297 parts of oyster, 297 parts of selfheal, 198 parts of bupleurum, 178 parts of red peony root, 178 parts of curcuma, 198 parts of ligusticum chuanxiong, 238 parts of rose, 198 parts of angelica, 178 parts of corydalis, and 119 parts of bombyx batryticatus, and the extraction is carried out using microwave extraction technology.

[0007] Chinese patent application 202011015328.2 discloses a Chinese medicine composition for treating breast hyperplasia and preventing cancer in women, including 10-15 grams of angelica, 10-15 grams of chuanxiong, 10-15 grams of white peony root, 10-15 grams of atractylodes, 5-8 grams of licorice, 10-15 grams of bupleurum, 13-17 grams of salvia miltiorrhiza, 13-17 grams of red peony root, 13-17 grams of seaweed, 13-17 grams of pumice, 13-17 grams of selfheal, 8-12 grams of cyperus, 8-12 grams of curcuma, and 8-12 grams of corydalis. grams, Sophora flavescens 8-12 grams, Trichosanthes kirilowii 8-12 grams, Citrus aurantium 8-12 grams, Perilla leaf 8-12 grams, Trichosanthes shell 8-12 grams, roasted Bombyx batryticatus 8-12 grams, Solanum lycopodii 7-11 grams, Corrugated seed 7-11 grams, Tribulus terrestris 13-17 grams, Oroxylum butterfly 13-17 grams, Prunus mume 8-12 grams, Inula flower 8-12 grams, Cat's Claw 8-12 grams, Oyster 8-12 grams, Turtle shell 8-12 grams, Pear root 8-12 grams, Wild Grape root 8-12 grams, Flavour of anise 1-5 grams.

[0008] Chinese patent application 201911344044.5 discloses a traditional Chinese medicine preparation with anti-breast hyperplasia effect, including raw materials bupleurum, angelica, tribulus terrestris, Scrophularia ningpoensis, white peony root, tribulus terrestris, Cynanchum wilfordii, caraway, pinellia ternata, tangerine peel, pumice, oyster, poria, fructus aurantii, curcuma, selfheal, whole trichosanthes, and Corydalis yanhusuo.

[0009] The drugs for treating breast hyperplasia provided in the prior art are complex and the preparation methods are complicated. Therefore, it is necessary to provide a traditional Chinese medicine composition for soothing the liver and regulating qi with a simple formula and a simple preparation process. Summary of the invention

[0010] In view of this, an object of the present invention is to provide a Chinese medicine composition for soothing the liver and regulating qi, which has the effects of soothing the liver and regulating qi, eliminating blood stasis and dispersing nodules, and is used for the prevention and treatment of mastitis, mammary lobular hyperplasia, and mammary fibroids.

[0011] The Chinese medicine composition for soothing the liver and regulating qi of the present invention comprises the following components:

[0012] White peony root, northern bupleurum, trichosanthes, oyster, angelica, corydalis, selfheal, smilax china, and ligusticum chuanxiong.

[0013] Preferably, the Chinese medicine composition for soothing the liver and regulating qi comprises the following components in parts by weight:

[0014] 300-350 parts of white peony root, 300-350 parts of northern bupleurum, 400-450 parts of trichosanthes, 500-600 parts of oyster, 300-350 parts of angelica, 100-200 parts of corydalis, 300-350 parts of selfheal, 300-350 parts of scutellaria, and 200-300 parts of ligusticum chuanxiong.

[0015] Preferably, the Chinese medicine composition for soothing the liver and regulating qi comprises the following components in parts by weight:

[0016] 338 parts of white peony root, 338 parts of northern bupleurum, 423 parts of trichosanthes, 564 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 338 parts of selfheal, 338 parts of schizonepeta, 254 parts of ligusticum.

[0017] Preferably, the dosage form of the Chinese medicine composition for soothing the liver and regulating qi is any one of granules, tablets, capsules, pills, and oral liquid.

