Pills are made from fine powder or extract of drugs with appropriate binders (or excipients), and the most widely used is honey pills made with honey as an excipient. The production process of honey pills is long, and there are factors that affect the quality of honey pills in each process from raw materials to finished product packaging. This article discusses the main factors affecting the quality of honey pills and the key points of quality control.

　1、 Pollution of honey pills

The problem of bacterial contamination in honey pills is very serious and difficult to solve, which directly affects the quality of drugs and people's health. It is also one of the reasons why honey pills cannot be exported to the market in large quantities. When using our factory's pill making machine for production, be sure to pay attention and clean the machine thoroughly after each use. The main pathways for contamination of honey pills, such as bacterial contamination of the original medicinal materials; Production workshopPharmaceutical equipmentDisinfection of vessels and operators; The sterilization of packaging materials and other measures can be taken as key points for quality control, including:

1.1 Strengthen the pre-treatment of raw medicinal materials. This is the key to preventing bacteria. The medicinal herbs used in the prescription must be processed and qualified before they can be used as raw materials, and single herb sterilization treatment should be carried out according to the different properties of the herbs. If sterilization is carried out using methods such as dry heat, high-frequency microwave, far-infrared radiation, and ethylene oxide fumigation.

1.2 Strictly control the pollution throughout the entire process of pill making. The following aspects of control should be strengthened:

1.2.1 Prevent bacterial contamination during the crushing process.

1.2.2 Before adding ingredients, the bacterial count of the powder should be checked.

1.2.3 Honey must be refined and mixed with circulating steam before use.

1.2.4 The entire process from ingredients to finished product packaging should be carried out using aseptic operations.

1.3 The finished product must be sterilized using appropriate methods. Such as 60Co - γ - ray irradiation method, pressure sterilization method, microwave heating sterilization method, etc.

　2、 Quality and Refining of Honey

The selection of honey is a key issue in making the honey pills moisturized, soft, and not spoiled during storage. The preparation of honey pills should use milky white or light yellow, viscous syrup like or semi fluid like, pure and sweet in taste, fragrant, non sour, non astringent, oily, low in moisture, starch and impurities. The quality of honey refining is the key to making good honey pills. If not refined properly, honey pills are prone to quality problems such as wrinkling, mold growth, dryness, cracking, and sand return during storage. Therefore, quality monitoring can be carried out in the following aspects during production:

2.1 After heating and dissolving honey, it should be sieved to remove impurities such as bee carcasses and foam, and then further refined according to requirements.

2.2 Determine the degree of honey refinement based on the properties of the medication in the prescription. Handheld sugar meters or specific gravity meters can be used, combined with indicators such as color, bubbles, viscosity, and refining temperature to control the moisture content of the honey, resulting in tender honey (105-115 ℃, moisture content of 18% -20%, density of about 1.34); Zhongmi (116-118 ℃, moisture content of 14% -16%, density of about 1.37); Honey (119-122 ℃, moisture content below 10%, density around 1.40).

2.3 Refined honey should be used while it is hot or stored in a closed container. If necessary, appropriate non-toxic preservatives can be added according to actual needs.

　　3、 Honey pills are hard

The most common quality issue that occurs during the production and storage of honey pills is the hardness of the pills. The main reasons for this situation are: insufficient honey usage; Honey temperature is low; Honey refining is too old; The proportion of drugs containing glue or resin is relatively high, and the temperature during agglomeration is too high, causing them to dissolve. After cooling, they become hard; The fineness of the medicinal powder is not fixed and affects the ratio of honey content; Seasonal changes, etc. Quality control can be carried out in the following aspects during production:

3.1 The medicinal powder must be sieved and mixed evenly, with a fixed fineness, generally between 100-120 mesh.

3.2 Determine the degree of honey refining, the amount of honey used, and the temperature at which honey is mixed based on the properties of the medicinal powder.

3.2.1 For mineral drugs with poor viscosity or drugs with strong fibrous properties, honey is generally used. The ratio of honey to powder is about 2:1, and the honey temperature is 90-120 ℃.

3.2.2 For general drugs and drugs containing some sugar and oil, honey is generally used. The ratio of honey to powder is about 1:1, and the honey temperature is 70-80 ℃.

3.2.3 For drugs containing a high amount of oil, mucus, sugar, starch, and animal tissue, tender honey is generally used. The ratio of honey to powder is about 0.5:1, and the honey temperature is 40-50 ℃.

When the prescription contains aromatic volatile drugs, they should be stored at 40-50 ℃ to prevent the effective ingredients from dispersing and affecting the therapeutic effect.

3.3 When manually combining medicine and making pills, it is advisable to use more honey, while when mechanically combining medicine and making pills, it is advisable to use less honey. The amount of honey should be adjusted appropriately according to seasonal changes, with less in summer and more in winter.

3.4 After honey is mixed, it should be left for a period of time to allow the honey to fully soak the medicinal material, expand to produce a certain viscosity, and then knead and pill.

The packaging of 3.5 honey pills should be tight. Different packaging materials and methods can be used according to the properties of the pills. For honey pills that require long-term storage and contain a high amount of aromatic volatile compounds, wax shells, ceramic bottles, and other sealing methods can be used; Ordinary honey pills and large honey pills with less fine ingredients can be sealed with wax paper tubes, plastic foam, etc; For easily hygroscopic honey pills, glass bottles or tubes can be used for packaging.

The factors that affect the quality of honey pills are very complex. The above only discusses the quality control issues in the production process of honey pills. Among all the influencing factors, human factors are the most important. Therefore, as long as we strictly implement GMP standards in production, strengthen comprehensive quality management, focus on personnel quality training, raw material pretreatment, honey refining quality, strictly follow operating procedures for production, and take effective sterilization measures, the quality of honey pills will definitely be significantly improved. However, the qualitative and quantitative analysis of active ingredients in pills, the control of toxic ingredient content, and the study of bioavailability and other internal quality control work still require a lot of practice and research by traditional Chinese medicine workers.