Traditional Chinese medicine composition and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition which is prepared from antler, polygonum multiflorum, fructus cnidii, moutan bark, radix paeoniae rubra, kelp, radix curcumae and oyster by the following preparation steps: water extraction of the antler, distillation of the moutan bark and alcohol extraction of the polygonum multiflorum and the radix paeoniae rubra; extracting volatile oil from decoction dregs after distillation of moutan bark, decoction dregs after alcohol extraction of polygonum multiflorum and radix paeoniae rubra, fructus cnidii, kelp, radix curcumae and oyster by water extraction, and concentrating and performing alcohol precipitation on a water extract; the prepared traditional Chinese medicine composition has a better anti-analgesic effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceuticals, and relates to a traditional Chinese medicine composition and a preparation method thereof. Background Art

[0002] Patent document CN1265810C discloses a pharmaceutical composition for treating breast pain and breast masses caused by mammary hyperplasia and a preparation method thereof. The composition mainly replenishes the liver and kidney, regulates the thoroughfare and conception vessels, and secondarily activates blood circulation to dissipate stasis, resolve phlegm, and disperse swelling and relieve pain, that is, it simultaneously has the effects of hormone regulation, anti - inflammation, detumescence, and analgesia, so as to treat both the principal and secondary aspects of the disease, improve the curative effect and consolidate it. The composition is mainly made from the following raw materials in parts by weight: 5.3 - 12.3 parts of pilose antler, 5.3 - 12.3 parts of fleece - flower root, 5.3 - 12.3 parts of cnidium fruit, 5.3 - 12.3 parts of cortex moutan, 5.3 - 12.3 parts of red peony root, 5.3 - 12.3 parts of thallus laminariae, and 13.7 - 19.7 parts of oyster.

[0003] There is still a need to develop a traditional Chinese medicine composition with better curative effect and better quality. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition with better curative effect and a preparation method thereof.

[0005] On the one hand, the present invention provides a traditional Chinese medicine composition, which is made from 5.3 - 12.3 parts of pilose antler, 5.3 - 12.3 parts of fleece - flower root, 5.3 - 12.3 parts of cnidium fruit, 5.3 - 12.3 parts of cortex moutan, 5.3 - 12.3 parts of red peony root, 5.3 - 12.3 parts of thallus laminariae, 5.3 - 12.3 parts of turmeric root - tuber, and 13.7 - 19.7 parts of oyster as raw materials.

[0006] Further, the raw materials are 7.3 - 9.3 parts of pilose antler, 7.3 - 9.3 parts of fleece - flower root, 7.3 - 9.3 parts of cnidium fruit, 7.3 - 9.3 parts of cortex moutan, 7.3 - 9.3 parts of red peony root, 7.3 - 9.3 parts of thallus laminariae, 7.3 - 9.3 parts of turmeric root - tuber, and 15.7 - 17.7 parts of oyster; more preferably, 8.3 parts of pilose antler, 8.3 parts of fleece - flower root, 8.3 parts of cnidium fruit, 8.3 parts of cortex moutan, 8.3 parts of red peony root, 8.3 parts of thallus laminariae, 8.3 parts of turmeric root - tuber, and 16.6 parts of oyster.

[0007] The composition of the present invention is prepared by the following steps, including:

[0008] Step a): Extract pilose antler with water to obtain pilose antler extract A;

[0009] Step b): Distill cortex moutan by steam distillation, collect the distillate, refrigerate, filter by suction to obtain paeonol crystals; filter cortex moutan to obtain cortex moutan residue and aqueous solution for standby;

[0010] Step c-1): Take Polygonum multiflorum Thunb. and Paeonia lactiflora Pall., add 65-75% ethanol at 18-22 times the weight of the medicinal materials for reflux extraction, filter, and combine the ethanol extracts to obtain the standby extract C1.

[0011] Step c-2): Take Cnidium monnieri (L.) Cuss., Ecklonia kurome Okamura, Oyster, Curcuma aromatica Salisb., and combine them with the medicinal residues of Paeonia suffruticosa Andr. and the medicinal residues after extraction of Polygonum multiflorum Thunb. and Paeonia lactiflora Pall., soak for 1.8-2.5 hours, extract with water 3 times, and collect the volatile oils of Cnidium monnieri (L.) Cuss. and Curcuma aromatica Salisb. separately during the first extraction; combine the three water extracts and the aqueous solution described in step b), concentrate to a density of 1.05-1.10 at 60 °C, let it cool, adjust the alcohol content to 70% with ethanol, refrigerate, filter off the precipitate to obtain the alcohol precipitation solution C2.

[0012] Step d): Mix and process the alcohol precipitation solution C2, the standby extract C1, the antler extract A, paeonol, and the volatile oils to prepare a composition.

[0013] Among them, the water extraction method described in step a) is reflux extraction; the water consumption is 8-14 times the weight of the antler, preferably 9-12 times, and further preferably 10 times; the extraction times are 2-3 times, preferably 3 times; the extraction time is 2-3 hours, preferably 2 hours; furthermore, soak for 0.5-2 hours before refluxing, preferably soak for 1 hour.

[0014] Among them, the volume of the distilled liquid collected in step b) is 9-11 times the weight of the Cortex Moutan medicinal materials, preferably 10 times; the water consumption for distilling Cortex Moutan is 14-16 times the weight of Cortex Moutan; the refrigeration temperature is 0-10 °C, preferably 5 °C, and the refrigeration time is 20-50 hours, further 24-48 hours.