[0018] Preferably, the Chinese medicine composition for soothing the liver and regulating qi also includes auxiliary materials.

[0019] More preferably, the auxiliary material is dextrin, and the added amount of dextrin is 5-12% by weight of all raw materials.

[0020] Among the above raw materials, white peony root is the dried root of Paeonia lactiflora Pall. of the Ranunculaceae family. It is dug in summer and autumn, washed, the head, tail and thin roots are removed, boiled in boiling water and then the outer skin is removed or the skin is peeled and then boiled, and then dried. It nourishes blood and regulates menstruation, restrains yin and stops sweating, softens the liver and stops pain, and suppresses liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, cramps in the limbs, headache and dizziness.

[0021] Bupleurum chinense DC. or Bupleurum corzonerifolium Willd., a plant of the Apiaceae family, is a dried root. It is harvested in spring and autumn, the stems, leaves and sand are removed, and it is dried. It can relieve fever, soothe the liver and relieve depression, and raise Yang Qi. It is used for colds and fever, alternating cold and heat, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0022] Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Harms, a plant of the Cucurbitaceae family, is a dried mature fruit. When the fruit is ripe in autumn, it is cut off with the fruit stalk and placed in a ventilated place to dry in the shade. It clears away heat and removes phlegm, relieves chest tightness and resolves stagnation, moisturizes and lubricates the intestines. It is used for cough due to lung heat, turbid yellow and thick phlegm, chest pain, chest congestion, breast abscess, lung abscess, intestinal abscess, and constipation.

[0023] Oysters, shells of Ostrea gigas Thunberg, Ostrea alienwhanensis Crosse or Ostrea rivularis Gould. They can be caught all year round, minced, cleaned and dried. They are used to calm the nerves, nourish the yang and tonify the yin, soften and disperse lumps. They are used for palpitations, insomnia, vertigo and tinnitus, scrofula, phlegm nodules, and masses.

[0024] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Umbelliferae family. It is dug up in late autumn, the fibrous roots and mud are removed, and after the water evaporates slightly, it is tied into small bundles, put on a shed, and slowly smoked dry with fireworks. It can replenish blood and promote blood circulation, regulate menstruation and relieve pain, and moisten the intestines and promote bowel movements. It is used for blood deficiency and chlorosis, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, injuries from falls, carbuncles, ulcers, and constipation due to dry intestines.

[0025] Corydalis yanhusuo is the dried tuber of Corydalis yanhusuo WTWW, a plant of the Poppy family. It is collected in early summer when the stems and leaves wither, the fibrous roots are removed, washed, boiled or steamed in boiling water until there is no white core, taken out, and dried. It promotes blood circulation, promotes qi, and relieves pain. It is used for chest and flank pain, abdominal pain, chest obstruction and heart pain, amenorrhea and dysmenorrhea, postpartum blood stasis, and swelling and pain due to falls.

[0026] Prunella vulgaris, the dried fruit clusters of Prunella vulgaris L., a plant of the Labiatae family. The fruit clusters are harvested in summer when they are brownish red, and then impurities are removed and dried in the sun. It can clear the liver and purge fire, improve eyesight, and relieve swelling. It can be used for red and swollen eyes, night pain in the eyeballs, headaches and dizziness, scrofula, goiters, breast abscesses, breast lumps, and breast pain.

[0027] Rhaponticum uniflorum (L.) DC. is a dried root of the Asteraceae plant. It is dug in spring and autumn, the fibrous roots and mud are removed, and it is dried in the sun. It clears away heat and detoxifies, eliminates carbuncle, promotes lactation, relaxes muscles and unblocks meridians. It is used for breast carbuncle swelling and pain, carbuncle on the back, scrofula, milk obstruction, and dampness and stiffness.