[0015] Among them, the number of extractions described in step c~1) is 2-4 times, preferably 3 times, the extraction time is 1-2 hours, preferably 1.5 hours; the water consumption for water extraction in step c-2) is 8-12 times the total weight of the four medicinal materials of Cnidium monnieri (L.) Cuss., Curcuma aromatica Salisb., Oyster, and Ecklonia kurome Okamura, further 10 times; the ethanol with the alcohol content of the condition is 95% ethanol; the refrigeration temperature is 0-10 °C, preferably 5 °C, and the refrigeration time is 35-55 hours, further 40-50 hours.

[0016] Among them, before the alcohol precipitation solution C2 and the spare extraction solution C1 in step d) are mixed, they are combined, ethanol is recovered under reduced pressure and concentrated to an extract C with a relative density of 1.05 - 1.10; before the paeonol and the volatile oil are mixed, the crystals of paeonol are dissolved in 1 - 3 times the amount of anhydrous ethanol by weight, mixed with the volatile oil, and then 3 - 5 times the amount of β-cyclodextrin by weight and an appropriate amount of 20% - 60% ethanol, based on the total weight of paeonol and the volatile oil of Cnidium monnieri, are added in portions and ground at 40 - 55°C. The obtained paste is dried in vacuo at 30 - 60°C to obtain an inclusion compound F; the extract A is a concentrate of the water extract obtained by water extraction, and preferably the concentrate is a thick paste A with a relative density of 1.05 - 1.15 at 60°C.

[0017] Among them, the extract C is mixed with the extract A, dried, and an extract powder E is prepared. The extract powder E is mixed with the inclusion compound F to prepare the traditional Chinese medicine composition.

[0018] Furthermore, for the traditional Chinese medicine composition of the present invention, in the steps:

[0019] Step a): The antler is soaked in 8 - 14 times the amount of water for 0.5 - 2 hours, decocted 2 - 3 times, and the water extract is concentrated to a relative density of 1.05 - 1.15 at 60°C to obtain the extract A;

[0020] Step b): Cortex Moutan is subjected to steam distillation with 14 - 16 times its weight of water, and the distillate is collected until the amount reaches 9 - 11 times the weight of the Cortex Moutan medicinal material. It is refrigerated at 0 - 10°C for 24 - 48 hours, and then filtered to obtain paeonol crystals; the medicinal residues are filtered to obtain the Cortex Moutan medicinal residues and the aqueous solution for standby.

[0021] Step c): First, Polygonum multiflorum Thunb. and Radix Paeoniae Rubra are added with 18 - 22 times their weight of 65% - 75% ethanol and refluxed for extraction 2 - 3 times, 1 - 2 hours each time. The ethanol extraction solutions are combined to obtain the standby extraction solution C1; Cnidium monnieri, Ecklonia kurome, Oyster, and Curcuma aromatica Salisb. are combined with the Cortex Moutan medicinal residues and the medicinal residues after extraction of Polygonum multiflorum Thunb. and Radix Paeoniae Rubra, and 8 - 12 times the amount of water based on the total weight of the four medicinal materials of Cnidium monnieri, Curcuma aromatica Salisb., Oyster, and Ecklonia kurome is added, and decocted 3 times, 1.8 - 2.5 hours each time. At the same time, the volatile oils of Cnidium monnieri and Curcuma aromatica Salisb. are collected and stored separately. The three decoction solutions and the aqueous solution in step b) are combined, concentrated to a density of 1.05 - 1.10 at 60°C, the ethanol content is adjusted to 70% with ethanol, refrigerated at 0 - 10°C for 35 - 55 hours, the precipitate is filtered off, the alcohol precipitation solution is combined with the above standby extraction solution C1, ethanol is recovered under reduced pressure and concentrated to a relative density of 1.05 - 1.10 to obtain the extract C; the extract C is combined with the extract A, stirred evenly, dried, and pulverized to obtain the extract powder E;

[0022] Step e): Dissolve the crystallization of paeonol in 1 - 3 times its weight of absolute ethanol, mix it evenly with the volatile oil, then add β - cyclodextrin in an amount of 3 - 5 times the total weight of paeonol and the volatile oil of Cnidium monnieri (L.) Cuss. and an appropriate amount of ethanol with a concentration of 20% - 60% in portions, grind at 40 - 55 °C, and vacuum - dry the obtained paste at 30 - 60 °C to obtain the inclusion compound.

[0023] Step f): Mix the extract powder E in step d) with the inclusion compound in step e) to prepare the composition.

[0024] The traditional Chinese medicine composition described in the present invention further includes pharmaceutically acceptable excipients.

[0025] On the other hand, the present invention provides a preparation method of a traditional Chinese medicine composition, which is characterized by including the following steps:

[0026] Take raw materials: 5.3 - 12.3 parts of antler, 5.3 - 12.3 parts of Polygonum multiflorum Thunb., 5.3 - 12.3 parts of Cnidium monnieri (L.) Cuss., 5.3 - 12.3 parts of Cortex Moutan, 5.3 - 12.3 parts of Radix Paeoniae Rubra, 5.3 - 12.3 parts of Ecklonia kurome, 5.3 - 12.3 parts of Curcuma aromatica Salisb., and 13.7 - 19.7 parts of Oyster.

[0027] Step a): Soak the antler in 8 - 14 times its weight of water for 0.5 - 2 hours, then decoct it 2 - 3 times, concentrate the water extract to a relative density of 1.05 - 1.15 at 60 °C in summer to obtain extract A.

[0028] Step b): Perform steam distillation on Cortex Moutan with 14 - 16 times its weight of water, collect the distillate until it reaches 9 - 11 times the weight of the Cortex Moutan medicinal material, refrigerate at 0 - 10 °C for 24 - 48 hours, filter to obtain the crystallization of paeonol; filter the medicinal residues to obtain the Cortex Moutan medicinal residues and the aqueous solution for later use.

[0029] Step c): First, take Polygonum multiflorum Thunb. and Radix Paeoniae Rubra, add 18 - 22 times the weight of the medicinal materials of 65% - 75% ethanol for reflux extraction 2 - 3 times, each time for 1 - 2 hours, combine the ethanol extracts to obtain the standby extract C1; take Cnidium monnieri (L.) Cuss., Ecklonia kurome, Oyster, Curcuma aromatica Salisb., combine them with the Cortex Moutan medicinal residues and the medicinal residues after extraction of Polygonum multiflorum Thunb. and Radix Paeoniae Rubra, add 8 - 12 times the weight of water based on the total weight of the four medicinal materials of Cnidium monnieri (L.) Cuss., Curcuma aromatica Salisb., Oyster, and Ecklonia kurome, decoct 3 times, each time for 1.8 - 2.5 hours, collect the volatile oils of Cnidium monnieri (L.) Cuss. and Curcuma aromatica Salisb., store them separately, combine the three decoction liquids and the aqueous solution in step b), concentrate to a density of 1.05 - 1.10 at 60 °C, adjust the ethanol content to 70% with ethanol, refrigerate at 0 - 10 °C for 35 - 55 hours, filter to remove the precipitate, combine the alcohol - precipitated solution with the above - mentioned standby extract C1, recover ethanol under reduced pressure and concentrate to a relative density of 1.05 - 1.10 to obtain extract C; combine extract C with extract A, stir evenly, dry, and pulverize to obtain extract powder E.

[0030] Step e): Dissolve the crystallization of paeonol in 1 - 3 times the amount of absolute ethanol by weight, mix it with the volatile oil, then add β - cyclodextrin in an amount of 3 - 5 times the total weight of paeonol and the volatile oil of Cnidium monnieri (L.) Cuss. and an appropriate amount of ethanol with a concentration of 20% - 60% in portions, grind at 40 - 55 °C, and vacuum - dry the obtained paste at 30 - 60 °C to obtain the inclusion compound.

[0031] Step f): Mix the extract powder E from step d) with the inclusion compound from step e) to prepare the composition.

[0032] The present invention adopts a suitable traditional Chinese medicine preparation process, enabling the complete extraction of active ingredients, high extraction efficiency, stable quality, better and more reliable curative effects.

[0033] The traditional Chinese medicine extract of the present invention can be used in a pharmaceutical composition for treating or preventing anxiety disorders and / or depression. Through the combination of specific raw materials, the drug effects of each ingredient produce a synergistic effect, thereby effectively treating or preventing anxiety disorders and / or depression.

[0034] The traditional Chinese medicine extract of the present invention treats the breast pain and breast masses caused by hyperplasia of mammary glands. This composition mainly replenishes the liver and kidney, regulates the thoroughfare and conception vessels, and secondarily promotes blood circulation to remove stasis, resolve phlegm, disperse stasis and relieve pain, that is, it simultaneously has the effects of hormone regulation, anti - inflammation, detumescence and analgesia, thus treating both the symptoms and the root causes and having better curative effects.

[0035] The antler is the ossified horn of Cervus elaphus Linnaeus or Cervus Nippon Temminck of the Cervidae family, or the horn base shed in the following spring after sawing the antler. The fleece-flower root is the dried tuberous root of Polygonum multiflorum Thunb. of the Polygonaceae family. The fruit of cnidium is the dried ripe fruit of Cnidium monnieri (L.) Cuss. of the Umbelliferae family. The cortex moutan is the dried root bark of Paeonia suffruticosa Andr. of the Ranunculaceae family. The radix paeoniae rubra is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch of the Ranunculaceae family. The kelp is the dried thallus of Laminaria japonica Aresch. of the Laminariaceae family or Ecklonia kurome Okam. of the Alariaceae family. The oyster is the shell of Ostrea gigas Thunberg, Ostrea talienwhanensis Crosse or Ostrea rivularis Goould of the Ostreidae family. The turmeric root-tuber is the dried tuberous root of Curcuma wenyujin Y.H. Chen et C.L. Ling, Curcuma longa L., Curcuma kwangsiensis S.G. Lee et C.F. Liang or Curcuma phaeocaulis Val. of the Zingiberaceae family. Preferably, it is the first one listed among the said medicinal flavors. Detailed implementation manners

[0036] The following examples are used to further describe the present invention, but these examples do not limit the scope of the present invention.

[0037] The decocting described in the present invention has the same effect as the reflux extraction method.

[0038] The different concentrations of ethanol described in the present invention, such as 70% ethanol, refer to the ethanol aqueous solution measured by volume ratio.

[0039] Preparation of the traditional Chinese medicine composition in Example 1

[0040] Weigh each raw material medicine according to the weight ratio: 833 g of antler, 833 g of fleece-flower root, 833 g of fruit of cnidium, 833 g of cortex moutan, 833 g of radix paeoniae rubra, 833 g of turmeric root-tuber, 833 g of kelp, and 1666 g of oyster.

[0041] Soak the deer antler in 10 times its weight of water for 1 hour, decoct it 3 times, 2 hours each time. Combine the decoction liquids and concentrate to a relative density of 1.15 (at 60 °C) to obtain thick extract A.