[0028] Chuanxiong is the dried rhizome of the plant Ligusticum chuanxiong Hort. of the Umbelliferae family. It is dug up in summer when the nodes on the stem are prominent and slightly purple, and the sand is removed. It is dried in the sun and then the fibrous roots are removed. It can promote blood circulation and qi, dispel wind and relieve pain. It is used for chest pain, chest and flank pain, swelling and pain due to falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to lumps, headaches, and rheumatic pain.

[0029] The compatibility of the drugs in the present invention is that white peony root soothes the liver, softens the liver, benefits the liver and nourishes the liver, and northern bupleurum soothes the liver and relieves depression, both of which are important drugs for the liver, and are used together as the monarch. Trichosanthes kirilowii relieves chest congestion and stagnation, and oyster softens and relieves congestion, and the two assist the monarch and serve as the minister. Angelica sinensis replenishes blood and promotes blood circulation, Corydalis yanhusuo promotes blood circulation and relieves pain, Prunella vulgaris clears liver fire and relieves depression, and Rhizoma scutellariae relieves heat and toxicity and relieves breast abscesses, and the four drugs are all adjuvants. Chuanxiong promotes blood circulation and qi, and can be used as an adjuvant. All the drugs are used together to play the role of soothing the liver and regulating qi, eliminating blood stasis and dispersing congestion.

[0030] Another object of the present invention is to provide a method for preparing a Chinese medicine composition for soothing the liver and regulating qi, comprising the following steps:

[0031] (1) Prepare white peony root, northern bupleurum, trichosanthes root, oyster, angelica, corydalis, selfheal, scutellaria baicalensis, and ligusticum chuanxiong in proportion;

[0032] (2) Crush the oysters, add water and boil for 1-1.5 hours, then add the remaining raw materials and boil for another 1-2 hours, filter and obtain decoction A and medicinal residue;

[0033] (3) adding water to the medicinal residue and boiling again for 1-2 hours, filtering to obtain decoction B, combining decoction A and decoction B, and preparing the desired dosage form through post-processing.

[0034] Preferably, the weight of the water in step (2) is 9-13 times the weight of all raw materials.

[0035] Preferably, the weight of the water in step (3) is 7-9 times the weight of all raw materials.

[0036] The third object of the present invention is to provide an application of the above-mentioned composition in the preparation of a medicament for soothing the liver and regulating qi.

[0037] Compared with the prior art, the present invention has the following beneficial effects: the present invention provides a Chinese medicine composition for soothing the liver and regulating qi, and a preparation method and application thereof. The present invention uses white peony root, northern bupleurum, trichosanthes root, oyster, angelica, corydalis, selfheal, schisandra, and chuanxiong as raw materials to prepare a Chinese medicine composition for soothing the liver and regulating qi, wherein white peony root soothes the liver, softens the liver, benefits the liver, and nourishes the liver, and northern bupleurum soothes the liver and relieves depression, and they are all important liver medicines, and they are used together as the monarch. Trichosanthes root widens the chest and disperses the knot, and oyster softens and disperses the knot, and the two assist the monarch and serve as the minister. Angelica replenishes blood and promotes blood circulation, corydalis promotes blood circulation and relieves pain, selfheal clears liver fire and disperses depression, and schisandra relieves heat and toxicity and disperses breast abscesses, and the four medicines are all adjuvants. Chuanxiong promotes blood circulation and qi, and can be used as an adjuvant. The raw materials are reasonably compatible, synergistic, and significantly regulate the level of hormone disorders, thereby achieving a significant effect of treating breast hyperplasia. In addition, the raw materials of the present invention are easy to obtain, low in price, low in cost, and have no toxic side effects. The operation is simple and feasible, and the product quality is controllable. DETAILED DESCRIPTION

[0038] The Chinese medicine composition for soothing the liver and regulating qi of the present invention comprises the following components in parts by weight:

[0039] 300-350 parts of white peony root, 300-350 parts of northern bupleurum, 400-450 parts of trichosanthes, 500-600 parts of oyster, 300-350 parts of angelica, 100-200 parts of corydalis, 300-350 parts of selfheal, 300-350 parts of scutellaria, and 200-300 parts of ligusticum chuanxiong.