[0042] For Cortex Moutan, add 14 times its weight of water and perform steam distillation. Collect the distillate until it reaches 10 times the weight of the medicinal materials. Refrigerate at 5 °C for 24 hours, then perform suction filtration to obtain paeonol crystals. Filter the medicinal residues, and reserve the Cortex Moutan residues and the obtained aqueous solution.

[0043] Add the prescribed amounts of Polygonum multiflorum Thunb. and Radix Paeoniae Rubra to 20 times their weight of 70% ethanol and reflux for extraction 3 times, 1.5 hours each time. Combine the ethanol extracts and reserve as C1.

[0044] Take the remaining medicinal materials in the prescription, combine them with the residues of Cortex Moutan, Polygonum multiflorum Thunb., and Radix Paeoniae Rubra, add 10 times their weight (calculated based on the four medicinal materials of Fructus Cnidii, Radix Curcumae, Concha Ostreae, and Thallus Laminariae) of water, soak for 2 hours, and decoct 3 times, 2 hours each time. During the first decoction, separately collect and store the volatile oils of Fructus Cnidii and Radix Curcumae. Combine the 3 times of decoction liquids and the Cortex Moutan aqueous solution, concentrate to a relative density of 1.08 (at 60 °C), let it cool, add 95% ethanol to adjust the alcohol content to 70%, refrigerate at 5 °C for 45 hours, filter, combine the alcohol precipitation liquid with the above reserved C1, recover ethanol under reduced pressure and concentrate to an extract C with a relative density of 1.10.

[0045] Combine the above extract C with the deer antler extract A, stir evenly, perform vacuum drying, pulverize, and sieve to obtain extract powder E for reserve.

[0046] Dissolve the paeonol crystals in 2 times their weight of absolute ethanol, mix evenly with the above volatile oils of Fructus Cnidii and Radix Curcumae, add 4 times the total weight of paeonol and volatile oils of β - cyclodextrin and an appropriate amount of 40% ethanol in portions, grind evenly, and grind at 40 °C for 6 hours. Vacuum dry the obtained paste at 40 °C to obtain inclusion compound F.

[0047] Mix the above dry extract powder E and inclusion compound F evenly to prepare the traditional Chinese medicine composition of the present invention.

[0048] An appropriate amount of starch and talcum powder can be added to this composition, granulated, filled into capsules to prepare 1000 capsules, each 0.5 g (equivalent to the weight of the original medicinal materials).

[0049] Preparation of the traditional Chinese medicine composition in Example 2

[0050] Weigh each raw material medicine according to the weight ratio: deer antler 833 g, Polygonum multiflorum Thunb. 833 g, Fructus Cnidii 833 g, Cortex Moutan 833 g, Radix Paeoniae Rubra 833 g, Radix Curcumae 833 g, Thallus Laminariae 833 g, Concha Ostreae 1666 g.

[0051] Soak the deer antler in 10 times its weight of water for 1 hour, decoct it 3 times, 2 hours each time. Combine the decoction liquids and concentrate to a relative density of 1.15 (at 60 °C) to obtain thick extract A.

[0052] Moutan Cortex, add 16 times the amount of water, perform steam distillation, collect the distillate until it reaches 10 times the weight of the medicinal material, refrigerate at 5°C for 48 hours, and perform suction filtration to obtain paeonol crystals. Filter the medicinal residues, and reserve the Moutan Cortex medicinal residues and the aqueous solution.

[0053] Add the prescribed amounts of Polygonum multiflorum Thunb. and Paeonia lactiflora Pall. to 18 times 68% ethanol and reflux for extraction 3 times, each time for 1.5 hours. Combine the ethanol extracts and reserve C1.

[0054] Take the remaining medicinal materials in the prescription, combine them with the residues of Moutan Cortex, Polygonum multiflorum Thunb., and Paeonia lactiflora Pall., add 10 times the amount of water (calculated based on the four medicinal materials of Cnidium monnieri (L.) Cuss., Curcuma aromatica Salisb., Oyster, and Ecklonia kurome Okam.), soak for 2.5 hours, decoct 3 times, each time for 2 hours. Separate and collect the volatile oil during the first decoction and store it separately. Combine the 3 decoction liquids and the Moutan Cortex aqueous solution, concentrate to a relative density of 1.10 (60°C), let it cool, add 95% ethanol to adjust the alcohol content to 70%, refrigerate at 5°C for 40 hours, filter, combine the alcohol precipitation liquid with the above reserved C1, recover ethanol under reduced pressure and concentrate to an extract C with a relative density of 1.10.

[0055] Combine the above extract C with antler extract A, stir evenly, perform vacuum drying, pulverize, and sieve to obtain extract powder E for reserve.

[0056] Dissolve the paeonol crystals in 2 times the amount of absolute ethanol, mix evenly with the above-mentioned volatile oils of Cnidium monnieri (L.) Cuss. and Curcuma aromatica Salisb., add 4 times the total amount of paeonol and volatile oil of β-cyclodextrin and an appropriate amount of 40% ethanol in portions, grind evenly at 40°C for 6 hours, and vacuum dry the obtained paste at 40°C to obtain inclusion complex F.

[0057] Mix the above dry extract powder E and inclusion complex F evenly to prepare the traditional Chinese medicine composition of the present invention.