[0040] Preferably, the dosage form of the Chinese medicine composition for soothing the liver and regulating qi is any one of granules, tablets, capsules, pills, and oral liquid.

[0041] Preferably, the Chinese medicine composition for soothing the liver and regulating qi also includes auxiliary materials.

[0042] More preferably, the auxiliary material is dextrin, and the added amount of dextrin is 5-12% by weight of all raw materials.

[0043] The preparation method of the Chinese medicine composition for soothing the liver and regulating qi of the present invention comprises the following steps:

[0044] (1) Prepare white peony root, northern bupleurum, trichosanthes root, oyster, angelica, corydalis, selfheal, scutellaria baicalensis, and ligusticum chuanxiong in proportion;

[0045] (2) Crush the oysters, add water and boil for 1-1.5 hours, then add the remaining raw materials and boil for another 1-2 hours, filter and obtain decoction A and medicinal residue;

[0046] (3) adding water to the medicinal residue and boiling again for 1-2 hours, filtering to obtain decoction B, combining decoction A and decoction B, and preparing the desired dosage form through post-processing.

[0047] Preferably, the weight of the water in step (2) is 9-13 times the weight of all raw materials.

[0048] Preferably, the weight of the water in step (3) is 7-9 times the weight of all raw materials.

[0049] In a specific embodiment of the present invention, the dosage form of the Chinese medicine composition is granules, and the specific preparation method steps are as follows:

[0050] (1) Prepare white peony root, northern bupleurum, trichosanthes root, oyster, angelica, corydalis, selfheal, scutellaria baicalensis, and ligusticum chuanxiong in proportion;

[0051] (2) Crush the oysters, add 9-13 times the weight of all the raw materials in water and boil for 1-1.5 hours, then add the remaining raw materials and boil for another 1-2 hours, filter and obtain decoction A and medicinal residue;

[0052] (3) adding 7-9 times the weight of all the raw materials to the medicinal residue, boiling again for 1-2 hours, filtering to obtain decoction B, combining decoction A and decoction B, concentrating under reduced pressure to a clear paste with a relative density of 1.05-1.10 (60° C.), adding dextrin in an amount of 2% of the total weight of the raw materials, mixing, spray drying, and then adding dextrin in an amount of 3-10% of the total weight of the raw materials, mixing, and preparing granules.

[0053] The present invention will be further described below in conjunction with the embodiments.

[0054] Example 1

[0055] A Chinese medicinal composition for soothing the liver and regulating qi, comprising the following raw materials: 338 parts of white peony root, 338 parts of northern bupleurum, 423 parts of trichosanthes, 564 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 338 parts of selfheal, 338 parts of smilax china, and 254 parts of ligusticum chuanxiong.

[0056] The preparation method of the traditional Chinese medicine composition for soothing the liver and regulating qi comprises the following steps:

[0057] (1) Prepare white peony root, northern bupleurum, trichosanthes root, oyster, angelica, corydalis, selfheal, scutellaria baicalensis, and ligusticum chuanxiong in proportion;

[0058] (2) Crush the oysters, add 11 times the weight of all the raw materials in water and boil for 1 hour, then add the remaining raw materials and boil for another 1 hour, filter and obtain decoction A and medicinal residue;

[0059] (3) Add 9 times the weight of all the raw materials to the medicinal residue and boil again for 1 hour, filter to obtain decoction B, combine decoction A and decoction B, and concentrate under reduced pressure to obtain a clear paste (relative density of 1.05 at 60° C.), add 2% dextrin by weight of the total weight of the raw materials to the clear paste, spray dry to obtain a spray-dried powder, add 5% dextrin by weight of the total weight of the raw materials to the spray-dried powder, mix well, and dry granulate to obtain a granular dosage form of the drug.

[0060] Example 2

[0061] A Chinese medicine composition for soothing the liver and regulating qi, the raw materials are as follows:

[0062] 300 parts of white peony root, 350 parts of northern bupleurum, 400 parts of trichosanthes, 600 parts of oyster, 300 parts of angelica, 200 parts of corydalis, 300 parts of selfheal, 350 parts of scutellaria, and 200 parts of ligusticum chuanxiong.

[0063] The preparation method is the same as Example 1.

[0064] Example 3

[0065] A Chinese medicine composition for soothing the liver and regulating qi, the raw materials are as follows:

[0066] 350 parts of white peony root, 300 parts of northern bupleurum, 450 parts of trichosanthes, 500 parts of oyster, 350 parts of angelica, 100 parts of corydalis, 350 parts of selfheal, 300 parts of schizonepeta, 300 parts of ligusticum chuanxiong.

[0067] The preparation method is the same as Example 1.

[0068] Comparative Example 1

[0069] By changing the ratio between the components of the composition, a traditional Chinese medicine composition for soothing the liver and regulating qi is provided, and the raw material composition is as follows:

[0070] 250 parts of white peony root, 250 parts of northern bupleurum, 423 parts of trichosanthes, 564 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 430 parts of selfheal, 338 parts of smilax china, 340 parts of ligusticum chuanxiong.

[0071] The preparation method is the same as Example 1.

[0072] Comparative Example 2

[0073] A Chinese medicine composition for soothing the liver and regulating qi, the raw material composition is as in Example 1, except that in Comparative Example 2, Trichosanthes kirilowii is omitted and oyster is added thereto, and the raw material composition is as follows:

[0074] 338 parts of white peony root, 338 parts of northern bupleurum, 987 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 338 parts of selfheal, 338 parts of smilax china, and 254 parts of ligusticum chuanxiong.

[0075] The preparation method is the same as Example 1.

[0076] Comparative Example 3

[0077] A Chinese medicine composition for soothing the liver and regulating qi, the raw material composition is as in Example 1, except that, in Comparative Example 3, oyster is omitted and Trichosanthes kirilowii is added, and the raw material composition is as follows:

[0078] 338 parts of white peony root, 338 parts of northern bupleurum, 987 parts of trichosanthes, 338 parts of angelica, 169 parts of corydalis, 338 parts of selfheal, 338 parts of scutellaria, and 254 parts of ligusticum chuanxiong.

[0079] The preparation method is the same as Example 1.

[0080] Comparative Example 4

[0081] A Chinese medicine composition for soothing the liver and regulating qi, the raw material composition is as in Example 1, except that Prunella vulgaris is omitted in Comparative Example 4, and the raw material composition is as follows:

[0082] 338 parts of white peony root, 338 parts of northern bupleurum, 423 parts of trichosanthes, 564 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 676 parts of scutellaria, and 254 parts of ligusticum.

[0083] The preparation method is the same as Example 1.

[0084] Comparative Example 5

[0085] A Chinese medicine composition for soothing the liver and regulating qi, the raw material composition is as in Example 1, except that the Comparative Example 5 eliminates the radix scutellariae and adds herba prunellae, and the raw material composition is as follows:

[0086] 338 parts of white peony root, 338 parts of northern bupleurum, 423 parts of trichosanthes, 564 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 676 parts of selfheal, 254 parts of ligusticum.

[0087] The preparation method is the same as Example 1.

[0088] The Chinese medicine compositions for soothing the liver and regulating qi prepared in Examples 1-3 and Comparative Examples 1-5 were used to conduct experiments, and the experimental steps were as follows:

[0089] Experiment 1

[0090] (1) After one week of adaptive feeding, female non-pregnant SD rats were used as the modeling group for modeling. The rats were intramuscularly injected with estradiol benzoate at a dose of 0.5 mg / kg / d for 25 consecutive days; then progesterone was intramuscularly injected at a dose of 4 mg / kg / d for 5 consecutive days. At the same time as the first modeling, the rats were irritated by clamping their tails with mousetraps, and the stimulation lasted for 30 minutes, once a day, for 30 consecutive days. Another 6 rats were selected as the blank control group and intramuscularly injected with an equal amount of saline for 30 consecutive days. The modeling group rats had dull and yellow fur, slow weight gain, and the height and diameter of the nipples were significantly greater than those of the blank control group, indicating that the modeling was successful.