[0058] Preparation of the traditional Chinese medicine composition in Example 3

[0059] Weigh each raw material medicine according to the weight ratio: 833 g of antler, 833 g of Polygonum multiflorum Thunb., 833 g of Cnidium monnieri (L.) Cuss., 833 g of Moutan Cortex, 833 g of Paeonia lactiflora Pall., 833 g of Curcuma aromatica Salisb., 833 g of Ecklonia kurome Okam., 1666 g of Oyster.

[0060] First, soak the antler in 10 times the amount of water for 1 hour, decoct 3 times, each time for 2 hours, combine the decoction liquids, and concentrate to a relative density of 1.15 (60°C) to obtain thick paste A.

[0061] Moutan Cortex, add 15 times the amount of water, perform steam distillation, collect the distillate until it reaches 10 times the weight of the medicinal material, refrigerate at 5°C for 24 hours, and perform suction filtration to obtain paeonol crystals. Filter the medicinal residues, and reserve the Moutan Cortex medicinal residues and the aqueous solution.

[0062] Add the prescribed amounts of Polygonum multiflorum Thunb. and Paeonia lactiflora Pall. to 22 times 73% ethanol and reflux for extraction 3 times, each time for 1.5 hours. Combine the ethanol extracts and reserve C1.

[0063] Take the remaining medicinal materials of the prescription, combine them with the residues of Cortex Moutan, Radix Polygoni Multiflori, and Radix Paeoniae Rubra, add 11 times the amount of water (calculated based on the four medicinal materials of Fructus Cnidii, Radix Curcumae, Concha Ostreae, and Thallus Laminariae), soak for 1.8 hours, decoct 3 times, each time for 2 hours. During the first decoction, separate and collect the volatile oil for storage separately. Combine the 3 decoction liquids and the water solution of Cortex Moutan, concentrate to a relative density of 1.05 (60 °C), let it cool, adjust the alcohol content to 70% with 95% ethanol, refrigerate for 50 hours, filter, combine the alcohol precipitation liquid with the above-mentioned reserved C1, recover ethanol under reduced pressure and concentrate to an extract C with a relative density of 1.10.

[0064] Combine the above-mentioned extract C with antler extract A, stir evenly, dry in vacuum, pulverize, and sieve to obtain extract powder E for standby.

[0065] Dissolve the crystals of paeonol in 2 times the amount of absolute ethanol, mix it evenly with the above-mentioned volatile oils of Fructus Cnidii and Radix Curcumae, add 4 times the total amount of paeonol and volatile oil of β-cyclodextrin and an appropriate amount of 40% ethanol in portions, grind evenly, grind at 40 °C for 6 hours, and vacuum-dry the obtained paste at 40 °C to obtain inclusion compound F.

[0066] Mix the above-mentioned dry extract powder E and inclusion compound F evenly to prepare the traditional Chinese medicine composition of the present invention.

[0067] Preparation of the traditional Chinese medicine composition in Example 4

[0068] Weigh each raw material medicine according to the weight ratio: 733 g of antler, 933 g of Radix Polygoni Multiflori, 733 g of Fructus Cnidii, 933 g of Cortex Moutan, 733 g of Radix Paeoniae Rubra, 933 g of Radix Curcumae, 733 g of Thallus Laminariae, 1770 g of Concha Ostreae.

[0069] Prepare the traditional Chinese medicine composition of the present invention according to the method of Example 3.

[0070] Preparation of the traditional Chinese medicine composition in Example 5

[0071] Weigh each raw material medicine according to the weight ratio: 933 g of antler, 733 g of Radix Polygoni Multiflori, 933 g of Fructus Cnidii, 733 g of Cortex Moutan, 933 g of Radix Paeoniae Rubra, 733 g of Radix Curcumae, 933 g of Thallus Laminariae, 1570 g of Concha Ostreae.

[0072] Prepare the traditional Chinese medicine composition of the present invention according to the method of Example 1.

[0073] Preparation of the traditional Chinese medicine composition in Example 6

[0074] Weigh each raw material medicine according to the weight ratio: 533 g of antler, 533 g of Radix Polygoni Multiflori, 533 g of Fructus Cnidii, 533 g of Cortex Moutan, 533 g of Radix Paeoniae Rubra, 533 g of Radix Curcumae, 533 g of Thallus Laminariae, 1370 g of Concha Ostreae.

[0075] The traditional Chinese medicine composition of the present invention was prepared according to the method of Example 2.

[0076] Preparation of the traditional Chinese medicine composition in the comparative preparation example

[0077] It was prepared with reference to Example 1 of the prior art CN1265810C.

[0078] Weigh each raw material medicine according to the weight ratio: 833 g of antler, 833 g of fleece-flower root, 833 g of cnidium fruit, 833 g of moutan bark, 833 g of red peony root, 833 g of turmeric root-tuber, 833 g of kelp, and 1666 g of oyster.

[0079] First, soak the antler in 12 times the amount of water for 1 hour, decoct it 3 times, 2 hours each time, combine the decoction liquids, and concentrate to a relative density of 1.05 to obtain thick paste A.

[0080] Perform steam distillation on the moutan bark, collect the distillate until it reaches 10 times the weight of the medicinal materials, refrigerate for 24 hours, and filter by suction to obtain paeonol crystal B. Reserve the moutan bark medicinal residues and the aqueous solution.

[0081] Add the fleece-flower root and red peony root in the prescribed amount and reflux extract them 3 times with 70% ethanol for 1.5 hours each time. Combine the ethanol extract liquids and reserve C1. Separately, combine the remaining medicinal materials in the prescription with the moutan bark, fleece-flower root, red peony root and other medicinal residues, add 10 times the amount of water, decoct 3 times, 2 hours each time, separate and collect the cnidium fruit volatile oil and store it separately. Combine the 3 times of decoction liquids, concentrate to a relative density of 1.20, add 95% ethanol to adjust the alcohol content to 70%, refrigerate, filter, combine the alcohol precipitation liquid with the above reserved C1, and recover ethanol under reduced pressure and concentrate to an extract C with a relative density of 1.10.