[0091] (2) The rats with successful modeling were randomly divided into a model control group, a positive control group and each drug administration group, with 6 rats in each group. The positive control group was given 1.8 mg / kg of tamoxifen citrate, and each drug administration group was given the corresponding group drug by gavage (using physiological saline as the solvent, the granules were prepared into a solution for administration), the dosage was 10 g (calculated as the amount of crude drug) / kg, and the administration volume was 20 mL / kg. The blank control group and the model control group were given an equal volume of physiological saline by gavage, once a day, for 30 consecutive days.

[0092] (3) One hour after the last administration, blood was collected from the abdominal aorta and centrifuged at 3000 r / min for 15 min. The upper serum was collected to detect estradiol (E2), progesterone (P), and prolactin (PRL). The results are shown in Table 1.

[0093] Table 1

[0094]

[0095]

[0096] Note: In Table 1, compared with the blank control group, *P<0.05, **P<0.01; compared with the model control group, #P<0.05, ##P<0.01; compared with the Example 1 group, △P<0.05.

[0097] After mammary hyperplasia, the levels of related hormones are abnormally increased. As can be seen from Table 1, the levels of 3 hormones such as estradiol in the model control group are significantly higher than those in the blank control group (P < 0.05, P < 0.01), indicating that the modeling is successful. Each Chinese medicine composition of the present invention can significantly reduce E2 and PRL levels (P < 0.01), significantly reduce P levels (P < 0.05), and has a stronger effect than the comparative example group, with significant differences (P < 0.05). The pharmaceutical composition prepared by the embodiment of the present application can significantly reduce the levels of related hormones, and better promotes the mammary glands of hyperplasia to return to normal. It can be seen that the Chinese medicine composition of the present application has the effects of soothing the liver and regulating qi, eliminating blood stasis and dispersing stagnation, and can be used for the prevention and treatment of mastitis, mammary lobular hyperplasia, and mammary fibroids.

[0098] Experiment 2

[0099] Prepare the raw materials according to the proportions of Example 1, and then explore the effect of the extraction method on the paste yield.

[0100] Experiment 2-1: Weigh all the raw materials in proportion, totaling 110.27g, first crush the oysters, add 9 times the weight of water of all the raw materials and boil for 1 hour, then add the remaining 8 raw materials, boil for another hour, filter the decoction, add 7 times the weight of water of all the raw materials to the residue again, boil for 1 hour, filter the decoction, combine the 2 decoction filtrates, record the volume, and determine the solids. Calculate the paste rate, paste rate % = solids (g / mL) × filtrate volume (mL) / raw material weight (g) × 100%. At the same time, according to the content determination method under the white peony and bupleurum items in the 2020 edition of the Chinese Pharmacopoeia, the contents of paeoniflorin and saikosaponin a in the solids were detected respectively.

[0101] Experiment 2-2: Weigh all the raw materials in proportion, totaling 110.35g, first crush the oyster, add 11 times the weight of water of all the raw materials and boil for 1 hour, then add the remaining 8 kinds of raw materials, boil for another hour, filter the decoction, add 9 times the weight of water of all the raw materials to the residue again, boil for 1 hour, filter the decoction, combine the filtrates of the two decoctions, record the volume, and determine the solids. Calculate the paste rate and the content of paeoniflorin and saikosaponin a in the solids according to Experiment 2-1.

[0102] Experiment 2-3: Weigh all the raw materials in proportion, totaling 110.45g, first crush the oyster, add 9 times the weight of water of all the raw materials and boil for 1 hour, then add the remaining 8 kinds of raw materials, boil for another 2 hours, filter the decoction, add 7 times the weight of water of all the raw materials to the residue again, boil for 1 hour, filter the decoction, combine the filtrates of the two decoctions, record the volume, and determine the solids. Calculate the paste rate and the content of paeoniflorin and saikosaponin a in the solids according to Experiment 2-1.

[0103] Experiment 2-4: Weigh all the raw materials in proportion, totaling 110.34g, first crush the oyster, add 13 times the weight of water of all the raw materials and boil for 1 hour, then add the remaining 8 kinds of raw materials, boil for another 2 hours, filter the decoction, record the volume, and determine the solids. Calculate the paste rate and the content of paeoniflorin and saikosaponin a in the solids according to Experiment 2-1.

[0104] The results are shown in Table 2.

[0105] Table 2

[0106]

[0107] Note: Comprehensive score = ointment yield / maximum ointment yield in 4 groups of experiments × 40% + paeoniflorin content / maximum paeoniflorin content in 4 groups of experiments × 30% + saikosaponin a content / maximum saikosaponin a content in 4 groups of experiments × 30%.

[0108] As can be seen from Table 2, the comprehensive score of Experiment 2-2 is the highest, and the parameters of this experiment are determined to be the optimal extraction process.

[0109] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for soothing the liver and regulating qi, characterized in that: Includes the following components: White peony root, northern bupleurum, trichosanthes, oyster, angelica, corydalis, selfheal, smilax china, and ligusticum chuanxiong.

2. The Chinese medicine composition for soothing the liver and regulating qi according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 300-350 parts of white peony root, 300-350 parts of northern bupleurum, 400-450 parts of trichosanthes, 500-600 parts of oyster, 300-350 parts of angelica, 100-200 parts of corydalis, 300-350 parts of selfheal, 300-350 parts of scutellaria, and 200-300 parts of ligusticum chuanxiong.

3. The Chinese medicine composition for soothing the liver and regulating qi according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 338 parts of white peony root, 338 parts of northern bupleurum, 423 parts of trichosanthes, 564 parts of oyster, 338 parts of angelica, 169 parts of corydalis, 338 parts of selfheal, 338 parts of schizonepeta, 254 parts of ligusticum.

4. The Chinese medicine composition for soothing the liver and regulating qi according to claim 1, characterized in that: The dosage form of the traditional Chinese medicine composition for soothing the liver and regulating qi is any one of granules, tablets, capsules, pills and oral liquid.

5. The Chinese medicine composition for soothing the liver and regulating qi according to claim 1, characterized in that: The Chinese medicinal composition for soothing the liver and regulating qi also includes auxiliary materials.

6. The Chinese medicine composition for soothing the liver and regulating qi according to claim 5, characterized in that: The auxiliary material is dextrin, and the added amount of the dextrin is 5-12% of the weight of all raw materials.

7. The method for preparing the Chinese medicinal composition for soothing the liver and regulating qi according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Prepare white peony root, northern bupleurum, trichosanthes root, oyster, angelica, corydalis, selfheal, scutellaria baicalensis, and ligusticum chuanxiong in proportion; (2) Crush the oysters, add water and boil for 1-1.5 hours, then add the remaining raw materials and boil for another 1-2 hours, filter and obtain decoction A and medicinal residue; (3) adding water to the medicinal residue and boiling again for 1-2 hours, filtering to obtain decoction B, combining decoction A and decoction B, and preparing the desired dosage form through post-processing.

8. The method for preparing the Chinese medicinal composition for soothing the liver and regulating qi according to claim 7, characterized in that: The weight of the water in step (2) is 9-13 times the weight of all raw materials.

9. The method for preparing the Chinese medicinal composition for soothing the liver and regulating qi according to claim 7, characterized in that: The weight of the water in step (3) is 7-9 times the weight of all raw materials.

10. Use of the composition according to any one of claims 1 to 6 in the preparation of a medicament for soothing the liver and regulating qi.

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