[0082] Combine the above extract C with the antler extract A, stir evenly, dry it under vacuum, pulverize it, and sieve it to obtain extract powder E for reserve.

[0083] Dissolve the paeonol crystal B in 2 times the amount of absolute ethanol, mix it evenly with the above cnidium fruit volatile oil, add the total amount of paeonol and volatile oil in 4 times the amount of β-cyclodextrin and an appropriate amount of 40% ethanol in portions and grind it evenly. Grind it at 40 °C for 6 hours, and vacuum dry the obtained paste at 40 °C to obtain inclusion complex F.

[0084] Mix the above dry extract powder E with the inclusion complex F to prepare the traditional Chinese medicine composition of the present invention.

[0085] An appropriate amount of starch and talc powder can be added to this composition, granulated, filled into capsules to prepare 1000 capsules, each capsule being 0.5 g (equivalent to the weight of the original medicinal materials).

[0086] Analgesic effect of Example 7 on pain in mice

[0087] Fifty female mice (18 - 22 g) were randomly divided into 5 groups, with 10 mice in each group. (1) Model group; (2) Aspirin group (0.6 g / kg); (3) Control group (36 g crude drug / kg); (4) High-dose drug group (36 g crude drug / kg); (5) Low-dose drug group (24 g crude drug / kg).

[0088] Thirty minutes after intragastric administration of drugs to each group of mice, 0.2 ml of 0.6% acetic acid solution was injected intraperitoneally per mouse. Timing was started immediately, and the number of writhing responses within 15 minutes after acetic acid injection was observed and recorded. Among them, the drug given to the drug group was the traditional Chinese medicine composition prepared according to the method of Example 1, and the drug given to the control group was the traditional Chinese medicine composition prepared according to the method of Comparative Preparation Example.

[0089] The experimental results are shown in Table 1.

[0090] Table 1 Effects on the number of writhing responses induced by acetic acid in mice (M ± SD, n = 10)

[0091] Group Dose (g crude drug / kg) Writhing times Model group Equal volume of normal water 25.1±4.82 Aspirin group 0.6 <![CDATA[7.6±5.45 ** > Control group 36 <![CDATA[14.9±6.30 * > High-dose drug group 36 <![CDATA[9.1±7.08 ** > Low-dose drug group 24 <![CDATA[15.1±7.03 * >

[0092] Note: Compared with the model group * P < 0.05, ** P < 0.01.

[0093] The results show that the traditional Chinese medicine composition of the present invention has a significant analgesic effect at medium doses and also has an obvious analgesic effect at low doses. Its analgesic effect on small pain is significantly better than that of the composition prepared by the Comparative Preparation Example.

[0094] Effect of Example 8 on the carbon particle clearance ability of mouse peripheral blood

[0095] Ruzengning Tablets, Guangdong Sanshun Pharmaceutical Co., Ltd., each tablet contains 0.6 g of dry extract.

[0096] Forty female mice were randomly divided into 4 groups, with 10 mice in each group: (1) normal group; (2) Ruzengning group (0.725 g / kg); (3) control group (10 g crude drug); (4) drug group (6 g crude drug / kg). Among them, the drug given to the drug group was the traditional Chinese medicine composition prepared according to the method of Example 5, and the drug given to the control group was the traditional Chinese medicine composition prepared according to the method of Comparative Preparation Example. After fasting for 12 hours, the corresponding drugs were administered by gavage according to the groups. 60 minutes after drug administration, each mouse was injected with Indian ink from the tail vein at a dose of 0.05 ml / 10 g. Blood was collected from the orbital cavity of each mouse 1 minute and 10 minutes after the injection of ink. 20 μl of blood was quickly aspirated into a test tube containing 2 ml of Na2CO3 (concentration 0.1%) solution and shaken well. The shaken Na2CO3 solution was subjected to colorimetry (λ = 680 nm). After the mice were sacrificed, the liver and spleen were taken out and the total weight of the two was weighed. The phagocytosis index was calculated according to the following formula, and the experimental results are shown in Table 2.

[0097] Phagocytosis index α = body weight / (liver weight + spleen weight) * K 1 / 3 , where K = (logOD1 - logOD2) / (t1 - t2).

[0098] Table 2 Effects on the carbon particle clearance ability of mice (M ± SD, n = 10)

[0099] Group Dose (g crude drug / kg) Phagocytic index α Model group Equal volume of normal water 5.84±0.65 Ruzengning group 4.35 <![CDATA[6.23±0.57 * > Control group 12 <![CDATA[6.19±0.63 * > Drug group 8 <![CDATA[6.25±0.53 * >

[0100] Note: Compared with the normal group * P < 0.05, ** P < 0.01.

[0101] The experimental results show that the drug composition of the present invention can significantly enhance the carbon particle clearance ability of the peripheral blood of mice and promote the non-specific immune function of mice even at low doses, and its effect on the immune function of mice is significantly better than that of the composition prepared by the comparative preparation example.

Claims

1. A traditional Chinese medicine composition, characterized in that, The composition is prepared by the following steps: Take raw materials: 5.3 - 12.3 parts of antler, 5.3 - 12.3 parts of fleece-flower root, 5.3 - 12.3 parts of fructus cnidii, 5.3 - 12.3 parts of cortex moutan, 5.3 - 12.3 parts of radix paeoniae rubra, 5.3 - 12.3 parts of thallus laminariae, 5.3 - 12.3 parts of radix curcumae and 13.7 - 19.7 parts of oyster; Step a): Extract the antler with water to obtain antler extract A; Step b): Steam-distill the cortex moutan, collect the distillate, refrigerate, and filter by suction to obtain paeonol crystals; filter the cortex moutan to obtain cortex moutan medicinal residues and aqueous solution for standby; Step c-1): Take fleece-flower root and radix paeoniae rubra, add 18 - 22 times the weight of the medicinal materials of 65 - 75% ethanol for reflux extraction, filter, and combine the ethanol extracts to obtain standby extract C1; Step c-2): Take fructus cnidii, thallus laminariae, oyster, radix curcumae, and combine them with the cortex moutan medicinal residues and the medicinal residues after extraction of fleece-flower root and radix paeoniae rubra, soak for 1.8 - 2.5 hours, extract with water 3 times, and collect the volatile oils of fructus cnidii and radix curcumae separately during the first extraction; combine the three aqueous extracts and the aqueous solution in step b), concentrate to a density of 1.05 - 1.10 at 60 °C, cool, adjust the alcohol content to 70% with ethanol, refrigerate, filter off the precipitate to obtain alcohol precipitation solution C2; Step d): Mix and process the alcohol precipitation solution C2, standby extract C1, antler extract A, paeonol, and volatile oils to prepare the composition.

2. The traditional Chinese medicine composition according to claim 1, wherein The water extraction method described in step a) is reflux extraction; the water consumption is 8 - 14 times the weight of the antler, preferably 9 - 12 times, and further preferably 10 times; the extraction times are 2 - 3 times, preferably 3 times; the extraction time is 2 - 3 hours, preferably 2 hours; furthermore, soak for 0.5 - 2 hours before refluxing, preferably soak for 1 hour.

3. The traditional Chinese medicine composition according to claim 1, wherein The volume of the distillate collected in step b) is 9 - 11 times the weight of the cortex moutan medicinal materials, preferably 10 times; the water consumption for distilling the cortex moutan is 14 - 16 times the weight of the cortex moutan; the refrigeration temperature is 0 - 10 °C, preferably 5 °C, and the refrigeration time is 20 - 50 hours, further 24 - 48 hours.

4. The traditional Chinese medicine composition according to claim 1, wherein The extraction times described in step c-1) are 2 - 4 times, preferably 3 times, and the extraction time is 1 - 2 hours, preferably 1.5 hours; the water consumption for water extraction in step c-2) is 8 - 12 times the total weight of the four medicinal materials of fructus cnidii, radix curcumae, oyster, and thallus laminariae, further 10 times; the ethanol with the alcohol content mentioned is 95% ethanol; the refrigeration temperature is 0 - 10 °C, preferably 5 °C, and the refrigeration time is 35 - 55 hours, further 40 - 50 hours.

5. The traditional Chinese medicine composition according to claim 1, wherein Before the alcohol precipitation solution C2 and the spare extraction solution C1 in step d) are mixed, they are combined, ethanol is recovered under reduced pressure and concentrated to an extract C with a relative density of 1.05 - 1.10; before the paeonol and the volatile oil are mixed, the crystals of paeonol are dissolved in 1 - 3 times the amount of anhydrous ethanol by weight, mixed with the volatile oil, and then 3 - 5 times the total weight of paeonol and cnidium monnieri volatile oil of β-cyclodextrin and an appropriate amount of 20% - 60% ethanol are added in portions, ground at 40 - 55 °C, and the obtained paste is dried in vacuo at 30 - 60 °C to obtain an inclusion compound F; the extract A is a concentrate of the water extraction solution obtained by water extraction, and preferably the concentrate is a thick paste A with a relative density of 1.05 - 1.15 at 60 °C.

6. The traditional Chinese medicine composition according to claim 6, wherein The extract C is mixed with the extract A and dried, to obtain an extract powder E, which is mixed with the inclusion compound F to obtain the traditional Chinese medicine composition.

7. The traditional Chinese medicine composition according to claim 1, wherein The raw materials are 7.3 - 9.3 parts of antler, 7.3 - 9.3 parts of polygonum multiflorum, 7.3 - 9.3 parts of cnidium monnieri, 7.3 - 9.3 parts of cortex moutan, 7.3 - 9.3 parts of radix paeoniae rubra, 7.3 - 9.3 parts of laminaria japonica, 7.3 - 9.3 parts of curcuma aromatica and 15.7 - 17.7 parts of oyster; further preferably, they are 8.3 parts of antler, 8.3 parts of polygonum multiflorum, 8.3 parts of cnidium monnieri, 8.3 parts of cortex moutan, 8.3 parts of radix paeoniae rubra, 8.3 parts of laminaria japonica, 8.3 parts of curcuma aromatica and 16.6 parts of oyster.

8. The traditional Chinese medicine composition according to claim 1, characterized in that In the said steps: Step a): The antler is soaked in 8 - 14 times the amount of water for 0.5 - 2 hours, decocted 2 - 3 times, and the water extraction solution is concentrated to a relative density of 1.05 - 1.15 at 60 °C to obtain an extract A; Step b): The cortex moutan is subjected to steam distillation with 14 - 16 times its weight of water, the distillate is collected until it reaches 9 - 11 times the weight of the cortex moutan medicinal material, refrigerated at 0 - 10 °C for 24 - 48 hours, and filtered to obtain paeonol crystals; the medicinal residues are filtered to obtain the cortex moutan medicinal residues and the aqueous solution for standby; Step c): First, take polygonum multiflorum and radix paeoniae rubra, add 18 - 22 times the weight of the medicinal materials of 65% - 75% ethanol for reflux extraction 2 - 3 times, each time for 1 - 2 hours, and combine the ethanol extraction solutions to obtain a spare extraction solution C1; take cnidium monnieri, laminaria japonica, oyster, curcuma aromatica, combine them with the cortex moutan medicinal residues and the medicinal residues extracted from polygonum multiflorum and radix paeoniae rubra, add 8 - 12 times the amount of water based on the total weight of the four medicinal materials of cnidium monnieri, curcuma aromatica, oyster and laminaria japonica, decoct 3 times, each time for 1.8 - 2.5 hours, and at the same time collect the volatile oils of cnidium monnieri and curcuma aromatica and store them separately. Combine the three decoction solutions and the aqueous solution in step b), concentrate to a density of 1.05 - 1.10 at 60 °C, adjust the ethanol content to 70% with ethanol, refrigerate at 0 - 10 °C for 35 - 55 hours, filter off the precipitate, combine the alcohol precipitation solution with the above-mentioned spare extraction solution C1, recover ethanol under reduced pressure and concentrate to a relative density of 1.05 - 1.10 to obtain an extract C; combine the extract C with the extract A, stir well, dry and pulverize to obtain an extract powder E; Step e): Dissolve the crystallization of paeonol in 1 - 3 times its weight of absolute ethanol, mix it with the volatile oil, then add in portions 3 - 5 times the total weight of paeonol and the volatile oil of Cnidium monnieri (L.) Cuss. of β - cyclodextrin and an appropriate amount of 20% - 60% ethanol, grind at 40 - 55°C, and vacuum - dry the obtained paste at 30 - 60°C to obtain the inclusion compound. Step f): Mix the extract powder E from step d) with the inclusion compound from step e) to prepare the composition.

9. The traditional Chinese medicine composition according to claim 1, wherein The said composition includes pharmaceutically acceptable excipients.

10. A preparation method of a traditional Chinese medicine composition, characterized in that, It includes the following steps: Take the raw materials: 5.3 - 12.3 parts of Cornu Cervi Pantotrichum, 5.3 - 12.3 parts of Polygonum multiflorum Thunb., 5.3 - 12.3 parts of Cnidium monnieri (L.) Cuss., 5.3 - 12.3 parts of Cortex Moutan, 5.3 - 12.3 parts of Radix Paeoniae Rubra, 5.3 - 12.3 parts of Ecklonia kurome, 5.3 - 12.3 parts of Curcuma aromatica Salisb., and 13.7 - 19.7 parts of Concha Ostreae. Step a): Soak Cornu Cervi Pantotrichum in 8 - 14 times its weight of water for 0.5 - 2 hours, then decoct 2 - 3 times, concentrate the water extract to a relative density of 1.05 - 1.15 at 60°C to obtain extract A. Step b): Perform steam distillation on Cortex Moutan with 14 - 16 times its weight of water, collect the distillate until it reaches 9 - 11 times the weight of the Cortex Moutan medicinal material, refrigerate at 0 - 10°C for 24 - 48 hours, filter to obtain the paeonol crystallization; filter the medicinal residues to obtain the Cortex Moutan medicinal residues and the aqueous solution for standby. Step c): First, take Polygonum multiflorum Thunb. and Radix Paeoniae Rubra, add 18 - 22 times the weight of the medicinal materials of 65% - 75% ethanol for reflux extraction 2 - 3 times, each time for 1 - 2 hours, combine the ethanol extracts to obtain the standby extract C1; take Cnidium monnieri (L.) Cuss., Ecklonia kurome, Concha Ostreae, Curcuma aromatica Salisb., combine them with the Cortex Moutan medicinal residues and the medicinal residues after extraction of Polygonum multiflorum Thunb. and Radix Paeoniae Rubra, add 8 - 12 times the weight of the total weight of the four medicinal materials of Cnidium monnieri (L.) Cuss., Curcuma aromatica Salisb., Concha Ostreae, and Ecklonia kurome of water, decoct 3 times, each time for 1.8 - 2.5 hours, collect the volatile oils of Cnidium monnieri (L.) Cuss. and Curcuma aromatica Salisb. separately for storage at the same time, combine the three decoction liquids and the aqueous solution in step b), concentrate to a density of 1.05 - 1.10 at 60°C, adjust the ethanol content to 70% with ethanol, refrigerate at 0 - 10°C for 35 - 55 hours, filter to remove the precipitate, combine the ethanol - precipitated solution with the above - mentioned standby extract C1, recover ethanol under reduced pressure and concentrate to a relative density of 1.05 - 1.10 to obtain extract C; combine extract C with extract A, stir evenly, dry, and pulverize to obtain extract powder E. Step e): Dissolve the crystallization of paeonol in 1 - 3 times its weight of absolute ethanol, mix it with the volatile oil, then add in portions 3 - 5 times the total weight of paeonol and the volatile oil of Cnidium monnieri (L.) Cuss. of β - cyclodextrin and an appropriate amount of 20% - 60% ethanol, grind at 40 - 55°C, and vacuum - dry the obtained paste at 30 - 60°C to obtain the inclusion compound. Step f): Mix the extract powder E from step d) with the inclusion compound from step e) to prepare the composition.